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

Phase 2

Terminated

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
30 mg QD of PF-05212377	PF-05212377 (SAM-760)	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in ADAS-cog13 Total Score at Week 16	Baseline and 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)	Baseline and Week 16	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.

Locations (60): 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
Yale University
🇺🇸
New Haven, Connecticut, United States
Yale-New Haven Hospital, Temple Radiology
🇺🇸
New Haven, Connecticut, United States
Yale University School of Medicine, MRI Research Center (MRI)
🇺🇸
New Haven, Connecticut, United States
Diagnostic Centers of America
🇺🇸
Boynton Beach, Florida, United States
Meridien Research
🇺🇸
Brooksville, Florida, United States
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ATP Clinical Research, Inc
🇺🇸Costa Mesa, California, United States