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PF-05212377 for People with Alzheimer's Disease and Neuropsychiatric Symptoms

Terminated

This study will evaluate the safety and efficacy of the experimental drug PF-05212377 as a possible treatment for people with mild to moderate Alzheimer's disease and neuropsychiatric symptoms.

Minimum Age Maximum Age Gender Healthy Volunteers
60 Years N/A Both No
November 2012
May 2016
342

  • Clinical diagnosis of probable Alzheimer's disease, with supportive brain imaging results
  • Existing neuropsychiatric symptoms, as defined by a score equal or greater than 10 on the Neuropsychiatric Inventory at screening, arising from item scores equal or greater than 2 on at least two domains
  • Taking donepezil (stable dose of 5 or 10 mg) for at least 4 months, with no intent to change for the duration of the study

  • Extreme agitation, physical aggression, or violence to self, caregiver, or others and/or an inability to complete the ADAS-Cog assessment at screening
  • Major structural brain disease other than Alzheimer's
  • Other severe medical or psychiatric condition or abnormal lab result

This 18-week study will evaluate the safety and efficacy of the experimental drug PF-05212377 as a possible treatment for people with mild to moderate Alzheimer's disease and neuropsychiatric symptoms, such as agitation and aggression. All participants take the Alzheimer's drug donepezil. Researchers will evaluate the effect of the drug, a small-molecule compound, on participants' cognition and and neuropsychatric symptoms.

For more information about this study or study sites, contact the Pfizer CT.gov Call Center at 1-800-718-1021.

Name City State Zip Status Primary Contact
ATP Clinical Research, Inc
Costa Mesa California 92626

Sun Valley Research Center
Imperial California 92251

Desert Valley Research
Rancho Mirage California 92270

RAA - Apex Aquisition, LLC
Santa Ana California 92705

Geriatric and Adult Psychiatry LLC
Hamden Connecticut 06518

Yale University
New Haven Connecticut 06510

Yale-New Haven Hospital, Temple Radiology
New Haven Connecticut 06510

Yale University School of Medicine, MRI Research Center (MRI)
New Haven Connecticut 06520

Diagnostic Centers of America
Boynton Beach Florida 33437

Meridien Research
Brooksville Florida 34601

Quantum Laboratories
Deerfield Beach Florida 33064

Brain Matters Research Inc
Delray Beach Florida 33445

MD Clinical
Hallandale Beach Florida 33009

Compass Research LLC-North Clinic
Leesburg Florida 34748

Medical Research Group of Central Florida
Orange City Florida 32763

Premiere Research Institute
West Palm Beach Florida 33407

Institute for Advanced Medical Research
Alpharetta Georgia 30005

Atlanta Center for Medical Research
Atlanta Georgia 30331

Columbus Research & Wellness Institute, Inc.
Columbus Georgia 31904

Lake Charles Clinical Trials
Lake Charles Louisiana 70629

Michigan State University
East Lansing Michigan 48824

Metro Imaging (Imaging only)
Creve Coeur Missouri 63141

Millennium Psychiatric Associates, LLC
Creve Coeur Missouri 63141

Eastside Comprehensive Medical Center, LLC
New York New York 10021

University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center
Rochester New York 14620

University of Rochester Medical Center (MRI Imaging Only)
Rochester New York 14642

Behavioral Medical Research of Staten Island
Staten Island New York 10305

The Ohio State University (administrative offices only)
Columbus Ohio 43212

The Ohio State University - 2050
Columbus Ohio 43221

Keystone Clinical Studies, LLC
Norristown Pennsylvania 19403

Roper Hospital (Imaging Only)
Charleston South Carolina 29401

Roper St. Francis Healthcare
Charleston South Carolina 29401

Roper St. Francis Pharmacy (IP Shipment/Storage)
Charleston South Carolina 29401

Neurology Clinic, P.C.
Cordova Tennessee 38018

Senior Adults Speciality Research Inc.
Austin Texas 78757

Grayline Clinical Drug Trials
Wichita Falls Texas 76309

Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic
Bennington Vermont 05201

Dean Foundation for Health, Research and Education
Middleton Wisconsin 53562

Cary J. Kohlenberg, MD, dba, IPC Research
Waukesha Wisconsin 53188

Merrill Hills Manor
Waukesha Wisconsin 53226

True North Clinical Research Halifax, Inc.
Halifax Nova Scotia B3S 1M7

Chatham-kent Clinical Trials Research Centre
Chatham Ontario N7L 1C1

Chatham-Kent Clinical Trials Research Centre
Chatham Ontario N7M 5L9

Recherches Neuro-Hippocampe Inc.
Gatineau Quebec J8T 8J1

Pfizer

Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer

Name Phone Email
Pfizer CT.gov Call Center 1-800-718-1021

NCT01712074

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