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Alzheimer DiseasePhase 2NCT05063851

The Use of Memantine for Prevention of Alzheimer's Disease

A Phase 2 study testing Memantine Hydrochloride Tablets in people with Alzheimer Disease, run by University of Virginia at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
Memantine Hydrochloride Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
11 Oct 2021to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Virginia

    Charlottesville, Virginia, 22908

Other trials in United States

About this study

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.

Read the detailed description

The use of memantine for prevention of Alzheimer's Disease (AD) is designed to assess the feasibility of the use of memantine hydrochloride for prevention of AD and provide design elements for a Phase 3 efficacy study.

Up to 128 subjects will be enrolled/screened to achieve a sample size of 32 randomized participants with a 1:1 randomization allocation. The study population will include individuals, 50-65 years of age, who are APOE4 positive with a family history of Alzheimer's Disease who meet all other eligibility criteria.

The schedule of assessments includes screening/baseline, treatment period (including titration up/down) and follow up/end of study over 101 weeks for each subject. Study efficacy assessments are the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Montreal Cognitive Assessment (MoCA), Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL), Cognitive Function Index, Alzheimer's Disease Cooperative Study - Activities of Daily Living Prevention Instrument Activities of Daily Living - Prevention Instrument and the Clinical Dementia Rating Scale (CDR) Scale. Safety assessments include the Center for Epidemiologic Studies Depression Scale (CES-D) Vital Signs, Physical/Neurological Exam, Electrocardiogram, Blood Chemistries, Urinalysis, Medical History, Assessment of Adverse Events and Concomitant Medications, MRI and PET imaging.

Being tested
Memantine Hydrochloride Tablets, Placebo
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Memantine Hydrochloride TabletsDrug

    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.

  • PlaceboDrug

    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.

Study groups in NCT05063851
Study groupRoleWhat they receive
Memantine hydrochlorideExperimentalNot described
Receives: Drug: Memantine Hydrochloride Tablets
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to 24 months

Secondary outcomes (3)

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

    Permutation tests, Fisher's exact tests, or Mann-Whitney U-tests will be used depending on the data distributions observed. This is a needed design estimate for a Phase 3 efficacy trial.

    Measured: Baseline to 24 months

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

    The changes from baseline to 24 months will be calculated for each individual who completes the study. Both absolute and relative changes will be computed for each measurement. T-tests or Mann-Whitney U-test will be used to compare the change scores between arms. Additionally, since measurements are also planned at 12 months, an analysis will be performed using all available data on each subject. This analysis will use a random effects model to estimate the trajectories of change over time in each arm. The random effects model will also be used to assess the potential effect of each demographic variable on the change in RBANS. This is a needed design estimate for a Phase 3 efficacy trial.

    Measured: Baseline to 24 months

  3. Intraclass correlation coefficient (ICC) for longitudinal follow-up

    The ICC will be calculated by dividing the random effects variance in the random effects model (above) by the total variance. This is a needed design estimate for a Phase 3 efficacy trial.

    Measured: Baseline to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2021
  2. Study start11 Oct 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05063851
Sponsor's protocol ID
HSR200202
Status last verified
Jan 2026
First submitted
23 Jul 2021
Last updated
14 Jan 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arp AM, Bloom GS, D'Abreu A, Fansler A, Meegan K, Ratcliffe S, Kapur J, Manning C. The use of memantine for prevention of Alzheimer's disease: Pilot feasibility study rationale and protocol. Contemp Clin Trials Commun. 2026 May 4;51:101644. doi: 10.1016/j.conctc.2026.101644. eCollection 2026 Jun.

    PubMed 42179865

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Memantine Hydrochloride Tablets in people with Alzheimer Disease, run by University of Virginia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Baseline to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05063851, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.

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