AzTrials
AzTrials

Neurocognitive DysfunctionPhase 3MEMENTONCT06275035

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

A Phase 3 study testing Memantine Oral Tablet in people with Neurocognitive Dysfunction, run by Tata Memorial Centre at 1 site in India.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 5 to 39 years
Conditions the study is for
Neurocognitive Dysfunction
What is being tested?
Memantine Oral Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
101 participants
Where
1 siteIndia
Study dates
22 Feb 2024to Jan 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 39 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

  • Re-irradiation
  • Prior exposure to memantine
  • Inability to undergo Wechsler test

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tejpal Gupta, MD contact

02224177000 ext. 6015

drtejpalgupta@gmail.com

India1 site, 1 recruiting

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

    Dr Tejpal Gupta, MD, 022-24177000 ext. 6015, tejpalgupta@rediffmail.com

    Recruiting

Other trials in India

About this study

Official title: Memantine to Preserve Memory and Neurocognition Following Craniospinal Irradiation- A Randomised Controlled Trial (MEMENTO)

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.

Read the detailed 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.

Being tested
Memantine Oral Tablet
Medical subject headings
Cognition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Memantine Oral TabletDrug

    Also called Memantine

    Drug to preserve memory and neurocognitive dysfunction induced by radiation therapy

Study groups in NCT06275035
Study groupRoleWhat they receive
Experimental armExperimentalParticipants in the experimental arm (memantine) will be started on memantine. The starting dose of memantine 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.
Receives: Drug: Memantine Oral Tablet
Standard armNo interventionParticipants in the standard arm will continue the standard treatment as planned.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive-deterioration-free survival at 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).

    Measured: 2 years

Secondary outcomes (6)

  1. Full-Scale Intelligence Quotient (FSIQ) in children

    The slope of decline of FSIQ with time as measured using age-appropriate neurocognitive test battery for children (Wechsler Intelligence Scale for Children- WISC)

    Measured: 7 years

  2. Overall survival (OS)

    Comparison of survival outcomes in both the arms

    Measured: 7 years

  3. Academic performance by scholastic performance and grades

    Comparison of scholastic performance as graded in school examinations in pediatric participants in both arms

    Measured: 7 years

  4. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of Memantine

    Recording of any unexpected adverse drug reactions according to CTCAE v 5.0

    Measured: 2 years

  5. Progression-Free Survival (PFS)

    Comparison of progression-free survival time in both arms

    Measured: 7 years

  6. Full-Scale Intelligence Quotient (FSIQ) in adults

    The slope of decline of FSIQ with time as measured using age-appropriate neurocognitive test battery for adults (Wechsler Adult Intelligence Scale-WAIS)

    Measured: 7 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2024
  2. Study start22 Feb 2024
  3. Primary completionJan 2026 (estimated)
  4. Study completionJan 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
101 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06275035
Sponsor's protocol ID
4235
Acronym
MEMENTO
Status last verified
Apr 2025
First submitted
17 Jan 2024
Last updated
9 Apr 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data from the study will not be shared publicly but anonymized data can be made available upon reasonable request to the Principal Investigator

Publications

  • Brown PD, Pugh S, Laack NN, Wefel JS, Khuntia D, Meyers C, Choucair A, Fox S, Suh JH, Roberge D, Kavadi V, Bentzen SM, Mehta MP, Watkins-Bruner D; Radiation Therapy Oncology Group (RTOG). Memantine for the prevention of cognitive dysfunction in patients receiving whole-brain radiotherapy: a randomized, double-blind, placebo-controlled trial. Neuro Oncol. 2013 Oct;15(10):1429-37. doi: 10.1093/neuonc/not114. Epub 2013 Aug 16.

    PubMed 23956241

  • Brown PD, Gondi V, Pugh S, Tome WA, Wefel JS, Armstrong TS, Bovi JA, Robinson C, Konski A, Khuntia D, Grosshans D, Benzinger TLS, Bruner D, Gilbert MR, Roberge D, Kundapur V, Devisetty K, Shah S, Usuki K, Anderson BM, Stea B, Yoon H, Li J, Laack NN, Kruser TJ, Chmura SJ, Shi W, Deshmukh S, Mehta MP, Kachnic LA; for NRG Oncology. Hippocampal Avoidance During Whole-Brain Radiotherapy Plus Memantine for Patients With Brain Metastases: Phase III Trial NRG Oncology CC001. J Clin Oncol. 2020 Apr 1;38(10):1019-1029. doi: 10.1200/JCO.19.02767. Epub 2020 Feb 14.

    PubMed 32058845

  • Gupta T, Dasgupta A, Goswami S, Chatterjee A, Dhingra S, Deodhar J, Sonkusare L, Prasad M, Gollamudi VRM, Kannan S, Vishwakarma K, Menon N, Moiyadi A, Shetty P, Singh V, Epari S, Sahay A, Shah A, Sahu A, Choudhari A, Bhattacharya K, Bano N, Gupta N, Chinnaswamy G. Memantine to preserve memory and neurocognition following craniospinal irradiation (MEMENTO): a phase 3 randomized controlled trial. BMC Cancer. 2026 Feb 11;26(1):365. doi: 10.1186/s12885-026-15627-w.

    PubMed 41673604

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Memantine Oral Tablet in people with Neurocognitive Dysfunction, run by Tata Memorial Centre at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tejpal Gupta, MD (02224177000 ext. 6015, drtejpalgupta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive-deterioration-free survival at 2 years (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06275035, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in