A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients After Radiation Therapy for Central Nervous System Tumors
Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
OTHER · Mayo Clinic
OTHER · Mayo Clinic Institutional Review Board
interventional
18
1 country
1
Study Start
February 17, 2020
Actual (reported)Primary Completion
September 15, 2022
Actual (reported)Study Completion
August 12, 2024
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 12, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 23, 2019
Actual (reported)January 3, 2020
Actual (reported)February 17, 2020
Actual (reported)September 15, 2022
Actual (reported)August 12, 2024
Actual (reported)Percentage of patients who attempt to take appropriate dose of memantine
The rate of feasibility (the percentage of patients who attempt to take at least 80% percent of their prescribed dose) will be calculated, along with corresponding 90% confidence intervals.
At 1 month post-radiation therapy (RT)
Percentage of patients who attempt to take appropriate dose of memantine
At 3 and 6 months post-RT
Change in neurocognitive function (NCF)
Baseline up to 12 months post-RT
Change in NCF - CogState
Baseline up to 6 months post-RT
Change in NCF - neuropsychological exam
Baseline up to 6 months post-RT
Patients receive memantine 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.
Complete CogState testing
Given PO
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Nadia N. Laack, M.D.
Mayo Clinic
18 participants (actual enrollment reported by the registry).
First Submitted
December 23, 2019
First Posted
January 3, 2020
Study Start
February 17, 2020
Actual (reported)Brain Imaging Changes Following Proton Therapy for Pediatric Primary Central Nervous System and Base of Skull Tumors
Given PO
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 15, 2022
Actual (reported)Study Completion
August 12, 2024
Actual (reported)Last Updated
November 21, 2024
Record last verified: 2024-11
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: