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
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.
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).
2,132 studies on the registry are indexed under Glioblastoma; 464 are open to participants now.
This study's enrollment of 75 is above the median of 36 across 1,753 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patient must be able to complete neurocognitive tests in the English language
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
2.5 - 5 mg oral, 1x daily for 22 weeks
Also known as: Altace, Tritace
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
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
| 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 |
| Milestone | Ramipril |
|---|---|
| Started | 61 |
| Completed | 56 |
| Not completed | 5 |
| Withdrew: Hospice | 3 |
| Withdrew: Disease progression | 1 |
| Withdrew: Other | 1 |
| 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 |
| Milestone | Ramipril |
|---|---|
| Started | 46 |
| Completed | 43 |
| Not completed | 3 |
| Withdrew: Death | 2 |
| Withdrew: Overwhelmed | 1 |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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.
| 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) |
Measured by the percent of patients who took 75% of the Ramipril doses and completed the neurocognitive battery of tests
| Percentage of participants | Ramipril |
|---|---|
| Retention Rate at 10 Weeks | 48 (38 to 100) |
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.
| 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) |
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.
| 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) |
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.
| 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) |
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.
| 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) |
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.
| 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) |
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.
| 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) |
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.
| Participants | Ramipril |
|---|---|
| Week 6 | 9 |
| Week 10 | 10 |
| Week 22 | 11 |
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.
| Participants | Ramipril |
|---|---|
| Week 6 | 14 |
| Week 10 | 8 |
| Week 22 | 6 |
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.
| Participants | Ramipril |
|---|---|
| Week 6 | 21 |
| Week 10 | 13 |
| Week 22 | 13 |
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.
| Participants | Ramipril |
|---|---|
| Week 6 | 10 |
| Week 10 | 12 |
| Week 22 | 8 |
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.
| Participants | Ramipril |
|---|---|
| Week 6 | 13 |
| Week 10 | 14 |
| Week 22 | 9 |
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.
| Participants | Ramipril |
|---|---|
| Week 6 | 3 |
| Week 10 | 3 |
| Week 22 | 3 |
Measured by quantitative polymerase chain reaction (PCR) using patient serum via a blood test
No measurements were reported for this outcome.
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
Collected over Enrollment to 26 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ramipril | 2/75 (2.7%) | 8/75 (10.7%) | 31/75 (41.3%) |
| 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 |
| 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 |
| Age, Continuous(years) | Ramipril |
|---|---|
| Median | 63 (55 to 70) |
| Sex: Female, Male(Participants) | Ramipril |
|---|---|
| Female | 26 |
| Male | 49 |
| Ethnicity (NIH/OMB)(Participants) | Ramipril |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 72 |
| Unknown or Not Reported | 0 |
| 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(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(count) | Ramipril |
|---|---|
| Mean | 0.76 ± 1.67 |
| 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(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.
Showing the first 100 of 423 sites across 2 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
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.
Time frame: 6 months after publication for a 2 year duration
Access criteria: upon request to NCORP@wakehealth.edu
Ran from Mar 2019 to primary completion in Mar 2025, 72 months.
Results were first posted in Mar 2026, 11 months after primary completion.
Of 198 non-industry phase 2 interventional studies under Glioblastoma, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 41 and three quarters within 89. This study's 72 months is above that.
Counting every sponsor, half of 249 studies reached it within 56 months; a quarter within 40 and three quarters within 87.
How these figures are worked out, and which studies are left out of them.
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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Studies of the drug tested here: Ramipril
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