Actively Recruiting

Phase 3
Age: 5Years - 39Years
All Genders
ID06275035

Memantine to Preserve Memory and Neurocognition Following Craniospinal Irradiation- A Randomised Controlled Trial (MEMENTO)

Led by Tata Memorial Centre · Updated on 2025-04-09

101

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This trial studies patients aged 5 to 39 years who are receiving craniospinal irradiation (CSI) for medulloblastoma or similar brain and spine tumors. Researchers are evaluating whether adding memantine, a drug approved for Alzheimer's disease, can help preserve memory and cognitive function after radiation therapy. The study compares cognitive outcomes between patients who receive memantine alongside standard treatment and those who receive standard treatment alone. Participants are randomly assigned to one of two groups. The experimental group receives memantine starting at 5 mg once daily for one week, then 5 mg twice daily for another week, and finally 10 mg twice daily for six months. Both groups continue with their planned radiation and chemotherapy schedules. Neurocognitive testing occurs before radiation, at 6 months, 1 year, and yearly up to 5 years after radiation. Standard clinical follow-up visits happen every 3 months for the first 2 years, then every 6 months until 5 years post-radiation. Throughout the study, participants undergo various assessments including neurocognitive tests and evaluations of memory preservation. Researchers monitor cognitive decline and survival outcomes over 2 to 7 years, including intelligence measures and academic performance. Safety is tracked by recording treatment-related side effects. The main outcome is cognitive-deterioration-free survival at 2 years. The total participation duration includes treatment and long-term follow-up visits extending up to 7 years.

CONDITIONS

Brief Title

Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI

Who Can Participate

Age: 5Years - 39Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age at irradiation between 5 and 39 years
  • Planned to receive craniospinal irradiation with or without systemic chemotherapy
  • Informed consent or assent provided
  • Karnofsky or Lansky Performance Status of 60 or higher
Not Eligible

You will not qualify if you...

  • Previous craniospinal re-irradiation
  • Prior exposure to memantine
  • Unable to undergo the Wechsler neurocognitive test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Approximately 6 months

Participants in the experimental arm take memantine with doses gradually increased over 2 weeks to a full dose for 6 months while continuing radiation and chemotherapy as scheduled. Participants in the standard arm receive standard treatment without memantine.

Visits as per radiation and chemotherapy schedule

Follow-up

Duration - Up to 5 years after radiation therapy

After completing treatment, participants undergo regular clinical examinations to monitor health and neurocognitive function.

Every 3 months for 2 years, then every 6 months until 5 years post-radiation

Trial Site Locations

Total: 1 location

1

Tata Memorial Hospital

Mumbai, Maharashtra, India, 400012

Actively Recruiting

Loading map...

Research Team

T

Tejpal Gupta, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

Assessing Neurocognition After Cerebrovascular Intervention

Carotid Artery Diseases

Actively Recruiting

1 location

Microbiome Targeted Oral Butyrate Therapy in Gulf War Multis...

Gulf War Illness

Actively Recruiting

3 locations

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: a randomized, double-blind, placebo-controlled trial.

Paul D Brown, Stephanie Pugh, Nadia N Laack...

https://pubmed.ncbi.nlm.nih.gov/23956241

Hippocampal Avoidance During Whole-Brain Radiotherapy Plus Memantine for Patients With Brain Metastases: Phase III Trial NRG Oncology CC001.

Paul D Brown, Vinai Gondi, Stephanie Pugh...

https://pubmed.ncbi.nlm.nih.gov/32058845