Memantine for the Reduction of Cognitive Impairment After Radiation Therapy in Pediatric Patients With Central Nervous System Tumors
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- STATUS
- Recruiting
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- participants needed
- 20
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- sponsor
- Mayo Clinic
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.
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.
Details
| Condition | Malignant Central Nervous System Neoplasm, Primary Central Nervous System Neoplasm |
|---|---|
| Age | 4-18 years |
| Treatment | Cogstate Assessment Battery, Memantine, Memantine Hydrochloride |
| Clinical Study Identifier | NCT04217694 |
| Sponsor | Mayo Clinic |
| Last Modified on | 19 February 2024 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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