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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
186
30 mg QD of PF-05212377 (SAM-760)
Placebo QD
ATP Clinical Research, Inc
Costa Mesa, California, United States
Sun Valley Research Center
Imperial, California, United States
Desert Valley Research
Rancho Mirage, California, United States
RAA - Apex Aquisition, LLC
Santa Ana, California, United States
Geriatric and Adult Psychiatry LLC
Hamden, Connecticut, United States
Change From Baseline in ADAS-cog13 Total Score at Week 16
ADAS-cog13 (13-item ADAS cog) 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 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.
Time frame: Baseline and Week 16
Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)
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 (for 12 behavioral domains) 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.
Time frame: Baseline and Week 16
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Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital, Temple Radiology
New Haven, Connecticut, United States
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New Haven, Connecticut, United States
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Boynton Beach, Florida, United States
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Brooksville, Florida, United States
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