TerminatedPhase 3Results posted

An Extension To The B1451006 Protocol To Evaluate The Safety and Efficacy of Dimebon In Subjects With Moderate-to-Severe Alzheimer's Disease

An Open-Label Extension To The B1451006 Protocol To Evaluate The Safety And Efficacy Of Dimebon (Latrepirdine, PF-01913539) In Subjects With Moderate-To-Severe Alzheimer's Disease

Lead sponsor

Pfizer

Asset

Dimebon

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•Age ≥50

Primary endpoint

•Adverse Events (AEs)

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 IDB1451030

NCT IDNCT01066546

Timeline

Milestones

Study first posted2010-02-10estimated

Study start2010-04 (month precision)

Primary completion2010-07actual (month precision)

Study completion2010-07actual (month precision)

Last update posted2012-10-02estimated

Results first posted2012-10-02estimated

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

•Successful completion of 6 months treatment in the previous B1451006 Phase 3 dimebon study

Exclusion criteria

•Any major medical illness or unstable medical condition that may increase the risk associated with study participation or investigational product administration or may interfere with the ability to interpret study safety data

Endpoints (16)

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

Global cognition

Function / daily living

Caregiver / quality of life

Safety / tolerability / PK

Global cognition

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26

Time frame:Baseline, Week 6, 12, 26

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26

Time frame:Baseline, Week 12, 26

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Severe Impairment Battery (SIB) at Week 6, 12 and 26

Time frame:Baseline, Week 6, 12, 26

change from baseline, improvement

Secondary/registry result

Change From Baseline in Mini-Mental State Examination (MMSE) at Week 12 and 26

Time frame:Baseline, Week 12, 26

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26

Time frame:Baseline, Week 6, 12, 26

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living-Severe Version (ADCS-ADLsev) at Week 6, 12 and 26

Time frame:Baseline, Week 6, 12, 26

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

6 endpoints

Secondary/protocol endpoint

Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26

Time frame:Baseline, Week 6, 12, 26

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/protocol endpoint

Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26

Time frame:Week 26

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/protocol endpoint

Change From Baseline in European Quality of Life 5 Domain Scale (EQ-5D) at Week 12 and 16

Time frame:Baseline, Week 12, 26

change from baseline, improvement

Secondary/registry result

Change From Baseline in Neuropsychiatric Inventory (NPI) at Week 6, 12 and 26

Time frame:Baseline, Week 6, 12, 26

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Sum of Delusions and Hallucinations Sub-domain Scores of Neuropsychiatric Inventory (NPI) at Week 26

Time frame:Week 26

Neuropsychiatric Inventory (NPI)

event count, event

Secondary/registry result

Change From Baseline in European Quality of Life 5 Domain Scale (EQ-5D) at Week 12 and 16

Time frame:Baseline, Week 12, 26

change from baseline, improvement

Caregiver / quality of life

2 endpoints

Secondary/protocol endpoint

Change From Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) at Week 12 and 26

Time frame:Baseline, Week 12, 26

change from baseline, improvement

Secondary/registry result

Change From Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) at Week 12 and 26

Time frame:Baseline, Week 12, 26

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Number of Participants With Adverse Events (AEs)

Time frame:Baseline up to 4 weeks after last dose of study treatment

event count, event

Primary/registry result

Number of Participants With Adverse Events (AEs)

Time frame:Baseline up to 4 weeks after last dose of study treatment

event count, event

Posted result

Group	Value (number), participants	Reported bounds
Dimebonn=5 Participants	2	-

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.