A Phase 2 interventional study of Memantine and Raloxifene in Brain Tumor, sponsored by The University of Texas Health Science Center at San Antonio. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 2, Interventional, and Treatment
The study investigators are testing to see if patients receiving radiation treatment for brain cancer along with raloxifene plus memantidine take longer to develop memory issues.
The study will include anyone over the age of 18 who will be treated with radiation for brain cancer.
As cognitive decline is a common side effect after external beam radiation therapy to the brain, estrogen receptor beta (ERβ) modulation presents an unexploited target for mitigating this adverse effect as well.
The investigators seek to address two scientific questions to improve quality of life in patients and improve cancer outcomes: 1) can estrogen modulation further augment neuroprotection achieved by memantine after radiation therapy to the brain? and 2) can estrogen modulation lead to measurable tumor control improvement and molecular changes in CNS malignancies?
2,440 studies on the registry are indexed under Brain Neoplasms; 540 are open to participants now.
This study's planned enrollment of 108 is above the median of 40 across 1,831 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 445 studies on the registry; 89 are open to participants now.
Of its 65 completed or terminated interventional studies of FDA-regulated products, 35 (54%) 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.
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.
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.
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.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
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.
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.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks.
Drug: Memantine
Patients will start Memantine as SOC around the time of radiation. Memantine may be continued as SOC as prescribed by the treating physician after the 24 weeks. If randomized to group B patients will be recommended to start the assigned Raloxifene at least one week before their anticipated RT treatment start date.
Drug: Memantine · Drug: Raloxifene
The goal dose for Immediate Release Memantine is 10 mg oral twice daily. The goal-dose for Extended-Release Memantine is 21 mg daily.
Also known as: Namenda
Raloxifene will be administered at 120mg orally every day
Also known as: Evista
Hippocampal volume changes
MRIs will be used to capture any changes in hippocampal volume
Time frame: Baseline to 48 weeks
Eastern Cooperative Oncology Group Performance Status score
A 0-5 scale to assess a cancer patient's functional ability showing how their daily life is impacted by the disease. A score of 0 means fully active, while a higher score indicates increasing disability with 5 indicating death.
Time frame: Baseline to study termination visit (approximately 48 weeks)
Hopkins Verbal Learning Test Revised (HLVT-R) Score
HVLT-R scoring involves summing words recalled in learning trials for Total Recall, calculating Percentage Retention (Delayed Recall / Higher of Trials 2/3), and determining the Recognition Discrimination Index (True Positives - False Positives). These raw scores are then converted to age-adjusted T-scores, which are compared to normative data (16-92 years old) to assess verbal learning and memory in brain-disordered populations, with higher scores generally indicating better performance.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Trail Making Test -A (TMT-A) Score
A neuropsychological number test measuring psychomotor speed and visual attention by connecting numbers (1-25) in sequence. Higher scores (more time) indicate greater impairment, with averages around 29 seconds, while scores over 30-40 seconds often suggest potential cognitive issues, though norms vary by age and education.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Trail Making Test -B (TMT-B) Score
A neuropsychological number and letter test measuring psychomotor speed and visual attention by connecting numbers (1-25) in sequence. Higher scores (more time) indicate greater impairment, with averages around 75 seconds, while scores over 273 second often suggest potential cognitive issues, though norms vary by age and education.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Controlled Oral Word Association (COWA) Test Score
A neuropsychological test assessing verbal fluency and executive functions like self-initiation, requiring a person to name as many words as possible starting with a specific letter (like F, A, S, or C, F, L) within 60 seconds, for three trials, while avoiding repetitions, proper nouns, or variations of the same word root to gauge cognitive health, especially after brain injury or with conditions like dementia. The score includes the total number of unique, correct words across the trials. A higher score indicated better cognitive function.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) Brain (BN)tumor-20
A 20 item questionnaire with each item scored from 0-4 with a total possible score of 0-80. A higher score indicates a worse quality of life.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
