CompletedPhase 3

An Evaluation of the Safety and Efficacy of Memantine in Agitated Patients With Moderate to Severe Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Non-Institutionalized Agitated Patients With Moderate to Severe Alzheimer's Disease

Lead sponsor

Forest Laboratories

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•AD symptomatic therapy: stable ≥3 months

Primary endpoint

•Neuropsychiatric Inventory (NPI)

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 IDMEM-MD-23

NCT IDNCT00097916

Timeline

Milestones

Study start2004-09 (month precision)

Study first posted2004-12-02estimated

Primary completion2006-04actual (month precision)

Study completion2006-04actual (month precision)

Last update posted2012-03-05estimated

Assets

Drug assets

Memantine

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Moderate to Severe Alzheimer's Disease with a score greater than or equal to 4 on agitation/aggression domain of NPI

•Stable dose of donepezil for 3 months

Exclusion criteria

•Other evidence of psychiatric disorders

•Oncologic diagnosis

•Clinically significant gastrointestinal, renal, hepatic, endocrine or cardiovascular disease

Endpoints (5)

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

Function / daily living

Other clinical outcomes

Function / daily living

1 endpoint

Secondary/protocol endpoint

ADCS-ADL

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

3 endpoints

Primary/protocol endpoint

Neuropsychiatric Inventory

Neuropsychiatric Inventory (NPI)

descriptive

Secondary/protocol endpoint

Cohen Mansfield Agitation Inventory

descriptive

Secondary/protocol endpoint

Agitation/aggression domain of Neuropsychiatric Inventory (NPI)

Neuropsychiatric Inventory (NPI)

descriptive

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Clinical Global Impression Scale

descriptive

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.