Using memantine to prevent Alzheimer's disease

The Use of Memantine for Prevention of Alzheimer's Disease

This study is testing if the drug memantine can help prevent Alzheimer's disease in people aged 50-65 who are at higher risk due to their genetics and family history.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 50 Years to 65 Years
• Sex: All
• Sponsor: University of Virginia (other)
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT05063851 on ClinicalTrials.gov

What this trial studies

This study evaluates the feasibility of using memantine hydrochloride as a preventive treatment for Alzheimer's Disease (AD) in individuals at risk. It targets participants aged 50-65 who are APOE4 positive and have a family history of AD. The study will enroll up to 128 subjects, with 32 randomized to receive either memantine or a placebo over a treatment period of 101 weeks. Various cognitive and safety assessments will be conducted to determine the effectiveness and safety of the intervention.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50-65 who are APOE4 positive and have a family history of Alzheimer's Disease.

Not a fit: Patients without a family history of dementia or those who do not carry the APOE4 allele may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly delay or prevent the onset of Alzheimer's Disease in at-risk individuals.

How similar studies have performed: While there have been studies exploring various preventive strategies for Alzheimer's, the specific use of memantine for this purpose is relatively novel and untested.

Eligibility criteria

Inclusion Criteria:

1. Be between the age of 50 and 65 years at time of informed consent.
2. Have a positive family history for dementia (minimum of 1 first degree relative).
3. Previously known or documented heterozygote or homozygote ApoE ε4 allele.
4. Be able to read and write and must have adequate hearing and visual acuity to complete the psychometric tests.
5. 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.
6. Have Montreal Cognitive Assessment (MOCA) score of 27 or above.
7. Have a creatinine clearance (CrCl), estimated using the Cockcroft-Gault formula, greater or equal to 30 mL/minute.

Exclusion Criteria:

1. A current clinical condition or requires a medication that raises the pH of their urine.
2. Severe renal or hepatic impairment.
3. Any other abnormality that could cause a possible cognitive deficit (including, but not limited to, vascular encephalopathy or large strokes).
4. Contraindications for MRI (e.g., prostheses, implants, claustrophobia, pacemaker) or PET imaging.
5. Neurodegenerative disorder known to cause neurocognitive decline
6. Relevant history of or current neurological disease other than preclinical AD, which may make interpretation of possible new neurological signs or symptoms difficult.
7. Clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease
8. Ongoing cancer treatment
9. Clinically significant and active psychiatric disorder
10. Use of an investigational medical device within 3 months before the planned start of study.
11. Current participation in an interventional study with an investigational drug component.
12. 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.
13. Requires treatment with an AChE inhibitor or any of the following: acetazolamide, methazolamide, amantadine, ketamine, dextromethorphan.

Where this trial is running

Charlottesville, Virginia

• University of Virginia — Charlottesville, Virginia, United States (RECRUITING)

Study contacts

• Principal investigator: Carol Manning, PhD — Professor of Neurology
• Study coordinator: Amy Fansler

Conditions: Alzheimer Disease