Clinical trial · Interventional
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
NCT04217694CI-TRIAL-00082829completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Central Nervous System Neoplasm | Malignant Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Primary Central Nervous System Neoplasm | Primary Central Nervous System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cogstate Assessment Battery | Behavioral | — | UNRESOLVED |
| Memantine | Drug | — | UNRESOLVED |
| Memantine Hydrochloride | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prevention (memantine, CogState)
- description
- 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.
- interventionNames
- Behavioral: Cogstate Assessment Battery
- Drug: Memantine
- Drug: Memantine Hydrochloride
Primary outcomes (1)
- measure
- Percentage of patients who attempt to take appropriate dose of memantine
- timeFrame
- At 1 month post-radiation therapy (RT)
- description
- 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.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 4 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Receiving intracranial radiation for a primary central nervous system (CNS) malignancy * Histological or radiologic confirmation of intracranial disease * Able to use the computer for CogState assessment battery * Normal serum creatinine per institutional normal limits (obtained =\< 35 days prior to study entry) * Total bilirubin =\< 1.5 x upper limit of normal (ULN) OR direct bilirubin =\< ULN for patients with total bilirubin levels \> 1.5 x ULN (obtained =\< 35 days prior to study entry) * Aspartate transaminase (AST) AND alanine transaminase (ALT) =\< 2.5 x ULN * Provide informed consent if over age 18, or provide assent with consent from parent or legal guardian if age 7-17 * Negative pregnancy test done =\< 7 days prior to registration, for women of childbearing potential only. Patients capable of childbearing must use adequate contraception Exclusion Criteria: * Patients with World Health Organization (WHO) grade IV astrocytoma or glioblastoma tumors * Note: A patient with grade IV tumors of other histology can participate in the study if they meet all other criteria * Any prior intracranial radiation * Any contraindication or allergy to memantine * Use of short-acting benzodiazepines (may excite lethargy/dizziness with memantine) * Note: occasional use as a sleep aid or as needed for anxiety or nausea is allowed * Intractable seizures while on adequate anticonvulsant therapy, defined as more than one seizure per month for the past 2 months * Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
References
Publications (0)
Data not yet available
No reference posted for this study.