Study of Memantine to Protect Memory and Thinking Skills After Craniospinal Irradiation in Patients Aged 5 to 39

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 Alzheimers 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.

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