Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

Craniospinal irradiation (CSI) involving radiation (RT) of brain and spine, along with tumor-bed boost with or without chemotherapy, is the current standard treatment for medulloblastoma and other primitive embryonal tumors of the central nervous system (CNS). The delayed side effects following CSI include memory loss, hearing and balance difficulties, hormonal imbalance, and secondary cancers. Decline in memory severely affects the quality of life in long term survivors of these diseases. Hence, various strategies are being tried to prevent it. Memantine has been proven to effectively prevent the memory decline induced by RT. It is FDA-approved for Alzheimer's disease and is widely used in the children for several developmental disorders. With this study, we are trying to investigate the role of memantine in patients receiving CSI to prevent memory decline. After screening for the study, eligible patients will be randomly allocated (by computerised system) to one of the two arms that are described as follows. Patients in the experimental arm (memantine) will be started on memantine, starting dose of the same will be 5mg once daily at bedtime for 1 week, followed by 5mg twice daily for 1 week, and finally increased to the full dose of 10 mg twice daily for 6 months. Patients will continue on radiation and chemotherapy (when indicated) as per schedule. All patients in the study will undergo neurocognitive evaluation, the time points for which will be pre-radiation (baseline), 6 months post-RT, 1-year post-RT, and annually after that for 5 years from radiation. Following completion of RT or treatment, standard follow-up protocols will include a clinical examination 3 monthly for the first 2 years, followed by 6 monthly visits till 5 years post-RT. No additional risk is expected from the current study other than the common side effects of the standard treatment. Based on the results from the study, if primary endpoints are achieved, it will establish the role of memantine in preventing memory decline from CSI, which can be used as a standard treatment measure to help patients in the future. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06275035
Study type Interventional
Source Tata Memorial Centre
Contact Tejpal Gupta, MD
Phone 02224177000
Email drtejpalgupta@gmail.com
Status Recruiting
Phase Phase 3
Start date February 22, 2024
Completion date January 2031

See also
  Status Clinical Trial Phase
Completed NCT04005456 - Personalized Lifestyle Intervention for Improving Functional Health Outcomes Using N-of-1 Tent-Umbrella-Bucket Design N/A
Enrolling by invitation NCT06227962 - Cognitive Functioning and Health Related Quality of Life in Retinoblastoma Survivors
Completed NCT04038788 - Add-on HD Hf-tRNS Over Bilateral DLPFC for Treating Patients With Schizophrenia N/A
Withdrawn NCT01186289 - Statin Therapy To Limit Cognitive Dysfunction After Cardiac Surgery N/A
Recruiting NCT05077748 - An 18-year Follow-up Study on OSA in a Population-based Cohort
Recruiting NCT03709199 - Long Term Follow up of Children Enrolled in the REDvent Study
Recruiting NCT03606421 - CBF and NCF Changes With Brain Radiation
Recruiting NCT04458207 - Cognitive Changes and Neural Correlates After Rehabilitation of Masticatory Function in Elderly -an Intervention Study N/A
Recruiting NCT05363332 - Impact and Sequelae of High Ventilatory Drive in Critically Ill COVID-19 Patients
Recruiting NCT03886675 - Intervention With Cerebral Embolic Protection in TEVAR: Gaseous Protection N/A
Enrolling by invitation NCT04373525 - Prospective Evaluation on Cognitive Function and Its Associated Genetic Vulnerability in Cannabis Users
Enrolling by invitation NCT04881266 - Long-Term Functional, Quality-of-Life, Neuropsychological and Cognitive Outcomes in COVID-19 Critical Illness Survivors
Completed NCT03795454 - Can Singing Kangaroo Improve Outcome of Preterm Infants N/A
Recruiting NCT05019300 - Long-term Neurocognitive and Psychiatric Consequences in Severe COVID-19 Survivors.
Not yet recruiting NCT05245903 - Passive Sensor Identification of Digital Biomarkers to Assess Effects of Orally Administered Nicotinamide Riboside
Terminated NCT03163277 - Using Less Neurotoxic Drugs in Patients With HAND (MARAND-X) Phase 4
Not yet recruiting NCT06224088 - Neuro-cognitive Function 1 Year Post ICU Discharge Among VV ECMO Survivors
Completed NCT03460821 - Validation of a German Translation and Cultural Adaptation of the Addenbrooke's Cognitive Examination III
Not yet recruiting NCT06413173 - Remotely Supervised tDCS+ for Complex Attention in mTBI (Cognetric) N/A
Terminated NCT03863639 - Changes in fMRI and Neurocognitive Function in Women With Pre-eclampsia