NCT04939597

A Study to See if Memantine Protects the Brain During Radiation Therapy Treatment for a Brain Tumor

Active, enrolled Phase 3 Last updated 22 December 2025

What this trial tests

Phase 3 trial testing Biospecimen Collection in Central Nervous System Carcinoma in 192 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 May 2022

Primary endpoint
30 June 2026

30 September 2027

Quick facts

Lead sponsor	Children's Oncology Group
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	192
Start date	10 May 2022
Primary completion	30 June 2026
Estimated completion	30 September 2027
Sites	138 locations across Puerto Rico, United States

Drugs / interventions tested

• Biospecimen Collection — full drug profile →
• Cognitive Assessment
• Magnetic Resonance Imaging
• Memantine Hydrochloride — full drug profile →
• Placebo Administration — full drug profile →
• Questionnaire Administration

Conditions studied

• Central Nervous System Carcinoma — all drugs for Central Nervous System Carcinoma →

Sponsor

Children's Oncology Group — full company profile →

Who can join

Adults 4 to 17, any sex, with Central Nervous System Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase III trial compares memantine to placebo in treating patients with primary central nervous system tumors. Memantine may block receptors (parts of nerve cells) in the brain known to contribute to a decline in cognitive function. Giving memantine may make a difference in cognitive function (attention, memory, or other thought processes) in children and adolescents receiving brain radiation therapy to treat a primary central nervous system tumors.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Medulloblastoma in the Modern Era: Review of Contemporary Trials, Molecular Advances, and Updates in Management.
   Lazow MA, Palmer JD, Fouladi M, Salloum R. · · 2022 · cited 28× · PMID 35859223 · DOI 10.1007/s13311-022-01273-0
2. Proton Therapy Mediates Dose Reductions to Brain Structures Associated With Cognition in Children With Medulloblastoma.
   Sienna J, Kahalley LS, Mabbott D, Grosshans D, et al · · 2024 · cited 12× · PMID 38040059 · DOI 10.1016/j.ijrobp.2023.11.035
3. Review: Neurological Complications From Therapies for Pediatric Brain Tumors.
   Nguyen T, Mueller S, Malbari F. · · 2022 · cited 8× · PMID 35480100 · DOI 10.3389/fonc.2022.853034
4. Cancer Neuroscience: Decoding Neural Circuitry in Tumor Evolution for Targeted Therapy.
   Yuan M, Xi R, Kang Y, Kuang MJ, et al · · 2025 · cited 2× · PMID 40926561 · DOI 10.1002/advs.202506813
5. Tumor-infiltrating nerves: unraveling the role of cancer neuroscience in tumorigenesis, disease progression, and emerging therapies.
   Wang X, Fan Y, Wang Q, Shu X, et al · · 2025 · cited 1× · PMID 40591169 · DOI 10.1007/s12672-025-02827-2
6. Metabolic Landscape and Emerging Therapeutic Potential in Pediatric and Adult Gliomas.
   Brock CS, Nguyen L, Pattillo C, Ahamed CJ, et al · · 2026 · PMID 41898581 · DOI 10.3390/ijms27062720
7. Memantine to preserve memory and neurocognition following craniospinal irradiation (MEMENTO): a phase 3 randomized controlled trial.
   Gupta T, Dasgupta A, Goswami S, Chatterjee A, et al · · 2026 · PMID 41673604 · DOI 10.1186/s12885-026-15627-w
8. Characterizing long-term neurocognitive outcomes through diffusion tensor imaging in childhood brain tumor survivors.
   Oglesby RT, Pathiravasan CH, Olatunji E, Chang L, et al · · 2025 · PMID 40119791 · DOI 10.1093/neuonc/noaf083