CompletedNCT03475186Updated Mar 13, 2026Results posted

Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

A Phase 2 interventional study of Ramipril in Glioblastoma, Radiotherapy; Complications and Cognitive Decline, sponsored by Wake Forest University Health Sciences. Completed at 423 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-13.

Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Supportive care

Phase: Phase 2
Study type: Interventional
Enrollment: 75
Allocation: Not applicable
Ages: 18 Years and older
Sex: All

Study summary

This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

Read the detailed description

This is a pilot study of an oral drug Ramipril to prevent cognitive decline in glioblastoma patients receiving partial brain radiation and concurrent and adjuvant temozolomide . Ramipril will be titrated to the highest tolerable dose during chemoradiation (2.5-5 mg). Once this dose is determined, the patient will continue at this dose for 4 months after the completion of chemoradiation. Patients will be followed until 5 months post chemoradiation for compliance, toxicity, cognitive decline and participant reported outcomes (PRO).

Conditions studied

Glioblastoma
Radiotherapy; Complications
Cognitive Decline
Chemoradiation

Browse trials for

Keywords

Memory
Brain Cancer
Ramipril

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Histologically proven diagnosis of glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV) obtained at the time of a partial or gross total resection of the tumor. Patients who undergo a stereotactic needle biopsy alone are not eligible.
The tumor must have a supratentorial component.
History/physical examination within 14 days prior to enrollment.
The patient must have recovered from the effects of surgery, postoperative infection, and other complications before enrollment
Patient planning to receive brain RT, and concurrent and adjuvant temozolomide chemotherapy for six weeks as per standard of care therapy. Use of the Optune® (also known as Tumor Treating Fields or TTFields) device is allowed at provider discretion, but must begin after the Month 1 Post RT (10 week [wk]) Neurocognitive-PRO assessment.
Study drug (Ramipril) must be given >= 21 days and ≤ 42 days after surgery.
All available brain magnetic resonance imaging (MRI) or computed tomography (CT) imaging reports from surgery to study completion must be submitted. This includes any post-operative or pre-radiation scan reports.
Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
Absolute neutrophil count (ANC) >= 1,500 cells/mm\^3 (obtained within 14 days prior to enrollment)
Platelets >= 100,000 cells/mm\^3 (obtained within 14 days prior to enrollment)
Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable) (obtained within 14 days prior to enrollment)
Blood urea nitrogen (BUN) =\< 30 mg/dl within 14 days prior to enrollment
Creatinine =\< 1.7 mg/dl within 14 days prior to enrollment
Total bilirubin =\< 2.0 mg/dl within 14 days prior to enrollment
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =\< 3 x normal range within 14 days prior to enrollment
Patient must provide study specific informed consent prior to study entry
Baseline potassium level \<5.0 mEq/L. High potassium values that are thought to be a result of sample hemolysis may be repeated to determine an accurate potassium level and to determine potential study eligibility. Likewise high potassium values thought to be a result of potassium supplementation may be repeated at an appropriate time (5 half-lives after supplement discontinuation) to determine potential study eligibility.

Patient must be able to complete neurocognitive tests in the English language

Women of childbearing potential and male participants must practice adequate contraception
For females of child-bearing potential, negative serum or urine pregnancy test within 14 days of enrollment
Local site must be follow the standard GBM radiation treatment dosimetry plan
For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following inclusion criteria also apply:
Patients must have only a supratentorial glioblastoma
The treating physician must be a qualified provider having successfully completed the training course provided by Novocure, the device manufacturer
Patients with prior malignancies if all treatment for that malignancy was completed at least 2 years before registration and the patient has no evidence of disease.

Exclusion criteria

Exclusion Criteria:

Prior allergic reaction or intolerance to angiotensin-converting-enzyme (ACE) inhibitor
Hypotension (\< 110 mg Hg systolic) at the time of enrollment
Renal insufficiency with creatinine clearance of \< 40 ml/min (at time of enrollment)
Solitary kidney or known renal artery stenosis
Current ACE inhibitor or angiotensin receptor blocker use. Patients can come off ACE inhibitors or angiotensin receptor blockers for 1 week to be eligible for this study.
Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 2 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).
Recurrent or multifocal malignant gliomas
Metastases detected below the tentorium or beyond the cranial vault
Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
Severe active co-morbidity, defined as follows:
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment.
Known HIV positivity or acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study unless they involve standard of care or over the counter therapies or do not involve a drug therapy.
Patients planning to receive therapeutic antitumor agents (excluding use of the Tumor Treating Fields (TTFields or Optune®) device after the Month 1 Post RT (10 wk) Neurocognitive-PRO assessment.) in addition to standard radiation and concurrent and adjuvant temozolomide are not eligible to participate in this study.
Patients with impaired decision-making capacity; this exclusion is necessary because such patients may not be able to adequately give informed consent.
Pregnant or lactating women, due to possible adverse effect on the developing fetus or infant due to study drug.
For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following exclusion criteria also apply:
Optune® is not permitted in patients who have an active implanted medical device, skull defect (such as, missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmatic shunts.
Optune® is not permitted in patients who are known to be sensitive to conductive hydrogels. Examples of conductive hydrogels are gels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
Patients being treated with Memantine, Donepezil, and/or medications prescribed to enhance cognition.

