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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Alzheimer's Disease
- Sponsor
- Pfizer
- Primary Endpoint
- Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.
- Status
- Withdrawn
- Last Updated
- 15 years ago
Overview
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).
Investigators
Eligibility Criteria
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
Arms & Interventions
Placebo
Placebo three times daily for 6 months
Intervention: Placebo
PF-01913539 5 mg three times daily
PF-01913539 5 mg three times daily for 6 months
Intervention: PF-01913539 5 mg
PF-01913539 20 mg three times daily
PF-01913539 20 mg three times daily for 6 months
Intervention: PF-01913539 5 mg
Outcomes
Primary Outcomes
Mean change in the Alzheimer's Disease Assessment Scale Cognitive Subscale (ADAS-cog) score from baseline.
Time Frame: 26 weeks
Distribution of Clinician's Interview-Based Impression of Change plus Caregiver (CIBIC-plus) Input
Time Frame: 26 weeks
Secondary Outcomes
- 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)