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

Phase 2

Withdrawn

• Conditions: Alzheimer's Disease; Dementia; Dimebon; Investigational Drug
• Interventions: Drug: PF-01913539 5 mg; Drug: Placebo

• Registration Number: NCT01066481
• Lead Sponsor: Pfizer

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Study Start: 2010-04
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-28
• Last Update Posted: 2010-06-29
• Primary Completion: 2012-03
• Study Completion: 2012-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PF-01913539 5 mg three times daily	PF-01913539 5 mg	PF-01913539 5 mg three times daily for 6 months
PF-01913539 20 mg three times daily	PF-01913539 5 mg	PF-01913539 20 mg three times daily for 6 months
Placebo	Placebo	Placebo three times daily for 6 months

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.	12, 26 weeks
Mean change in Neuropsychiatric Inventory (NPI) score from baseline.	12, 26 weeks
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
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
Population PK parameters (CL/F, V/F, etc.)	26 weeks