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
Overview
- Phase
- Phase 2
- Intervention
- PF-05212377 (SAM-760)
- Conditions
- Alzheimer's Disease
- Sponsor
- Pfizer
- Enrollment
- 186
- Locations
- 60
- Primary Endpoint
- Change From Baseline in ADAS-cog13 Total Score at Week 16
- Status
- Terminated
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
30 mg QD of PF-05212377
Intervention: PF-05212377 (SAM-760)
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in ADAS-cog13 Total Score at Week 16
Time Frame: 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 Outcomes
- Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5)(Baseline and Week 16)