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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01066481

Enrollment

Registered

2010-02-10

Start date

2010-04-30

Completion date

2012-04-30

Last updated

2010-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Dementia, Dimebon, Investigational Drug

Keywords

Alzheimer's disease, clinical trial, memory loss, investigational drug, neurodegenerative disease, dementia

Brief summary

The purpose of this study is to demonstrate the safety and efficacy of PF-01913539 in the treatment of patients with mild-to-moderate Alzheimer's Disease. It is a 6-month study enrolling 651 patients in Japan, Hong Kong, Korea, and Republic of China. All patients completing the 6-month study will be eligible to receive PF-01913539 in an open-label extension trial (B1451031).

Interventions

DRUGPF-01913539 5 mg

PF-01913539 5 mg three times daily for 6 months

DRUGPlacebo

Placebo three times daily for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.	26 weeks
Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input	26 weeks

Secondary

Measure	Time frame
Mean change in Mini-Mental State Examination (MMSE) score from baseline.	6, 12, 18, 26 weeks
Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.	12, 26 weeks
Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.	12, 26 weeks
Population PK parameters (CL/F, V/F, etc.)	26 weeks
Adverse events, physical examination, vital signs (blood pressure, temperature, and heart rate), 12-lead ECG, and laboratory tests (hematology, blood chemistry and urinalysis).	12, 26 weeks
Mean change in Neuropsychiatric Inventory (NPI) score from baseline.	12, 26 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026