CONNECTION

CompletedPhase 3

A Safety and Efficacy Study of Oral Dimebon in Patients With Mild-To-Moderate Alzheimer's Disease

A Global Phase 3, Double-Blind, Placebo-Controlled Safety and Efficacy Study of Oral Dimebon in Patients With Mild-to-Moderate Alzheimer's Disease (CONNECTION)

Lead sponsor

Medivation, Inc.

Asset

Dimebon

Listed sites

Recruiting sites

Enrollment

598

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 10-24•Study partner/caregiver required

Primary endpoints

•ADAS-Cog•Effect of Dimebon

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 IDCONNECTION

SecondaryDIM14

NCT IDNCT00675623

Timeline

Milestones

Study start2008-05 (month precision)

Study first posted2008-05-09estimated

Primary completion2009-12actual (month precision)

Last update posted2016-09-27estimated

Assets

Drug assets

Dimebon

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Mild-to-Moderate Alzheimer's disease

•Probable AD (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV)

•MMSE score 10-24 inclusive

•Computerized tomography (CT) san or magnetic resonance imaging (MRI) consistent with AD

•Caregiver who cares for the patient at least 5 days per week

Exclusion criteria

•Anti-dementia drugs including cholinesterase-inhibitors or N-methyl-D-aspartate receptor (NMDA) receptor antagonists within 90 days

•Other causes of dementia

•Other primary psychiatric or neurological disorders

•Unstable medical illnesses or significant hepatic or renal disease

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

Global cognition

Function / daily living

Behavior / neuropsychiatric

Caregiver / quality of life

Global cognition

1 endpoint

Primary/protocol endpoint

To determine the effect of Dimebon as compared to placebo on the primary measure of cognition and memory, the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog).

Time frame:Week 26

ADAS-Cog

descriptive

Function / daily living

1 endpoint

Secondary/protocol endpoint

To determine the effect of Dimebon as compared to placebo on a measure of self care and daily function, the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL).

Time frame:Week 26

ADCS-Activities of Daily Living (ADCS-ADL)

descriptive

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

To determine the effect of Dimebon as compared to placebo on a measure of behavior, the Neuropsychiatric Inventory (NPI).

Time frame:Week 26

Neuropsychiatric Inventory (NPI)

descriptive

Caregiver / quality of life

1 endpoint

Primary/protocol endpoint

To determine the effect of Dimebon as compared to placebo on the primary measure of global function, the Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus).

Time frame:Week 26

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.