NCT04217694

Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors

A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 4 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

This early phase I trial studies the feasibility of giving memantine for the reduction of cognitive impairment after radiation therapy in pediatric patients with central nervous system tumors. Memantine may reduce the effects of radiation therapy on memory and thinking.

Detailed description

PRIMARY OBJECTIVE: I. To evaluate the feasibility of twice daily memantine started before radiation therapy (RT) and one month after RT. SECONDARY OBJECTIVE: I. To evaluate the feasibility of twice daily (BID) memantine started before RT and continued 3 and 6 months after RT. EXPLORATORY OBJECTIVES: I. To evaluate the change in neurocognitive function (NCF) as found by formal neurocognitive testing between baseline and 12 months post-RT. II. To compare the change in NCF between baseline and the end of RT, 3,and 6 months after RT using both neuropsychological testing and the CogState exam. III. To evaluate changes in quantitative volumetric brain imaging using Neuroquant software analysis of magnetic resonance imaging (MRI) imaging before and 12 months after radiation. IV. To correlate cognitive changes detected by CogState composite score and formal neuropsychological testing. V. Disease-free (of primary tumor) and overall survival. OUTLINE: Patients receive memantine orally (PO) BID beginning at the time of study enrollment (no later than 1st day of RT) up to 6 months after completion of standard of care RT in the absence of unacceptable toxicity. Patients also complete CogState cognitive testing at baseline, at completion of RT, and at 3, 6, and 12 months after completion of RT. After completion of study, patients are followed up periodically.

Conditions

• Malignant Central Nervous System Neoplasm
• Primary Central Nervous System Neoplasm

Interventions

Type	Name	Description
BEHAVIORAL	Cogstate Assessment Battery	Complete CogState testing
DRUG	Memantine	Given PO
DRUG	Memantine Hydrochloride	Given PO

Timeline

• Start date: 2020-02-17
• Primary completion: 2022-09-15
• Completion: 2024-08-12
• First posted: 2020-01-03
• Last updated: 2024-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study