NCT03703856 · Phase 4 · ACTIVE NOT RECRUITING

Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease

This trial is testing memantine, an FDA-approved Alzheimer's medication, to understand which patients respond to it best by tracking brain function and symptom changes over time. Researchers want to find biomarkers that predict who benefits most from the drug. It is a Phase 4 trial, meaning memantine is already approved and this study is gathering deeper evidence about how and for whom it works.

Eligibility criteria

Inclusion:
1. Alzheimer's Disease Research Center-confirmed diagnosis of AD
2. Mini-Mental State Examination (MMSE) score 10-22 OR a Montreal Cognitive Assessment (MOCA) score of 15-24
3. Age 50-83 y
4. Knowledgeable caregiver
5. Ambulatory
6. Medically stable;
7. Audiometric testing (detection \< or = to 45 db(A) at 1000 Hz)
8. Informed consent
Exclusion:
1. Active systemic illness (e.g. heart disease, liver failure, renal insufficiency, cancer, HIV, tuberculosis, Hepatitis C)
2. Current psychiatric or neurologic illness other than AD
3. History of vascular disease, myocardial infarction, cerebrovascular accidents, transient ischemic attack, seizure, head injury with loss of consciousness; substance dependence (including alcohol and Opioid)
4. Past treatment with memantine; unable to tolerate acetylcholinesterase inhibitor
5. Investigational drug treatment \< 30 d of screening
6. Current meds: amantadine, riluzole, other pro-cognitive medication, opioids
7. Positive urine toxicology for non-prescribed psychoactive substance
8. Actively enrolled in cognitive remediation therapy

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-01-07

View full record on ClinicalTrials.gov

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