Study design

Phase: Phase 2
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 75 participants (actual)

Study arms

Experimental
Ramipril
Ramipril will be taken once daily by mouth. It will be titrated during the first 3 weeks of chemoradiation to the highest tolerable dose (2.5-5 mg). This dose will be taken each day until 4 months post-chemoradiation treatment (22 weeks).
Drug: Ramipril

Interventions

DrugRamipril
2.5 - 5 mg oral, 1x daily for 22 weeks
Also known as: Altace, Tritace

What researchers measure

Primary outcomes

Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Standardized Score
HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-36) for part A Total Recall is calculated as the total number of words correctly recalled amongst the three trials. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: Baseline,10 weeks
Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Standardized Score
HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-12) for part B Delayed Recall is calculated as the number of words correctly recalled. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: Baseline,10 weeks
Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recognition Standardized Score
HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (-12-12) for part C Delayed Recognition is calculated as the number of incorrectly identified words subtracted from the number of correctly identified words. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: Baseline,10 weeks
Change From Baseline Neurocognitive Function at 10 Weeks - Trail Making Test Part A (TMT A) Standardized Score
Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. The raw score for TMT-A is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: Baseline,10 weeks
Change From Baseline Neurocognitive Function at 10 Weeks - Trail Making Test Part B (TMT B) Standardized Score
TMT-B requires subjects to connect 25 dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The raw score TMT-B is the total time in seconds required to complete the task. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: Baseline,10 weeks
Change From Baseline Neurocognitive Function at 10 Weeks - Controlled Oral Word Association Test (COWA) Standardized Scores
The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter. The raw score on the COWA (0-87) is the total number of words named across the three trials minus repetitions. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: Baseline,10 weeks
Efficacy of Ramipril of Neurocognitive Function at Baseline - Shipley Institute of Living Scale-Version 2 Vocabulary
Shipley Institute of Living Scale provides an assessment of premorbid intellectual functioning comparable to a verbal IQ and thus is a proxy for cognitive reserve. This vocabulary test requires respondents to read a target word and select one of four words that most closely means the same thing. The score is total correct of 40 items (0-40). Higher scores indicate a better outcome.
Time frame: Baseline
Retention Rate at 10 Weeks
Measured by the percent of patients who took 75% of the Ramipril doses and completed the neurocognitive battery of tests
Time frame: 10 weeks

Secondary outcomes

Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Global HRQOL Scale
A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL.
Time frame: Baseline, 6 weeks, 10 weeks, 22 weeks
Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Physical Functioning Scale
A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL.
Time frame: Baseline, 6 weeks, 10 weeks, 22 weeks
Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Cognitive Functioning Scale
A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL.
Time frame: Baseline, 6 weeks, 10 weeks, 22 weeks
Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Social Functioning Scale
A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL.
Time frame: Baseline, 6 weeks, 10 weeks, 22 weeks
Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Motor Dysfunction
A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms.
Time frame: Baseline, 6 weeks, 10 weeks, 22 weeks
Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Communication Deficit
A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms.
Time frame: Baseline, 6 weeks, 10 weeks, 22 weeks
Number of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Total Recall
Measured by presence of a decline of the HVLT-R Total Recall standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.
Time frame: Baseline - 22 weeks
Number of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Delayed Recall
Measured by presence of a decline of the HVLT-R Delayed Recall standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.
Time frame: Baseline - 22 weeks
Number of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Recognition
Measured by presence of a decline of the HVLT-R Recognition standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.
Time frame: Baseline - 22 weeks
Number of Participants With Neurocognitive Decline- Trail Making Test Part A (TMT A)
Measured by presence of a decline of the TMT-A standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.
Time frame: Baseline - 22 weeks
Number of Participants With Neurocognitive Decline- Trail Making Test Part B (TMT B)
Measured by presence of a decline of the TMT-B standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.
Time frame: Baseline - 22 weeks
Number of Participants With Neurocognitive Decline- Controlled Oral Word Association Test (COWA)
Measured by presence of a decline of the COWA standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.
Time frame: Baseline - 22 weeks
Determine Presence of Apolipoprotein Epsilon (ApoE)
Measured by quantitative polymerase chain reaction (PCR) using patient serum via a blood test
Time frame: Baseline
Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Standardized Score
A comparison of HVLT-R Total Recall standardized scores between groups at study end. HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-36) for part A Total Recall is calculated as the total number of words correctly recalled amongst the three trials. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Standardized Score
A comparison of HVLT-R Delayed Recall standardized scores between groups at study end. HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-12) for part B Delayed Recall is calculated as the number of words correctly recalled. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recognition Standardized Score
A comparison of HVLT-R Delayed Recognition standardized scores between groups at study end. HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (-12-12) for part C Delayed Recognition is calculated as the number of incorrectly identified words subtracted from the number of correctly identified words. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- Trail Making Test Part A (TMT A) Standardized Score
A comparison of TMT-A standardized scores between groups at study end. Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. The raw score for TMT-A is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- Trail Making Test Part B (TMT B) Standardized Score
A comparison of TMT-B standardized scores between groups at study end. TMT-B requires subjects to connect 25 dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The raw score TMT-B is the total time in seconds required to complete the task. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- Controlled Oral Word Association Test (COWA) Standardized Score
A comparison of COWA standardized scores between groups at study end. The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter. The raw score on the COWA (0-87) is the total number of words named across the three trials minus repetitions. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Global HRQOL Scale
Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. Scores are compared with the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Physical Functioning Scale
Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. Scores are compared with the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Cognitive Functioning Scale
Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. Scores are compared with the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Social Functioning Scale
Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. Scores are compared with the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Motor Dysfunction
Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms. Scores are compared with the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Communication Deficit
Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms. Scores are compared with the control arm of RTOG0825 (NCT00884741).
Time frame: 22 weeks

