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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01712074

Run by

Pfizer

People needed

186

Starts

2012-11-01

Expected to finish

2015-09-01

Last updated by the study team

2017-03-20

Who can join

Age: 60 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• 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
• Quantum Laboratories — Deerfield Beach, Florida, United States
• Brain Matters Research Inc — Delray Beach, Florida, United States
• MD Clinical — Hallandale, Florida, United States
• Compass Research LLC-North Clinic — Leesburg, Florida, United States
• Medical Research Group of Central Florida — Orange City, Florida, United States
• Premiere Research Institute — West Palm Beach, Florida, United States
• Institute for Advanced Medical Research — Alpharetta, Georgia, United States
• Atlanta Center for Medical Research — Atlanta, Georgia, United States
• Columbus Research & Wellness Institute, Inc. — Columbus, Georgia, United States
• Lake Charles Clinical Trials — Lake Charles, Louisiana, United States
• Michigan State University — East Lansing, Michigan, United States
• Metro Imaging (Imaging only) — Creve Coeur, Missouri, United States
• Millennium Psychiatric Associates, LLC — Creve Coeur, Missouri, United States
• Eastside Comprehensive Medical Center, LLC — New York, New York, United States
• University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center — Rochester, New York, United States
• ATP Clinical Research, Inc — Costa Mesa, California, United States

Full record on ClinicalTrials.gov

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