WithdrawnPhase 2

A Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

A Phase 2, Multi-Center, Double-Blinded, Placebo-Controlled Safety And Efficacy Study Of Oral PF-01913539 In Patients With Mild To Moderate Alzheimer's Disease

Lead sponsor

Pfizer

Asset

Dimebon

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 10-24

Primary endpoints

•ADAS-Cog•Distribution of Clinician's Interview-Based Impression of Change plus Caregiver

Identifiers

Registered as

Org study IDB1451010

NCT IDNCT01066481

Timeline

Milestones

Study first posted2010-02-10estimated

Study start2010-04 (month precision)

Last update posted2010-06-29estimated

Primary completion2012-03estimated (month precision)

Study completion2012-04estimated (month precision)

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

•MMSE score 10-24 inclusive

Exclusion criteria

•Administration of anti-dementia drugs including cholinesterase-inhibitors or NMDA receptor antagonists within 90 days

•Complication of other causes of dementia

Endpoints (8)

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

Caregiver / quality of life

Function / daily living

Behavior / neuropsychiatric

Safety / tolerability / PK

Other (unclassified)

Global cognition

2 endpoints

Primary/protocol endpoint

Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.

Time frame:26 weeks

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

Mean change in Mini-Mental State Examination (MMSE) score from baseline.

Time frame:6, 12, 18, 26 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.

Time frame:12, 26 weeks

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Mean change in Neuropsychiatric Inventory (NPI) score from baseline.

Time frame:12, 26 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Caregiver / quality of life

2 endpoints

Primary/protocol endpoint

Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input

Time frame:26 weeks

descriptive

Secondary/protocol endpoint

Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.

Time frame:12, 26 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis).

Time frame:12, 26 weeks

event count, event

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Population PK parameters (CL/F, V/F, etc.)

Time frame:26 weeks

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.