Results

Posted Mar 13, 2026

Participant flow

During Radiotherapy

Participant flow — During Radiotherapy
Milestone	Ramipril
Started	75
Completed	61
Not completed	14
Withdrew: Physician decision	3
Withdrew: Creatinine increased	2
Withdrew: Lost to follow-up	1
Withdrew: Too sick or ill	1
Withdrew: Hospice	1
Withdrew: Did not like the study assessments/questionnaires	1
Withdrew: Did not like the intervention	1
Withdrew: Overwhelmed	1
Withdrew: Non-compliance	1
Withdrew: Other	2

Primary Endpoint: 1-Month Post-RT

Participant flow — Primary Endpoint: 1-Month Post-RT
Milestone	Ramipril
Started	61
Completed	56
Not completed	5
Withdrew: Hospice	3
Withdrew: Disease progression	1
Withdrew: Other	1

4-Months Post-RT

Participant flow — 4-Months Post-RT
Milestone	Ramipril
Started	56
Completed	46
Not completed	10
Withdrew: Disease progression	3
Withdrew: Too sick or ill	3
Withdrew: Physician decision	2
Withdrew: Hospice	2

Follow-Up: 5-Months Post-RT

Participant flow — Follow-Up: 5-Months Post-RT
Milestone	Ramipril
Started	46
Completed	43
Not completed	3
Withdrew: Death	2
Withdrew: Overwhelmed	1

Outcome measures

PrimaryChange From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Standardized Score

HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-36) for part A Total Recall is calculated as the total number of words correctly recalled amongst the three trials. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: Baseline,10 weeks
Reported as:: Median · Change in standardized score

Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Standardized Score
Change in standardized score	Ramipril	RTOG 0825 Control Arm
Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Standardized Score	0.09 (-0.73 to 0.47)	-0.40 (-1.10 to 0.50)

Statistical analysis

Ramipril vs RTOG 0825 Control Arm · Rank-based Estimates of Regression Coeff · p = 0.33 (The p-value is not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.)Adjusted for patient characteristics that were imbalanced at baseline.

PrimaryChange From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Standardized Score

HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-12) for part B Delayed Recall is calculated as the number of words correctly recalled. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: Baseline,10 weeks
Reported as:: Median · Change in standardized score

Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Standardized Score
Change in standardized score	Ramipril	RTOG 0825 Control Arm
Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Standardized Score	0.00 (-0.71 to 0.59)	-0.60 (-1.60 to 0.00)

Statistical analysis

Ramipril vs RTOG 0825 Control Arm · Rank-based Estimates of Regression Coeff · p = 0.04 (The p-value is not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.)Adjusted for patient characteristics that were imbalanced at baseline.

PrimaryChange From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recognition Standardized Score

HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (-12-12) for part C Delayed Recognition is calculated as the number of incorrectly identified words subtracted from the number of correctly identified words. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: Baseline,10 weeks
Reported as:: Median · Change in standardized score

Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recognition Standardized Score
Change in standardized score	Ramipril	RTOG 0825 Control Arm
Change From Baseline Neurocognitive Function at 10 Weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recognition Standardized Score	-0.23 (-1.13 to 0.59)	0.00 (-0.90 to 0.90)

Statistical analysis

Ramipril vs RTOG 0825 Control Arm · Rank-based Estimates of Regression Coeff · p = 0.29 (The p-value is not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.)Adjusted for patient characteristics that were imbalanced at baseline.

