Conditions: Alzheimer's Disease
Keywords: Randomized Double Blind Safety and Efficacy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 186
Healthy volunteers: no

Brief summary:
This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: PF-05212377 (SAM-760) intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mg QD of PF-05212377 (SAM-760) intervention 2: Placebo QD

Protocol document: