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CompletedPhase 4Results posted

Biomarker Predictors of Memantine Sensitivity in Patients With Alzheimer's Disease

Lead sponsor

University of California, San Diego

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-22•MoCA 15-24

Primary endpoint

•ADAS-Cog

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

NCT IDNCT03703856

Org study IDR01AG059640-01https://reporter.nih.gov/quickSearch/R01AG059640-01

Timeline

Milestones

Study first posted2018-10-12actual

Study start2019-01-31actual

Primary completion2025-01-08actual

Study completion2025-12-30actual

Results first posted2026-01-07actual

Last update posted2026-04-16actual

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age83 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Inclusion:

1. Alzheimer's Disease Research Center-confirmed diagnosis of AD

2. Mini-Mental State Examination (MMSE) score 10-22 OR a Montreal Cognitive Assessment (MOCA) score of 15-24

3. Age 50-83 y

4. Knowledgeable caregiver

5. Ambulatory

6. Medically stable;

7. Audiometric testing (detection < or = to 45 db(A) at 1000 Hz)

8. Informed consent

Exclusion:

1. Active systemic illness (e.g. heart disease, liver failure, renal insufficiency, cancer, HIV, tuberculosis, Hepatitis C)

2. Current psychiatric or neurologic illness other than AD

3. History of vascular disease, myocardial infarction, cerebrovascular accidents, transient ischemic attack, seizure, head injury with loss of consciousness; substance dependence (including alcohol and Opioid)

4. Past treatment with memantine; unable to tolerate acetylcholinesterase inhibitor

5. Investigational drug treatment < 30 d of screening

6. Current meds: amantadine, riluzole, other pro-cognitive medication, opioids

7. Positive urine toxicology for non-prescribed psychoactive substance

8. Actively enrolled in cognitive remediation therapy

Endpoints (6)

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

Behavior / neuropsychiatric

Global cognition

2 endpoints

Primary/protocol endpoint

Change From Baseline Measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 Weeks

Time frame:0, 8, 16, 24 weeks

ADAS-Cog

change from baseline, improvement

Primary/registry result

Change From Baseline Measure in Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog) at 8, 16 and 24 Weeks

Time frame:0, 8, 16, 24 weeks

ADAS-Cog

change from baseline, improvement

Posted result

Group	Value (mean), scores on a scale	Standard deviation
MemantineBaselinen=23 Participants	19.76	8.97
Week 8n=23 Participants	19.81	9.85
Week 16n=23 Participants	19.94	9.55
Week 24n=23 Participants	20.79	11.03

p0.68ANOVA

Change in ADAS-Cog score over time

Behavior / neuropsychiatric

4 endpoints

Secondary/protocol endpoint

Change From Baseline Measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 Weeks

Time frame:0, 8, 16, 24 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change From Baseline Measure in Neuropsychiatric Inventory-Questionnaire (NPI-Q) at 8, 16 and 24 Weeks

Time frame:0, 8, 16, 24 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
MemantineBaselinen=53 Participants	4.27	4.05
Week 8n=53 Participants	3.55	3.36
Week 16n=53 Participants	3.05	2.38
Week 24n=53 Participants	4.09	3.57

p>0.05ANOVA

Other/protocol endpoint

Change From Baseline Measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 Weeks

Time frame:0, 8, 16, 24 weeks

change from baseline, improvement

Other_pre_specified/registry result

Change From Baseline Measure in Geriatric Depression Scale (GDS) at 8, 16 and 24 Weeks

Time frame:0, 8, 16, 24 weeks

change from baseline, improvement

Posted result

Group	Value (mean), score on a scale	Standard deviation
MemantineBaselinen=53 Participants	6.23	5.66
Week 8n=53 Participants	6.05	5.92
Week 16n=53 Participants	6.09	6.69
Week 24n=53 Participants	6.64	6.89

p>0.05ANOVA

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.