PrimaryChange From Baseline Neurocognitive Function at 10 Weeks - Trail Making Test Part A (TMT A) Standardized Score

Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. The raw score for TMT-A is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: Baseline,10 weeks
Reported as:: Median · Change in standardized score

Change From Baseline Neurocognitive Function at 10 Weeks - Trail Making Test Part A (TMT A) Standardized Score
Change in standardized score	Ramipril	RTOG 0825 Control Arm
Change From Baseline Neurocognitive Function at 10 Weeks - Trail Making Test Part A (TMT A) Standardized Score	0.35 (-1.38 to 1.15)	0.30 (-0.40 to 1.40)

Statistical analysis

Ramipril vs RTOG 0825 Control Arm · Rank-based Estimates of Regression Coeff · p = 0.39 (The p-value is not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.)Adjusted for patient characteristics that were imbalanced at baseline.

PrimaryChange From Baseline Neurocognitive Function at 10 Weeks - Trail Making Test Part B (TMT B) Standardized Score

TMT-B requires subjects to connect 25 dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The raw score TMT-B is the total time in seconds required to complete the task. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: Baseline,10 weeks
Reported as:: Median · Change in standardized score

Change From Baseline Neurocognitive Function at 10 Weeks - Trail Making Test Part B (TMT B) Standardized Score
Change in standardized score	Ramipril	RTOG 0825 Control Arm
Change From Baseline Neurocognitive Function at 10 Weeks - Trail Making Test Part B (TMT B) Standardized Score	0.33 (-2.58 to 1.32)	0.00 (-1.40 to 1.30)

Statistical analysis

Ramipril vs RTOG 0825 Control Arm · Rank-based Estimates of Regression Coeff · p = 0.91 (The p-value is not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.)Adjusted for patient characteristics that were imbalanced at baseline.

PrimaryChange From Baseline Neurocognitive Function at 10 Weeks - Controlled Oral Word Association Test (COWA) Standardized Scores

The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter. The raw score on the COWA (0-87) is the total number of words named across the three trials minus repetitions. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: Baseline,10 weeks
Reported as:: Median · Change in standardized score

Change From Baseline Neurocognitive Function at 10 Weeks - Controlled Oral Word Association Test (COWA) Standardized Scores
Change in standardized score	Ramipril	RTOG 0825 Control Arm
Change From Baseline Neurocognitive Function at 10 Weeks - Controlled Oral Word Association Test (COWA) Standardized Scores	0.20 (-0.31 to 0.71)	0.00 (-0.60 to 0.70)

Statistical analysis

Ramipril vs RTOG 0825 Control Arm · Rank-based Estimates of Regression Coeff · p = 0.44 (The p-value is not adjusted for multiple comparisons. P\<0.05 was considered statistically significant.)Adjusted for patient characteristics that were imbalanced at baseline.

PrimaryEfficacy of Ramipril of Neurocognitive Function at Baseline - Shipley Institute of Living Scale-Version 2 Vocabulary

Shipley Institute of Living Scale provides an assessment of premorbid intellectual functioning comparable to a verbal IQ and thus is a proxy for cognitive reserve. This vocabulary test requires respondents to read a target word and select one of four words that most closely means the same thing. The score is total correct of 40 items (0-40). Higher scores indicate a better outcome.

Time frame:: Baseline
Reported as:: Median · score on a scale

Efficacy of Ramipril of Neurocognitive Function at Baseline - Shipley Institute of Living Scale-Version 2 Vocabulary
score on a scale	Ramipril
Efficacy of Ramipril of Neurocognitive Function at Baseline - Shipley Institute of Living Scale-Version 2 Vocabulary	31.0 (28.0 to 34.0)

PrimaryRetention Rate at 10 Weeks

Measured by the percent of patients who took 75% of the Ramipril doses and completed the neurocognitive battery of tests

Time frame:: 10 weeks
Reported as:: Number · Percentage of participants

Retention Rate at 10 Weeks
Percentage of participants	Ramipril
Retention Rate at 10 Weeks	48 (38 to 100)

SecondaryEfficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Global HRQOL Scale

A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL.

