Alzheimer's Disease Education and Referral Center

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

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

Overall Status: 
Terminated
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
60 Years
N/A
Both
No
Inclusion Criteria: 
    • 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
Exclusion Criteria: 
    • 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
Detailed Description: 

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.

Central Contact Information: 

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

Locations: 
Map Marker CityStateZip CodePrimary Contact

Geolocation is 33.6834142, -117.9073244

ATP Clinical Research, Inc
Costa Mesa
California
92626

Geolocation is 32.8475528, -115.5694391

Sun Valley Research Center
Imperial
California
92251

Geolocation is 33.739744, -116.41279

Desert Valley Research
Rancho Mirage
California
92270

Geolocation is 33.7455731, -117.8678338

RAA - Apex Acquisition
Santa Ana
California
92705

Geolocation is 41.4305881, -72.9106202

Geriatric and Adult Psychiatry LLC
Hamden
Connecticut
06518

Geolocation is 41.3052226, -72.9268626

Yale University
New Haven
Connecticut
06510

Geolocation is 41.3052226, -72.9268626

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

Geolocation is 41.3065186, -72.9310714

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

Geolocation is 26.5145591, -80.1540226

Diagnostic Centers of America
Boynton Beach
Florida
33437

Geolocation is 28.5552719, -82.3878709

Meridien Research
Brooksville
Florida
34601

Geolocation is 26.2778269, -80.109357

Quantum Laboratories
Deerfield Beach
Florida
33064

Geolocation is 26.4647478, -80.109357

Brain Matters Research Inc
Delray Beach
Florida
33445

Geolocation is 25.9812024, -80.148379

MD Clinical
Hallandale Beach
Florida
33009

Geolocation is 28.810823, -81.8778582

Compass Research LLC-North Clinic
Leesburg
Florida
34748

Geolocation is 28.9488761, -81.2986741

Medical Research Group of Central Florida
Orange City
Florida
32763

Geolocation is 26.7619563, -80.1037721

Premiere Research Institute
West Palm Beach
Florida
33407

Geolocation is 34.0952227, -84.2173403

Institute for Advanced Medical Research
Alpharetta
Georgia
30005

Geolocation is 33.698565, -84.5431867

Atlanta Center for Medical Research
Atlanta
Georgia
30331

Geolocation is 32.5621719, -84.9921549

Columbus Research & Wellness Institute, Inc.
Columbus
Georgia
31904

Geolocation is 39.7884076, -86.2869507

Covance Central Laboratory Services, Inc.
Indianapolis
Indiana
46214

Geolocation is 39.7884076, -86.2869507

Covance Central Laboratory Services, Inc
Indianapolis
Indiana
46214

Geolocation is 30.2310081, -93.2190898

Lake Charles Clinical Trials
Lake Charles
Louisiana
70629

Geolocation is 42.724305, -84.4796047

Michigan State University Department of Radiology (MRI) or (CT)
East Lansing
Michigan
48824

Geolocation is 42.724305, -84.4796047

Michigan State University
East Lansing
Michigan
48824

Geolocation is 42.724305, -84.4796047

Sparrow Regional Laboratories
Lansing
Michigan
48824

Geolocation is 38.6608855, -90.422618

Metro Imaging (Imaging only)
Creve Coeur
Missouri
63141

Geolocation is 38.6608855, -90.422618

Millennium Psychiatric Associates, LLC
Creve Coeur
Missouri
63141

Geolocation is 40.7700703, -73.9580246

Eastside Comprehensive Medical Center, LLC
New York
New York
10021

Geolocation is 43.1301942, -77.6020569

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

Geolocation is 43.1224766, -77.6242574

Imaging Sciences - MRI University of Rochester Medical Center
Rochester
New York
14642

Geolocation is 40.5944059, -74.0711359

Behavioral Medical Research of Staten Island
Staten Island
New York
10305

Geolocation is 39.9826396, -83.0415078

The Ohio State University - 2006
Columbus
Ohio
43212

Geolocation is 40.1373404, -75.3761952

Keystone Clinical Studies, LLC
Norristown
Pennsylvania
19403

Geolocation is 39.9531865, -75.1749671

eResearch Technology, Inc.
Philadelphia
Pennsylvania
19103

Geolocation is 39.9531865, -75.1749671

eResearch Technology, Incorporated
Philadelphia
Pennsylvania
19103

Geolocation is 32.7791432, -79.9248669

Roper Hospital (Imaging Only)
Charleston
South Carolina
29401

Geolocation is 32.7791432, -79.9248669

Roper St. Francis Healthcare
Charleston
South Carolina
29401

Geolocation is 32.7791432, -79.9248669

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

Geolocation is 35.1376546, -89.7661527

Neurology Clinic, P.C.
Cordova
Tennessee
38018

Geolocation is 30.2961708, -97.7389543

Central Park Imaging Center
Austin
Texas
78705

Geolocation is 30.3558863, -97.6493858

Clinical Pathology Laboratories, Inc
Austin
Texas
78754

Geolocation is 30.3568213, -97.730807

Senior Adults Speciality Research Inc.
Austin
Texas
78757

Geolocation is 33.8954726, -98.544636

Grayline Clinical Drug Trials
Wichita Falls
Texas
76309

Geolocation is 42.8781345, -73.1967741

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

Geolocation is 43.0972174, -89.5042876

Dean Foundation for Health, Research and Education
Middleton
Wisconsin
53562

Geolocation is 43.0513426, -88.0411993

San Camillo
Milwaukee
Wisconsin
53226

Geolocation is 39.9531865, -75.1749671

eResearch Technology, Incorporated
Philadlephia
Wisconsin
19103

Geolocation is 43.0116784, -88.2314813

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

Geolocation is 43.0116784, -88.2314813

Merrill Hills Manor
Waukesha
Wisconsin
53188

Geolocation is 44.6582865, -63.6700901

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

Geolocation is 42.403854, -82.1851287

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

Geolocation is 45.4827785, -75.6872156

Recherches Neuro-Hippocampe Inc.
Gatineau
Quebec
J8T 8J1
Lead Sponsor: 
Agency
Pfizer
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Pfizer CT.gov Call Center
Study Director
Pfizer
Study Contact: 
NamePhoneEmail
Pfizer CT.gov Call Center
1-800-718-1021
Locations
 
 
ClinicalTrials.gov ID 
NCT01712074 (follow link to view full record on ct.gov in new window)
Official Title: 
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
Study Start Date: 
November 2012
Study End Date: 
May 2016
Disease Stage: 
Early
Middle
Enrollment: 
342