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CTRI Number  CTRI/2024/02/062273 [Registered on: 05/02/2024] Trial Registered Prospectively
Last Modified On: 28/02/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Evaluation of Memantin in preservation of neurocognition with craniospinal irradiation. 
Scientific Title of Study   Memantine to preserve memory and neurocognition following craniospinal irradiation (MEMENTO)- A randomised control trial 
Trial Acronym  MEMENTO 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tejpal Gupta 
Designation  Professor, Department of Radiation Oncology 
Affiliation  Tata Memorial Hospital 
Address  Homi Bhabha Block, Ground Floor OPD-056, Tata Memorial Hospital Parel, Mumbai Phone: (022) 2417 6015

Mumbai
MAHARASHTRA
400012
India 
Phone  9821548980  
Fax    
Email  tejpalgupta@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tejpal Gupta 
Designation  Professor, Department of Radiation Oncology 
Affiliation  Tata Memorial Hospital 
Address  Homi Bhabha Block, Ground Floor OPD-056, Tata Memorial Hospital Parel, Mumbai Phone: (022) 2417 6015

Mumbai
MAHARASHTRA
400012
India 
Phone  9821548980  
Fax    
Email  tejpalgupta@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Tejpal Gupta 
Designation  Professor, Department of Radiation Oncology 
Affiliation  Tata Memorial Hospital 
Address  Homi Bhabha Block, Ground Floor OPD-056, Tata Memorial Hospital Parel, Mumbai Phone: (022) 2417 6015

Mumbai
MAHARASHTRA
400012
India 
Phone  9821548980  
Fax    
Email  tejpalgupta@rediffmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Dr E Borges Road, Parel, Mumbai- 400012 
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  HBB, 11TH FLOOR , Tata Memorial Hospital Dr. E Borges Road, Parel, Mumbai - 400 012 India 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tejpal Gupta  Tata Memorial Hospital  Dr E Borges Road, Homi Bhabha ground floor, OPD 056 Parel
Mumbai
MAHARASHTRA 
022-24177000

tejpalgupta@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G938||Other specified disorders of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MEMANTINE- 5mg once daily at bed time for 1 week then 5mg twice daily for 1 week then 10mg twice daily for 6 months  Memantine is an uncompetitive N-Methyl D-Aspartate receptor antagonist and reduces glutamate excitotoxicity. It is FDA-approved for moderate to severe dementia of Alzheimer’s disease and is widely used in the pediatric population for several developmental disorders, including attention-deficit hyperactivity disorder (ADHD), autism, and autism spectrum disorders. Use of Memantine along with cranial irradiation has been proven effective in the preservation of memory and neurocognition. 
Comparator Agent  Standard treatment as planned  Standard treatment as planned without any intervention 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  39.00 Year(s)
Gender  Both 
Details  Planned for CSI, with or without boost dose with or without systemic chemotherapy
Informed consent or assent taken
Karnofsky Performance Status, Lanksy Performance Status≥60 
 
ExclusionCriteria 
Details  Re-irradiation
Prior exposure to memantine
Inability to undergo Wechsler test 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Cognitive-deterioration-free survival   2yrs after accrual 
 
Secondary Outcome  
Outcome  TimePoints 
Overall survival (OS)  at the completion of the study 
Progression free survival (PFS)  until progression at any time point during the study 
 
Target Sample Size   Total Sample Size="101"
Sample Size from India="101" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   22/02/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="7"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Craniospinal irradiation  involving radiation 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. 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 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.

 

 
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