The Use of Memantine for Prevention of Alzheimer's Disease

NCT05063851 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: HSR200202
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

As the US population ages, the prevalence of dementia is increasing, and Alzheimer's Disease (AD) is the most prevalent one. Solving the Alzheimer's Disease (AD) epidemic is likely to require preventive therapy beginning many years before symptoms are expected to be evident in at-risk individuals. AD is caused by the dysfunction, loss of synapses, and eventual neuronal death, which may occur up to 25 years before clinical symptoms appear. This study, based off of pre-clinical data, seeks to assess whether it is feasible to use memantine hydrochloride for the prevention of Alzheimer's Disease.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• To assess the feasibility of the use of memantine hydrochloride for prevention of Alzheimer's Disease as measured by the percentage of patients who are lost to follow-up

  The percentage of subjects who are lost to follow-up before completion of the protocol will be calculated, along with 95% confidence intervals. Calculations will be carried out in the entire randomized population, and by treatment arm. Loss to follow-up percentages will be compared between arms using Fisher's exact tests. Permutation tests will be used to assess if any baseline subject characteristics are associated with overall loss to follow-up percentages, or time to loss to follow-up.

  Baseline to 24 months

Secondary Outcomes (3)

• Summary of demographic characteristics of subjects overall, and in each arm.

  Baseline to 24 months

• Mean change in RBANS scores from baseline to end of protocol, overall and in each arm.

  Baseline to 24 months

• Intraclass correlation coefficient (ICC) for longitudinal follow-up

  Baseline to 24 months

Study Arms (2)

Memantine hydrochloride

EXPERIMENTAL

Drug: Memantine Hydrochloride Tablets

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

The recommended starting dose of memantine hydrochloride/placebo is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day.

Placebo

Memantine Hydrochloride Tablets DRUG

The recommended starting dose of memantine hydrochloride/placebo is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day.

Memantine hydrochloride

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 may not qualify 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.

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Memantine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Carol Manning, PhD

  Professor of Neurology

  PRINCIPAL INVESTIGATOR

• Anelyssa D'Abreu, MD

  Associate Professor of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: July 23, 2021
• First Posted: October 1, 2021
• Study Start: October 11, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)