Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- Change from Baseline (Week 4) to 12 weeks after the start of double-blind study medication on the ADAS-cog13 total score (Week 16) [ Time Frame: Week 16 ] [ Designated as safety issue: No ]ADAS-cog13 is a psychometric instrument that evaluates word recall, ability to follow commands,constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.
- Change from baseline (Week 4) to 12 weeks after the start of double-blind study medication on the NPI total score (Week 16). [ Time Frame: Week 16 ] [ Designated as safety issue: No ]The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.
|Study Start Date:||November 2012|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||January 2016 (Final data collection date for primary outcome measure)|
|Experimental: 30 mg QD of PF-05212377||
Drug: PF-05212377 (SAM-760)
30 mg QD of PF-05212377 (SAM-760)
|Placebo Comparator: Placebo||
Please refer to this study by its ClinicalTrials.gov identifier: NCT01712074
|Contact: Pfizer CT.gov Call Center||1-800-718-1021|
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|Study Director:||Pfizer CT.gov Call Center||Pfizer|