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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
PF-01913539 5 mg three times daily for 6 months
PF-01913539 5 mg three times daily for 6 months
Placebo three times daily for 6 months
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
Mean change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADAS-ADL) score from baseline.
Time frame: 12, 26 weeks
Mean change in Neuropsychiatric Inventory (NPI) score from baseline.
Time frame: 12, 26 weeks
Mean change in Mini-Mental State Examination (MMSE) score from baseline.
Time frame: 6, 12, 18, 26 weeks
Mean change in each item of Resource Utilization In Dementia(RUD) Lite from baseline.
Time frame: 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).
Time frame: 12, 26 weeks
Population PK parameters (CL/F, V/F, etc.)
Time frame: 26 weeks
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