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Recruiting Phase 3

Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI

NCT06275035 · tracked via the Priya Life Science India tracker
Phase
Phase 3
Started
2024-02-22
Last updated
2025-04-09

Condition(s) studied

Neurocognitive Dysfunction

Investigational drug(s) / intervention(s)

Memantine Oral Tablet →

Memantine Oral Tablet: Drug to preserve memory and neurocognitive dysfunction induced by radiation therapy

Study summary

The goal of this clinical trial is to evaluate the role of memantine in preservation of memory and neurocognition in patients undergoing craniospinal irradiation. Participants will be randomised into two arms and the interventional arm will receive memantine along with the standard treatment. Researchers will compare the neurocognitive tests of participants in both the arms to see if memantine leads to significant preservation of memory and cognition post radiation therapy.

Eligibility

Sex
ALL
Min age
5 Years
Max age
39 Years
Healthy volunteers
No
Inclusion Criteria: * Age at irradiation: 5 to 39 years * Planned for CSI (with or without boost dose) with or without systemic chemotherapy * Informed consent or assent taken * Karnofsky Performance Status / Lansky Performance Status ≥ 60 Exclusion Criteria: * Re-irradiation * Prior exposure to memantine * Inability to undergo Wechsler test

Primary outcome measure(s)

  • Cognitive-deterioration-free survival at 2 years — 2 years
    Cognitive-deterioration-free survival at 2 years; defined by a drop of 5 points in any of Full Scale Intelligence Quotient (FSIQ), Verbal Intelligence Quotient (VIQ), or Performance Intelligence Quotient (PIQ) compared to baseline (pre-radiation) on Wechsler Adult Intelligence Scale (WAIS), and Wechsler Intelligence Scale for Children (WISC).

Trial sites (1)

FacilityCityRegionStatus
Tata Memorial Hospital Mumbai Maharashtra Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06275035 on ClinicalTrials.gov ↗ ← All trials in India