Time frame:: Baseline, 6 weeks, 10 weeks, 22 weeks
Reported as:: Median · score on a scale

Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Global HRQOL Scale
score on a scale	Ramipril
Baseline	66.67 (50.00 to 83.33)
6 Weeks	66.67 (50.00 to 83.33)
10 Weeks	75.00 (50.00 to 83.33)
22 Weeks	75.00 (54.17 to 83.33)

SecondaryEfficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Physical Functioning Scale

Time frame:: Baseline, 6 weeks, 10 weeks, 22 weeks
Reported as:: Median · score on a scale

Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Physical Functioning Scale
score on a scale	Ramipril
Baseline	93.33 (80.00 to 100.00)
6 Weeks	80.00 (66.67 to 93.33)
10 Weeks	86.67 (73.33 to 93.33)
22 Weeks	86.67 (80.00 to 100.00)

SecondaryEfficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Cognitive Functioning Scale

Time frame:: Baseline, 6 weeks, 10 weeks, 22 weeks
Reported as:: Median · score on a scale

Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Cognitive Functioning Scale
score on a scale	Ramipril
Baseline	66.67 (50.00 to 100.00)
6 Weeks	83.33 (66.67 to 100.00)
10 Weeks	83.33 (66.67 to 100.00)
22 Weeks	75.00 (66.67 to 100.00)

SecondaryEfficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Social Functioning Scale

Time frame:: Baseline, 6 weeks, 10 weeks, 22 weeks
Reported as:: Median · score on a scale

Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Social Functioning Scale
score on a scale	Ramipril
Baseline	66.67 (50.00 to 100.00)
6 Weeks	66.67 (50.00 to 83.33)
10 Weeks	83.33 (50.00 to 100.00)
22 Weeks	66.67 (66.67 to 100.00)

SecondaryEfficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Motor Dysfunction

A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms.

Time frame:: Baseline, 6 weeks, 10 weeks, 22 weeks
Reported as:: Median · score on a scale

Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Motor Dysfunction
score on a scale	Ramipril
Baseline	11.11 (0.00 to 33.33)
6 Weeks	11.11 (0.00 to 33.33)
10 Weeks	11.11 (0.00 to 33.33)
22 Weeks	11.11 (0.00 to 27.78)

SecondaryEfficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Communication Deficit

A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms.

Time frame:: Baseline, 6 weeks, 10 weeks, 22 weeks
Reported as:: Median · score on a scale

Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) - Communication Deficit
score on a scale	Ramipril
Baseline	11.11 (0.00 to 38.89)
6 Weeks	11.11 (0.00 to 33.33)
10 Weeks	11.11 (0.00 to 33.33)
22 Weeks	16.67 (0.00 to 33.33)

SecondaryNumber of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Total Recall

Measured by presence of a decline of the HVLT-R Total Recall standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.

Time frame:: Baseline - 22 weeks
Reported as:: Count of participants · Participants

Number of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Total Recall
Participants	Ramipril
Week 6	9
Week 10	10
Week 22	11

SecondaryNumber of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Delayed Recall

Measured by presence of a decline of the HVLT-R Delayed Recall standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.

Time frame:: Baseline - 22 weeks
Reported as:: Count of participants · Participants

Number of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Delayed Recall
Participants	Ramipril
Week 6	14
Week 10	8
Week 22	6

SecondaryNumber of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Recognition

Measured by presence of a decline of the HVLT-R Recognition standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.

Time frame:: Baseline - 22 weeks
Reported as:: Count of participants · Participants

Number of Participants With Neurocognitive Decline- Hopkins Verbal Learning Test-Revised (HVLT-R) - Recognition
Participants	Ramipril
Week 6	21
Week 10	13
Week 22	13

SecondaryNumber of Participants With Neurocognitive Decline- Trail Making Test Part A (TMT A)

Measured by presence of a decline of the TMT-A standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.

Time frame:: Baseline - 22 weeks
Reported as:: Count of participants · Participants

Number of Participants With Neurocognitive Decline- Trail Making Test Part A (TMT A)
Participants	Ramipril
Week 6	10
Week 10	12
Week 22	8

SecondaryNumber of Participants With Neurocognitive Decline- Trail Making Test Part B (TMT B)

Measured by presence of a decline of the TMT-B standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.

Time frame:: Baseline - 22 weeks
Reported as:: Count of participants · Participants

Number of Participants With Neurocognitive Decline- Trail Making Test Part B (TMT B)
Participants	Ramipril
Week 6	13
Week 10	14
Week 22	9

SecondaryNumber of Participants With Neurocognitive Decline- Controlled Oral Word Association Test (COWA)

Measured by presence of a decline of the COWA standardized score at each timepoint of cognitive assessment. Decline will be defined as a change greater than the reliable change index (RCI) for any of the individual cognitive tests is experienced for a particular patient. Clinical trial battery scores were standardized on normative data.

Time frame:: Baseline - 22 weeks
Reported as:: Count of participants · Participants

Number of Participants With Neurocognitive Decline- Controlled Oral Word Association Test (COWA)
Participants	Ramipril
Week 6	3
Week 10	3
Week 22	3

SecondaryDetermine Presence of Apolipoprotein Epsilon (ApoE)

Measured by quantitative polymerase chain reaction (PCR) using patient serum via a blood test

Time frame:: Baseline

No measurements were reported for this outcome.

