Memantine +/- Raloxifene for Cognitive Preservation After Radiation Therapy to the Brain

NCT07470606 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CTMS# 25-0146
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Brain Tumor

Keywords

Radiation therapy; Solid tumor cancer; Intensity modulated radiation therapy (IMRT)

Outcome Measures

Primary Outcomes (1)

• Hippocampal volume changes

  MRIs will be used to capture any changes in hippocampal volume

  Baseline to 48 weeks

Secondary Outcomes (12)

• Eastern Cooperative Oncology Group Performance Status score

  Baseline to study termination visit (approximately 48 weeks)

• Hopkins Verbal Learning Test Revised (HLVT-R) Score

  Week 0 to study termination visit (approximately 48 weeks)

• Trail Making Test -A (TMT-A) Score

  Week 0 to study termination visit (approximately 48 weeks)

• Trail Making Test -B (TMT-B) Score

  Week 0 to study termination visit (approximately 48 weeks)

• Controlled Oral Word Association (COWA) Test Score

  Week 0 to study termination visit (approximately 48 weeks)

Study Arms (2)

Group A: Standard of Care

ACTIVE COMPARATOR

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

Group B: Standard of Care plus raloxifene

EXPERIMENTAL

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

Interventions

Memantine DRUG

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

Group A: Standard of Care; Group B: Standard of Care plus raloxifene

Raloxifene DRUG

Raloxifene will be administered at 120mg orally every day

Also known as: Evista

Group B: Standard of Care plus raloxifene

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Ability to provide informed written consent in either English or Spanish.
• All individuals of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use of barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an Intrauterine device (IUD)) with their partner from entry into the study through 24 weeks after the last dose of Raloxifene.
• Patients undergoing radiation therapy to the brain as a part of solid tumor cancer therapy, using intensity modulated radiation therapy (IMRT) or whole brain radiation therapy (WBRT).Willingness to adhere to planned study drug regimen, including obtaining medication from an outside pharmacy via prescription.
• Patients must have a creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault Equation).
• Patients must not have hepatic impairment greater than Child-Pugh Score "Class A".

You may not qualify if:

• History of prior radiotherapy to the brain.
• Life expectancy of \< 6 months.
• Radiation Therapy planned is ≤ 5 fractions (e.g.stereotactic radiosurgery (SRS)or Steriotactic radiotherapy (SRT), or 5-fraction whole brain).
• Contraindications to taking memantine and/or raloxifene based on package inserts and the clinical judgement of the treating physician .
• The subject is unable to undergo magnetic resonance imaging (MRI) scan (e.g., has an MRI incompatible pacemaker).
• Conditions or situations which, in the opinion of the investigator, imply the patient will be unable or not suitable to complete trial requirements or at excessive risk from trial participation.
• Known allergy to either of the medications (Memantine or Raloxifene) used in this study or their excipients.
• Cognitive failure as assessed by Mini Mental State Exam (MMSE) score \<17

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

Mays Cancer Center, UT Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Memantine; Raloxifene Hydrochloride

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Tamoxifen; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic

Central Study Contacts

Andrew J Brenner, MD, PhD

CONTACT

210-562-4090; brennera@uthscsa.edu

Eva M Galvan, MD

CONTACT

210-450-1093; GalvanE@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a Single-Institution, Open-Label, Prospective, 2-Group (R+M, M) Randomized Phase 2 Study

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 13, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2031
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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

Locations

US (1)