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/23956241Actively Recruiting
Led by Tata Memorial Centre · Updated on 2025-04-09
101
Participants Needed
1
Research Sites
260 weeks
Total Duration
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
Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Total: 1 location
1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
Actively Recruiting
T
Tejpal Gupta, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Paul D Brown, Stephanie Pugh, Nadia N Laack...
https://pubmed.ncbi.nlm.nih.gov/23956241Paul D Brown, Vinai Gondi, Stephanie Pugh...
https://pubmed.ncbi.nlm.nih.gov/32058845