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Standardized Score

A comparison of HVLT-R Total Recall standardized scores between groups at study end. HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-36) for part A Total Recall is calculated as the total number of words correctly recalled amongst the three trials. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Standardized Score
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Standardized Score	-1.15 (-2.49 to 0.12)	-1.50 (-2.90 to 0.10)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Standardized Score

A comparison of HVLT-R Delayed Recall standardized scores between groups at study end. HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (0-12) for part B Delayed Recall is calculated as the number of words correctly recalled. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Standardized Score
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recall Standardized Score	-0.96 (-2.11 to -0.18)	-1.40 (-3.10 to 0.10)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recognition Standardized Score

A comparison of HVLT-R Delayed Recognition standardized scores between groups at study end. HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R. A raw score (-12-12) for part C Delayed Recognition is calculated as the number of incorrectly identified words subtracted from the number of correctly identified words. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recognition Standardized Score
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- Hopkins Verbal Learning Test-Revised (HVLT-R) Delayed Recognition Standardized Score	-0.57 (-2.00 to 0.27)	-1.10 (-2.90 to 0.10)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- Trail Making Test Part A (TMT A) Standardized Score

A comparison of TMT-A standardized scores between groups at study end. Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. The raw score for TMT-A is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- Trail Making Test Part A (TMT A) Standardized Score
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- Trail Making Test Part A (TMT A) Standardized Score	-0.16 (-1.36 to 0.75)	-0.20 (-1.50 to 0.70)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- Trail Making Test Part B (TMT B) Standardized Score

A comparison of TMT-B standardized scores between groups at study end. TMT-B requires subjects to connect 25 dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The raw score TMT-B is the total time in seconds required to complete the task. If the assessment was not completed in the allotted time, a prorated score was calculated based on the last completed correct circle. Final prorated raw scores of total time were at least 0 seconds with no maximum limit. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- Trail Making Test Part B (TMT B) Standardized Score
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- Trail Making Test Part B (TMT B) Standardized Score	-0.40 (-4.29 to 0.57)	-1.40 (-3.70 to 0.50)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- Controlled Oral Word Association Test (COWA) Standardized Score

A comparison of COWA standardized scores between groups at study end. The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter. The raw score on the COWA (0-87) is the total number of words named across the three trials minus repetitions. Test scores are presented as standardized z scores (mean=0, sd=1) with infinite range. Higher standardized scores indicate better neurocognitive function. Change in standardized scores are compared with results from the control arm of RTOG0825 (NCT00884741).

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- Controlled Oral Word Association Test (COWA) Standardized Score
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- Controlled Oral Word Association Test (COWA) Standardized Score	-0.94 (-2.58 to 0.00)	-1.00 (-1.60 to 0.10)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Global HRQOL Scale

Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores indicate higher levels of functioning and health status/QoL. Scores are compared with the control arm of RTOG0825 (NCT00884741).

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Global HRQOL Scale
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Global HRQOL Scale	75.00 (54.17 to 83.33)	75.00 (66.70 to 83.33)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Physical Functioning Scale

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Physical Functioning Scale
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Physical Functioning Scale	86.67 (80.00 to 100.00)	86.70 (80.00 to 100.00)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Cognitive Functioning Scale

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Cognitive Functioning Scale
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Cognitive Functioning Scale	75.00 (66.67 to 100.00)	83.30 (66.70 to 83.30)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Social Functioning Scale

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Social Functioning Scale
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Social Functioning Scale	66.67 (66.67 to 100.00)	83.30 (66.67 to 100.00)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Motor Dysfunction

Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms. Scores are compared with the control arm of RTOG0825 (NCT00884741).

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Motor Dysfunction
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Motor Dysfunction	11.11 (0.00 to 27.78)	11.10 (0.00 to 22.20)

SecondaryEfficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Communication Deficit

Comparison of EORTCQLQ30/BN20 results between groups at study end -- a 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All scales and single-item measures range in score from 0 to 100 with standardization. Higher scores on a symptom scale represent more pronounced symptoms. Scores are compared with the control arm of RTOG0825 (NCT00884741).

Time frame:: 22 weeks
Reported as:: Median · score on a scale

Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Communication Deficit
score on a scale	Ramipril	RTOG 0825 Control Arm
Efficacy of Neurocognitive Function in Surviving Patients- EORTCQLQ30/BN20 - Communication Deficit	16.67 (0.00 to 33.33)	11.10 (0.00 to 33.30)

Adverse events

Collected over Enrollment to 26 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Ramipril	2/75 (2.7%)	8/75 (10.7%)	31/75 (41.3%)

Most frequent serious events

Most frequent serious events
Event	Ramipril
SeizureNervous system disorders	4/75
DehydrationMetabolism and nutrition disorders	1/75
EncephalopathyNervous system disorders	1/75
FallInjury, poisoning and procedural complications	1/75
HyponatremiaMetabolism and nutrition disorders	1/75
HypoxiaRespiratory, thoracic and mediastinal disorders	1/75
Lung infectionInfections and infestations	1/75
Renal CalculiRenal and urinary disorders	1/75
White blood cell decreasedInvestigations	1/75

