Skip to main content
Delfa

← Trials/Trial dossier/NCT05063851

Active not recruitingPhase 2

The Use of Memantine for Prevention of Alzheimer's Disease

Asset

Memantine

Listed sites

1

Recruiting sites

-

Enrollment

32

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•MoCA 27•MRI contraindications excluded

Primary endpoint

•Feasibility of the use of memantine hydrochloride for prevention of Alzheimer's

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDHSR200202
NCT IDNCT05063851

Timeline

Milestones

Study first posted2021-10-01actual
Study start2021-10-11actual
Last update posted2026-01-14actual
Primary completion2026-12estimated (month precision)
Study completion2026-12estimated (month precision)

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
2
Global cognition
1
Other clinical outcomes
1

Global cognition

1 endpoint
Secondary/protocol endpoint

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

Time frame:Baseline to 24 months

percent change from baseline, improvement

Other clinical outcomes

1 endpoint
Primary/protocol endpoint

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

time to event, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

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

Time frame:Baseline to 24 months

descriptive

Secondary/protocol endpoint/low confidence

Intraclass correlation coefficient (ICC) for longitudinal follow-up

Time frame:Baseline to 24 months

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.