CompletedPhase 4Results posted

Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)

Lead sponsor

Forest Laboratories

Asset

Memantine

Listed sites

Recruiting sites

Enrollment

265

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Alzheimer's disease•MMSE 10-19

Primary endpoint

•Functional Linguistic Communication Inventory (FLCI)

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-71

NCT IDNCT00469456

Timeline

Milestones

Study start2007-04 (month precision)

Study first posted2007-05-04estimated

Primary completion2008-11actual (month precision)

Study completion2008-11actual (month precision)

Results first posted2009-12-07estimated

Last update posted2009-12-24estimated

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

•Male and female outpatients, 50 years or older, native English speakers, meeting National Institute of Neurological and Communicative Disorders and Stroke--Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD with a Mini Mental State Examination (MMSE) score of 10 to 19 at Screening and Baseline

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

•Clinically significant systemic disease

•A known or suspected history of alcohol or drug abuse in the past 5 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.

Executive function / language

4 endpoints

Primary/protocol endpoint

Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12

Time frame:Baseline to Week 12

change from baseline, improvement

Primary/registry result

Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12

Time frame:Baseline to Week 12

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebon=124 Participants	-0.6	0.59
Memantinen=133 Participants	0.7	0.57

Mean Difference (Final Values)1.395% CI-0.1 - 2.8p0.070ANCOVA

The primary efficacy parameter was change from Baseline to Week 12 in FLCI total score. Missing FLCI total scores at Week 12 were imputed using the last-observation-carried-forward (LOCF) approach.

Secondary/protocol endpoint

Change From Baseline in American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) [Total Score of Social Communication and Communication of Basic Needs Subscores] at Week 12

Time frame:Baseline to Week 12

change from baseline, improvement

Secondary/registry result

Time frame:Baseline to Week 12

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Units on a scale	Standard error
Placebon=124 Participants	-5.3	2.06
Memantinen=133 Participants	0.5	1.99

Mean Difference (Final Values)5.995% CI0.9 - 10.9p0.022ANCOVA

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.