Most frequent other events

Showing 10 of 61

Most frequent other events
Event	Ramipril
FatigueGeneral disorders	9/75
NauseaGastrointestinal disorders	8/75
ALT increasedInvestigations	7/75
ConstipationGastrointestinal disorders	6/75
HeadacheNervous system disorders	5/75
HyperglycemiaMetabolism and nutrition disorders	5/75
DizzinessNervous system disorders	4/75
HyponatremiaMetabolism and nutrition disorders	4/75
ThrombocytopeniaBlood and lymphatic system disorders	4/75
AlopeciaSkin and subcutaneous tissue disorders	3/75

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Ramipril
Median	63 (55 to 70)

Sex: Female, Male
Sex: Female, Male(Participants)	Ramipril
Female	26
Male	49

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Ramipril
Hispanic or Latino	3
Not Hispanic or Latino	72
Unknown or Not Reported	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Ramipril
American Indian or Alaska Native	0
Asian	0
Native Hawaiian or Other Pacific Islander	0
Black or African American	5
White	67
More than one race	1
Unknown or Not Reported	2

Baseline Symptom Burden
Baseline Symptom Burden(Participants)	Ramipril
Normal, no complaints, no symptoms of disease	18
Able to carry on normal activity, minor symptoms of disease	15
Normal activity with effort, some symptoms of disease	14
Require occasional assistance but able to care for most of personal needs	13
Care for self, unable to carry on normal activity or to do active work	6
Require considerable assistance for personal care	4
Unknown/No information	3

Number of times fallen in the last 6 months
Number of times fallen in the last 6 months(count)	Ramipril
Mean	0.76 ± 1.67

Medical history
Medical history(Participants)	Ramipril
Hypertension requiring medication	27
Diabetes	15
Liver disease	2
Hemiplegia	2
Congestive heart failure	1
Cerebrovascular disease	1
Chronic pulmonary disease	1
Other cancer	9
Other medical conditions	38
None	17
Myocardial infarction	0
Peripheral vascular disease	0
Connective tissue disease	0
Peptic ulcer disease	0
HIV/AIDS	0

Site of Lesion
Site of Lesion(Participants)	Ramipril
Frontal	20
Temporal	22
Parietal	11
Occipital	3
Basal ganglia	2
Multiple	10
None	5

5 further baseline measures are reported on the registry.

