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

ConditionNeurocognitive Dysfunction

Trial statusRecruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age5-39

SponsorTata Memorial Centre

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Re-irradiation

Prior exposure to memantine

Inability to undergo Wechsler test

Trial design

Design model

Parallel

Treatments tested in this trial

Memantine Oral Tablet
Drug
Drug to preserve memory and neurocognitive dysfunction induced by radiation therapy

Treatment groups

101 Participants

are divided into 2 treatment groups

Group A: Experimental armExperimental treatment 1 intervention

Group B: Standard armNo intervention 0 interventions

Trial outcomes

Primary outcomes

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).

Time frame

2 years

Secondary outcomes

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)

Time frame

7 years

Overall survival (OS)

Comparison of survival outcomes in both the arms

Time frame

7 years

Academic performance by scholastic performance and grades

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

Time frame

7 years

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

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

Time frame

2 years

Other outcomes

Full Scale Intelligence Quotient change in subgroups

Subgroup analysis of FSIQ slope. Subgroup stratification based on age, prior treatment of chemotherapy, dose of radiation received

Time frame

7 years

Radiological features of cognitive decline on Magnetic Resonance Imaging

Fractional decline in volume of anatomical structures like hippocampus with radiation and correlation with FSIQ using Pearson correlation.

Time frame

7 years

Neuroinflammatory markers correlation with neurocognitive decline and survival

Neuro-inflammatory markers in Cerebrospinal Fluid (CSF), blood and its correlation with Full-Scale Intelligence Quotient scores. List of markers to be measured:- * Inflammatory panel using ELISA: Interleukin(IL)- 6, IL-1, IL-4, IL-8, IL-10, IL-11, IL-12, Tumor Necrosis Factor- alpha, Interferon- gamma, Granulocyte macrophage colony-stimulating factor, Chitinase-3-like protein 1, Transforming Growth Factor- beta, C- reactive protein, Glial Fibrillary Acidic Protein, Ubiquitin, Carboxy- terminal hydrolase L1 * Cell free Deoxyribo Nucleic Acid- using MagMax cell free DNA isolation kit * Circulating cancer cells using cell search circulating tumor cell kit

Time frame

7 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tata Memorial Centre

Lead sponsor

Source ClinicalTrials.gov

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