NCT05063851 · Phase 2 · ACTIVE NOT RECRUITING
The Use of Memantine for Prevention of Alzheimer's Disease
This trial is testing whether memantine, an existing drug already used for moderate-to-severe Alzheimer's symptoms, can be given years before symptoms to help protect memory and thinking. Participants take either memantine or a placebo. It is a Phase 2 trial, meaning researchers are testing feasibility and safety, not yet proven or approved for this use.
You may qualify if
- Be between the age of 50 and 65 years at time of informed consent.
- Have a positive family history for dementia (minimum of 1 first degree relative).
- Previously known or documented heterozygote or homozygote ApoE ε4 allele.
- Be able to read and write and must have adequate hearing and visual acuity to complete the psychometric tests.
- Be otherwise healthy for their age group or medically stable with or without medication on the basis of physical examination, medical history, vital signs, and 12-lead ECG performed at screening or at baseline.
- Have Montreal Cognitive Assessment (MOCA) score of 27 or above.
- Have a creatinine clearance (CrCl), estimated using the Cockcroft-Gault formula, greater or equal to 30 mL/minute.
You're excluded if
- A current clinical condition or requires a medication that raises the pH of their urine.
- Severe renal or hepatic impairment.
- Any other abnormality that could cause a possible cognitive deficit (including, but not limited to, vascular encephalopathy or large strokes).
- Contraindications for MRI (e.g., prostheses, implants, claustrophobia, pacemaker) or PET imaging.
- Neurodegenerative disorder known to cause neurocognitive decline
- Relevant history of or current neurological disease other than preclinical AD, which may make interpretation of possible new neurological signs or symptoms difficult.
- Clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease
- Ongoing cancer treatment
- Clinically significant and active psychiatric disorder
- Use of an investigational medical device within 3 months before the planned start of study.
- Current participation in an interventional study with an investigational drug component.
- Major surgery (e.g., requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has major surgery planned during the time the subject is expected to participate in the study.
- Requires treatment with an AChE inhibitor or any of the following: acetazolamide, methazolamide, amantadine, ketamine, dextromethorphan.
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 2026-01-14