Study locations

423 sites

Anchorage Associates in Radiation Medicine
Anchorage, Alaska 98508, United States
Anchorage Radiation Therapy Center
Anchorage, Alaska 99504, United States
Alaska Breast Care and Surgery LLC
Anchorage, Alaska 99508, United States
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508, United States
Alaska Women's Cancer Care
Anchorage, Alaska 99508, United States
Anchorage Oncology Centre
Anchorage, Alaska 99508, United States
Katmai Oncology Group
Anchorage, Alaska 99508, United States
Providence Alaska Medical Center
Anchorage, Alaska 99508, United States
Cancer Center at Saint Joseph's
Phoenix, Arizona 85004, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903, United States
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs, Arkansas 71913, United States
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande, California 93420, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank, California 91505, United States
Aspirus Langlade Hospital
Irvine, California 92618, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California 90027, United States
Aspirus Regional Cancer Center
Sacramento, California 95816, United States
Aspirus Cancer Care - Wisconsin Rapids
Sacramento, California 95823, United States
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo, California 93401, United States
Mission Hope Medical Oncology - Santa Maria
Santa Maria, California 93444, United States
Penrose-Saint Francis Healthcare
Colorado Springs, Colorado 80907, United States
Rocky Mountain Cancer Centers-Penrose
Colorado Springs, Colorado 80907, United States
Saint Francis Cancer Center
Colorado Springs, Colorado 80923, United States
Columbus NCI Community Oncology Research Program
Columbus, Colorado 43215, United States
Porter Adventist Hospital
Denver, Colorado 80210, United States
Mercy Medical Center
Durango, Colorado 81301, United States
Southwest Oncology PC
Durango, Colorado 81301, United States
Rocky Mountain Cancer Centers-Lakewood
Lakewood, Colorado 80228, United States
Saint Anthony Hospital
Lakewood, Colorado 80228, United States
Littleton Adventist Hospital
Littleton, Colorado 80122, United States
Longmont United Hospital
Longmont, Colorado 80501, United States
Rocky Mountain Cancer Centers-Longmont
Longmont, Colorado 80501, United States
Parker Adventist Hospital
Parker, Colorado 80138, United States
Saint Mary Corwin Medical Center
Pueblo, Colorado 81004, United States
Rocky Mountain Cancer Centers-Thornton
Thornton, Colorado 80260, United States
Beebe Medical Center
Lewes, Delaware 19958, United States
Delaware Clinical and Laboratory Physicians PA
Newark, Delaware 19713, United States
Helen F Graham Cancer Center
Newark, Delaware 19713, United States
Christiana Care Health System-Christiana Hospital
Newark, Delaware 19718, United States
Holy Cross Hospital
Fort Lauderdale, Florida 33308, United States
Regional Cancer Center-Lee Memorial Health System
Fort Myers, Florida 33905, United States
Carle Cancer Institute Normal
Atlanta, Georgia 30310, United States
Northside Hospital
Atlanta, Georgia 30342, United States
Northside Hospital - Duluth
Duluth, Georgia 30096, United States
Northside Hospital - Gwinnett
Lawrenceville, Georgia 30046, United States
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
Savannah, Georgia 31405, United States
Suburban Hematology Oncology Associates - Snellville
Snellville, Georgia 30078, United States
Island Urology-Hilo
Hilo, Hawaii 96720, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813, United States
Island Urology
Honolulu, Hawaii 96813, United States
Queen's Cancer Cenrer - POB I
Honolulu, Hawaii 96813, United States
Queen's Medical Center
Honolulu, Hawaii 96813, United States
Straub Clinic and Hospital
Honolulu, Hawaii 96813, United States
University of Hawaii Cancer Center
Honolulu, Hawaii 96813, United States
Hawaii Diagnostic Radiology Services LLC
Honolulu, Hawaii 96817, United States
Kuakini Medical Center
Honolulu, Hawaii 96817, United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii 96817, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826, United States
Straub Medical Center - Kahului Clinic
Kahului, Hawaii 96732, United States
Castle Medical Center
Kailua, Hawaii 96734, United States
Wilcox Memorial Hospital and Kauai Medical Clinic
Lihue, Hawaii 96766, United States
Hawaii Cancer Care - Savio
‘Aiea, Hawaii 96701, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii 96701, United States
Pali Momi Medical Center
‘Aiea, Hawaii 96701, United States
Queen's Cancer Center - Pearlridge
‘Aiea, Hawaii 96701, United States
Straub Pearlridge Clinic
‘Aiea, Hawaii 96701, United States
The Cancer Center of Hawaii-Pali Momi
‘Aiea, Hawaii 96701, United States
The Queen's Medical Center - West Oahu
‘Ewa Beach, Hawaii 96706, United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712, United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619, United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642, United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687, United States
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301, United States
OSF Saint Anthony's Health Center
Alton, Illinois 62002, United States
Rush-Copley Medical Center
Aurora, Illinois 60504, United States
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704, United States
Illinois CancerCare-Canton
Canton, Illinois 61520, United States
Memorial Hospital of Carbondale
Carbondale, Illinois 62902, United States
SIH Cancer Institute
Carterville, Illinois 62918, United States
Illinois CancerCare-Carthage
Carthage, Illinois 62321, United States
Centralia Oncology Clinic
Centralia, Illinois 62801, United States
John H Stroger Jr Hospital of Cook County
Chicago, Illinois 60612, United States
Carle on Vermilion
Danville, Illinois 61832, United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526, United States
Decatur Memorial Hospital
Decatur, Illinois 62526, United States
Heartland Cancer Research NCORP
Decatur, Illinois 62526, United States
Illinois CancerCare-Dixon
Dixon, Illinois 61021, United States
Carle Physician Group-Effingham
Effingham, Illinois 62401, United States
Crossroads Cancer Center
Effingham, Illinois 62401, United States
Illinois CancerCare-Eureka
Eureka, Illinois 61530, United States
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401, United States
Western Illinois Cancer Treatment Center
Galesburg, Illinois 61401, United States
Illinois CancerCare-Kewanee Clinic
Kewanee, Illinois 61443, United States
Illinois CancerCare-Macomb
Macomb, Illinois 61455, United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois 62864, United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269, United States
Illinois CancerCare-Ottawa Clinic
Ottawa, Illinois 61350, United States
Illinois CancerCare-Pekin
Pekin, Illinois 61554, United States
Illinois CancerCare-Peoria
Peoria, Illinois 61615, United States

Showing the first 100 of 423 sites across 2 countries.

References and documents

Study documents

Protocol and statistical analysis plan · Nov 21, 2022
Informed consent form · Nov 21, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

Registry details

Key details

Study ID: NCT03475186
Lead sponsor: Wake Forest University Health Sciences
Collaborators: National Cancer Institute (NCI)
Responsible party: Sponsor
First posted: Mar 23, 2018
Start date: Mar 25, 2019
Primary completion: Mar 25, 2025
Completion: Mar 25, 2025
Results posted: Mar 13, 2026
Last update: Mar 13, 2026

Study contacts

Glenn Lesser, MD

principal investigator · Wake Forest University Health Sciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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