Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil



Status:Terminated
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:60 - Any
Updated:4/21/2016
Start Date:November 2012
End Date:September 2015

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A Randomized, 18-week, Placebo-controlled, Double-blind, Parallel Group Study Of The Safety And Efficacy Of Pf-05212377 (Sam-760) In Subjects With Mild-to-moderate Alzheimer's Disease With Existing Neuropsychiatric Symptoms On A Stable Daily Dose Of Donepezil

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.


Inclusion Criteria:

- Clinical diagnosis of probable AD with supportive brain imaging documentation

- Have existing neuropsychiatric symptoms as defined by a score equal or greater than
10 on the NPI at screening, arising from item scores equal or greater than 2
(frequency X severity) on at least 2 domains.

- Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with
no intent to change such for the duration of the study.

Exclusion Criteria:

- Demonstrate extreme agitation, physical aggression or violence to themselves, their
caregiver, or others, and/or an inability to complete the ADAS-cog assessment at
Screening.

- Have major structural brain disease other than Alzheimer's Disease

- Other severe acute or chronical medical or psychiatric condition or laboratory
abnormality
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Charleston, South Carolina 29401
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