Memantine and raloxifene to protect memory after brain radiation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial evaluates whether memantine plus raloxifene can reduce cognitive decline in adults receiving radiation therapy for brain tumors. The study targets patients treated with external beam or whole-brain radiation and explores potential neuroprotection from estrogen-modulation alongside memantine. Researchers aim to see if this combination also influences tumor control and molecular changes in CNS cancers. Participants will be monitored for cognitive function, safety, and treatment adherence while receiving the drug regimen. The trial is conducted at UT Health San Antonio, enrolling eligible adults who can provide consent in English or Spanish.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years.
2. Ability to provide informed written consent in either English or Spanish.
3. 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.
4. 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.
5. Patients must have a creatinine clearance ≥ 50 mL/min (using Cockcroft-Gault Equation).
6. Patients must not have hepatic impairment greater than Child-Pugh Score "Class A".

Exclusion Criteria:

1. History of prior radiotherapy to the brain.
2. Life expectancy of \< 6 months.
3. Radiation Therapy planned is ≤ 5 fractions (e.g.stereotactic radiosurgery (SRS)or Steriotactic radiotherapy (SRT), or 5-fraction whole brain).
4. Contraindications to taking memantine and/or raloxifene based on package inserts and the clinical judgement of the treating physician .
5. The subject is unable to undergo magnetic resonance imaging (MRI) scan (e.g., has an MRI incompatible pacemaker).
6. 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.
7. Known allergy to either of the medications (Memantine or Raloxifene) used in this study or their excipients.
8. Cognitive failure as assessed by Mini Mental State Exam (MMSE) score \<17

Where it's running

• Mays Cancer Center, UT Health San Antonio
  San Antonio, Texas, United States Recruiting

Study contacts

• Principal investigator: Andrew J Brenner, MD, PhD — The University of Texas Health Science Center at San Antonio
• Study coordinator: Andrew J Brenner, MD, PhD
• Email: brennera@uthscsa.edu
• Phone: 210-562-4090

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.