Evaluation of Memantine in the Preservation of Memory and Neurocognition Following CSI
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 t
| Condition(s) | Neurocognitive Dysfunction |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 |
| Ages | 5 Years to 39 Years |
| Sex | All |
| Lead sponsor | Tata Memorial Centre |
| Locations | Mumbai, Maharashtra, India |
| Start date | 2024-02-22 |
| NCT ID | NCT06275035 |
| Official listing | https://clinicaltrials.gov/study/NCT06275035 |