Memantine +/- Raloxifene for Brain Tumor

(MemoryRT Trial)

AJ
EM
Overseen ByEva M Galvan, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: The University of Texas Health Science Center at San Antonio
Must be taking: Raloxifene, Memantine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding raloxifene (a medication typically used for osteoporosis) to memantine (a drug for memory loss) can delay memory problems in patients undergoing radiation treatment for brain cancer. Participants will be divided into two groups: one will receive standard memantine treatment, while the other will receive both memantine and raloxifene. The study seeks adults about to start radiation therapy for a brain tumor. Candidates should not have had previous brain radiation and must be able to undergo an MRI.

As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to significant advancements in brain cancer care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that memantine is safe for patients. It is already used to treat conditions like Alzheimer’s disease, demonstrating a strong safety record. Most reported side effects are mild, such as dizziness or headache.

Raloxifene has also undergone study for its effects on the brain. Research shows it may help protect against brain damage and could reduce the risk of mild memory problems by 33% in postmenopausal women. However, it may increase the risk of stroke, so discussing concerns with a doctor is important.

Both treatments have been used in other contexts, providing researchers with a good understanding of their safety. Always discuss potential risks and benefits with a healthcare provider.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because Memantine, typically used to manage symptoms of Alzheimer's, is being explored for its potential to protect brain cells during radiation therapy for brain tumors. This is intriguing because it could help reduce cognitive side effects often associated with radiation. Additionally, Raloxifene, commonly used in osteoporosis, is being examined for its ability to impact tumor growth by modulating estrogen receptors. The combination of these two drugs could offer a unique approach, potentially enhancing the effectiveness of standard care while minimizing negative side effects on brain function.

What evidence suggests that this trial's treatments could be effective for brain cancer?

Studies have shown that memantine can protect memory in patients receiving radiation for brain cancer by blocking certain overly active brain receptors. In this trial, participants in Group A will receive memantine as part of the standard care. Research also suggests that raloxifene, another drug tested in this trial, might protect brain cells by reducing harmful stress in the brain and possibly improving brain function. Participants in Group B will receive both memantine and raloxifene. Although more information is needed, these findings suggest that combining raloxifene with memantine might better protect memory during cancer treatment.14678

Are You a Good Fit for This Trial?

This trial is for adults (18+) with brain tumors who are about to receive radiation therapy. Participants must have good kidney and liver function, be able to consent, not be pregnant, and agree to use birth control if needed. People can't join if they have severe cognitive problems, prior brain radiation, or allergies to the study drugs.

Inclusion Criteria

Creatinine clearance ≥ 50 mL/min
Willingness to adhere to planned study drug regimen
I am receiving radiation therapy to my brain for solid tumor cancer.
See 4 more

Exclusion Criteria

Known allergy to medications used in the study or their excipients
Life expectancy of less than 6 months
Inability to undergo MRI scan
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive radiation therapy to the brain, with memantine as standard of care, and raloxifene for Group B

6 weeks
Weekly visits for radiation sessions

Treatment

Participants continue memantine treatment, with Group B also receiving raloxifene

24 weeks

Follow-up

Participants are monitored for cognitive function and quality of life outcomes

18 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Memantine
  • Raloxifene

Trial Overview

The study tests whether adding raloxifene to memantine helps protect memory in people getting brain radiation for cancer. Participants will get either memantine alone or both drugs during their treatment.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Group B: Standard of Care plus raloxifeneExperimental Treatment2 Interventions
Group II: Group A: Standard of CareActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials
486
Recruited
92,500+

Citations

Association of raloxifene and tamoxifen therapy with cognitive ...

Our results demonstrate that the use of these medications was not associated with global or domain‐specific cognition, odds of MCI, or structural MRI markers ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/33203845/

Raloxifene prevents stress granule dissolution, impairs ...

Raloxifene prevents stress granule dissolution, impairs translational control and promotes cell death during hypoxia in glioblastoma cells.

Raloxifene as Treatment for Various Types of Brain Injuries ...

Recent studies have shown that the selective estrogen receptor modulator (SERM) raloxifene had pronounced protective effects against progressing brain ...

(PDF) Association of raloxifene and tamoxifen therapy with ...

Association of raloxifene and tamoxifen therapy with cognitive performance, odds of mild cognitive impairment, and brain MRI markers of ...

Raloxifene exposure enhances brain activation during ...

When compared to placebo, raloxifene treatment significantly enhanced activation in these structures (Z > 3.1), except for mediotemporal areas. Task performance ...

Raloxifene as Treatment for Various Types of Brain Injuries ...

Recent studies have shown that the selective estrogen receptor modulator (SERM) raloxifene had pronounced protective effects against progressing brain damage ...

Neuroprotective Potential of Raloxifene via G-Protein- ...

Our findings suggest that raloxifene safeguards against Aβo-induced neurotoxicity by modifying oxidative parameters and maintaining [Ca2+]i homeostasis.

Effect of Raloxifene on Prevention of Dementia and ...

Raloxifene, at a dose of 120 mg/day, reduced the risk of developing mild cognitive impairment by 33% among postmenopausal women with ...