| 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
|
|
|
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
|
|
|
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. |