MD Anderson Symptom Inventory Brain Tumor (MDASI-BT)
Involves rating 23 symptoms and 6 interference items on a 0-10 scale (0=not present/did not interfere, 10=as bad as you can imagine/interfered completely) for the last 24 hours, calculating mean scores for overall symptoms, symptom factors (like neurological, cognitive, GI), and interference (activity/mood), with scores of 5 or greater indicating moderate-to-severe symptoms. Scores are averaged for summary measures, providing a picture of symptom burden and its impact on daily life for brain tumor patients. A mean of the total score is calculated with a higher score indicating worse symptoms.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Functional Assessment of Cancer Therapy - Brain (FACT-Br)
A total of 50 items are included that cover the following domains of Quality of life (QOL): physical well-being, social/family well-being, emotional well-being, functional well-being, and disease specific concerns. Patients are asked to indicate the presence/severity of certain issues/symptoms on a scale of 0 - 4 (a 5-point Likert Scale).The range of scores is 0-148 with a higher indicating a better quality of life.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Medical Outcomes Study - Cognitive Function (MOS-CF)
The Medical Outcomes Study Cognitive Functioning Scale is a patient-reported measure of perceived cognitive functioning consisting of six items that assess the frequency of problems with concentration, reasoning, confusion, forgetfulness, and mental clarity during the previous four weeks. Each item is scored on a 6-point Likert scale ranging from 1 ("all of the time") to 6 ("none of the time"), where higher values indicate fewer cognitive difficulties. Item scores are summed to generate a raw total score ranging from 6 to 36, with higher scores reflecting better cognitive functioning and fewer reported cognitive problems, and lower scores indicating greater perceived impairment. In some studies the raw score is also linearly transformed to a 0-100 scale, where 0 represents the worst cognitive functioning and 100 represents the best cognitive functioning.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Patient Reported Outcomes Measurement Information System - Cognitive Function (PROMIS-CF)
The PROMIS-CF score is derived from two items: (1) My memory has been as good as usual and (2) I have been able to focus my attention, which ask patients to self-report on their cognitive abilities with the following response scale: 1 = Not at all, 2 = A little bit, 3 = Somewhat; 4 = Quite a bit, and 5 = Very much. Total scores are from 1-10 with a higher score indicating better cognitive function.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Hopkins Verbal Learning Test Revised HLVT-R DR
Hopkins Verbal Learning Test-Revised Delayed Recall is a neuropsychological test assessing verbal memory by having individuals recall a list of 12 words after a delay (around 20-25 minutes). Scoring is from 0-12 with a higher score indicating better recall.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Hopkins Verbal Learning Test Revised HLVT-R RECOG
The Hopkins Verbal Learning Test-Revised recognition discrimination index is a component of the HVLT-R that evaluates verbal recognition memory following presentation of a 12-word learning list. After the delayed recall phase, participants complete a recognition trial consisting of 24 items (the 12 original target words mixed with 12 distractor words). For each item, the respondent indicates whether the word was part of the original list (yes/no). Scoring is based on the Recognition Discrimination Index (RDI), calculated as the number of correct recognitions (hits) minus the number of incorrect endorsements of distractors (false positives). The resulting score ranges from -12 to +12, with higher scores indicating better recognition memory and greater ability to discriminate target words from distractors, while lower scores reflect poorer recognition performance and greater memory impairment.
Time frame: Week 0 to study termination visit (approximately 48 weeks)
Plan to share: Yes — Individual participant data may be shared with groups involved in overseeing this research study including monitors, data safety monitoring committee, any law enforcement agencies, the IRB or any state or local health departments. Any de-identified results will be submitted for publication in a peer reviewed journal.
Supporting information: Study protocol, Statistical analysis plan
Time frame: IPD will be shared at study completion after the data analysis is complete and the publication is accepted in a peer review journal
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jul 2030, 48 months after the start.
Of 208 non-industry phase 2 interventional studies under Brain Neoplasms, half reached primary completion within 67 months of starting (the median), counting those still running; a quarter within 43 and three quarters within 100. This study's planned 48 months is below that.
Counting every sponsor, half of 252 studies reached it within 61 months; a quarter within 38 and three quarters within 98.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Raloxifene
The University of Texas Health Science Center at San Antonio →