CompletedPhase 4

Study of Memantine in Assessment of Selected Measures of Volumetric Magnetic Resonance Imaging (MRI) and Cognition in Moderate AD (Alzheimer's Disease)

An Open-Label Exploratory Study With Memantine: Assessment of Selected Measures of Volumetric MRI and Cognition in Patients With Moderate Dementia of the Alzheimer's Type

Lead sponsor

Forest Laboratories

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 15-20•AD symptomatic therapy: stable

Primary endpoints

•Efficacy•Total brain atrophy on MRI

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-15

NCT IDNCT00334906

Timeline

Milestones

Study start2005-07 (month precision)

Study first posted2006-06-08estimated

Primary completion2007-11actual (month precision)

Last update posted2008-01-07estimated

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

•Ambulatory male or female patients at least 50 years of age (females at least 2 years postmenopausal)

•A diagnosis of probable AD [according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Associations (NINCDS-ADRDA) criteria] of moderate severity [Mini-Mental State Examination score between 15 and 20, inclusive]

•On a stable dose of Food and Drug Administration (FDA)-approved acetylcholinesterase inhibitor

Exclusion criteria

•Current Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV) Axis I disorder other than AD

•Previous imaging results not consistent with the diagnosis of AD

•Modified Hachinski Ischemia Score greater than 4

•Evidence of other neurologic disorders

•Inability to participate in MRI testing

•No clinically significant systemic disease

•A known or suspected history of alcohol or drug abuse in the past 10 years

•Taking excluded medication

•Previous treatment with commercial memantine

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

Memory

Neuroimaging

Safety / tolerability / PK

Other (unclassified)

Memory

1 endpoint

Secondary/protocol endpoint

Other measures of brain atrophy on MRI, change from baseline in selected cognitive measures assessing multiple cognitive domains including memory, attention, motor-speed, auditory comprehension, and verbal fluency

change from baseline, improvement

Neuroimaging

1 endpoint

Primary/protocol endpoint

Total brain atrophy on MRI

descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Efficacy

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.