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: 
Recruiting
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 CodeStatusPrimary Contact

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Not yet recruiting
Name:
Phone:

Geolocation is 33.6834142, -117.9073244

Site
Costa Mesa
California
92626
Recruiting
Name:
Phone:

Geolocation is 32.8475528, -115.5694391

Site
Imperial
California
92251
Not yet recruiting
Name:
Phone:

Geolocation is 33.739744, -116.41279

Site
Rancho Mirage
California
92270
Not yet recruiting
Name:
Phone:

Geolocation is 33.7455731, -117.8678338

Site
Santa Ana
California
92705
Recruiting
Name:
Phone:

Geolocation is 34.2774306, -118.7897558

Site
Simi Valley
California
93065
Not yet recruiting
Name:
Phone:

Geolocation is 41.4305881, -72.9106202

Site
Hamden
Connecticut
06518
Recruiting
Name:
Phone:

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
Recruiting
Name:
Phone:

Geolocation is 41.3065186, -72.9310714

Site
New Haven
Connecticut
06520
Recruiting
Name:
Phone:

Geolocation is 26.5145591, -80.1540226

Site
Boynton Beach
Florida
33437
Recruiting
Name:
Phone:

Geolocation is 28.5552719, -82.3878709

Site
Brooksville
Florida
34601
Recruiting
Name:
Phone:

Geolocation is 26.2778269, -80.109357

Site
Deerfield Beach
Florida
33064
Recruiting
Name:
Phone:

Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Recruiting
Name:
Phone:

Geolocation is 25.9812024, -80.148379

Site
Hallandale Beach
Florida
33009
Recruiting
Name:
Phone:

Geolocation is 28.810823, -81.8778582

Site
Leesburg
Florida
34748
Not yet recruiting
Name:
Phone:

Geolocation is 28.9488761, -81.2986741

Site
Orange City
Florida
32763
Recruiting
Name:
Phone:

Geolocation is 26.5907805, -80.2432839

Site
Wellington
Florida
33449
Recruiting
Name:
Phone:

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Recruiting
Name:
Phone:

Geolocation is 33.7717008, -84.3726049

Site
Atlanta
Georgia
30308
Recruiting
Name:
Phone:

Geolocation is 33.9253024, -84.3857442

Site
Atlanta
Georgia
30328
Not yet recruiting
Name:
Phone:

Geolocation is 32.5371089, -84.9297206

Site
Columbus
Georgia
31909
Recruiting
Name:
Phone:

Geolocation is 42.0039178, -87.9703461

Site
Elk Grove Village
Illinois
60007
Not yet recruiting
Name:
Phone:

Geolocation is 39.7884076, -86.2869507

Site
Indianapolis
Indiana
46214
Recruiting
Name:
Phone:

Geolocation is 38.0369642, -84.5379455

Site
Lexington
Kentucky
40504
Not yet recruiting
Name:
Phone:

Geolocation is 30.2310081, -93.2190898

Site
Lake Charles
Louisiana
70629
Recruiting
Name:
Phone:

Geolocation is 30.2293526, -93.2131232

Site
Lake Charles
Louisiana
70601
Recruiting
Name:
Phone:

Geolocation is 39.2713976, -76.5603828

Site
Baltimore
Maryland
21224
Not yet recruiting
Name:
Phone:

Geolocation is 42.339904, -71.0898892

Site
Boston
Massachusetts
02115
Not yet recruiting
Name:
Phone:

Geolocation is 42.4500845, -73.2453824

Site
Pittsfield
Massachusetts
01201
Not yet recruiting
Name:
Phone:

Geolocation is 38.6608855, -90.422618

Site
Creve Coeur
Missouri
63141
Recruiting
Name:
Phone:

Geolocation is 38.767401, -90.4408037

Site
St. Louis
Missouri
63044
Recruiting
Name:
Phone:

Geolocation is 38.5844193, -90.2948797

Site
St. Louis
Missouri
63109
Not yet recruiting
Name:
Phone:

Geolocation is 40.7700703, -73.9580246

Site
New York
New York
10021
Recruiting
Name:
Phone:

Geolocation is 43.1301942, -77.6020569

Site
Rochester
New York
14620
Terminated
Name:
Phone:

Geolocation is 40.5944059, -74.0711359

Site
Staten Island
New York
10305
Recruiting
Name:
Phone:

Geolocation is 39.9990626, -83.0173386

Site
Columbus
Ohio
43210
Recruiting
Name:
Phone:

Geolocation is 40.1403357, -75.3995089

Site
Norristown
Pennsylvania
19403
Recruiting
Name:
Phone:

Geolocation is 39.9531865, -75.1749671

Site
Philadelphia
Pennsylvania
19103
Recruiting
Name:
Phone:

Geolocation is 32.7791432, -79.9248669

Site
Charleston
South Carolina
29401
Recruiting
Name:
Phone:

Geolocation is 35.1376546, -89.7661527

Site
Cordova
Tennessee
38018
Recruiting
Name:
Phone:

Geolocation is 30.3507705, -97.7362384

Site
Austin
Texas
78757
Recruiting
Name:
Phone:

Geolocation is 33.8954726, -98.544636

Site
Wichita Falls
Texas
76309
Recruiting
Name:
Phone:

Geolocation is 42.878094, -73.1968001

Site
Bennington
Vermont
05201
Recruiting
Name:
Phone:

Geolocation is 43.0972174, -89.5042876

Site
Middleton
Wisconsin
53562
Recruiting
Name:
Phone:

Geolocation is 43.0513426, -88.0411993

Site
Milwaukee
Wisconsin
53226
Not yet recruiting
Name:
Phone:

Geolocation is 43.0513426, -88.0411993

Site
Milwaukee
Wisconsin
53226
Recruiting
Name:
Phone:

Geolocation is 43.0116784, -88.2314813

Site
Waukesha
Wisconsin
53188
Recruiting
Name:
Phone:

Geolocation is 51.0647582, -114.1321594

Site
Calgary
Alberta
T2N 2T9
Not yet recruiting
Name:
Phone:

Geolocation is 45.0836805, -64.497142

Site
Kentville
Nova Scotia
B4N4K9
Not yet recruiting
Name:
Phone:

Geolocation is 44.2305468, -76.4840299

Site
Kingston
Ontario
K7L 5A2
Not yet recruiting
Name:
Phone:

Geolocation is 43.7215696, -79.3768256

Site
Toronto
Ontario
M4N 3M5
Not yet recruiting
Name:
Phone:

Geolocation is 45.4248921, -75.7406004

Site
Gatineau
Quebec
J9A 1K7
Not yet recruiting
Name:
Phone:

Geolocation is 45.542261, -73.6125451

Site
Montreal
Quebec
H2R 1V6
Not yet recruiting
Name:
Phone:

Geolocation is 50.4251547, -104.6054574

Site
Regina
Saskatchewan
S4S 0A5
Not yet recruiting
Name:
Phone:

Geolocation is 50.4542964, -104.6381398

Site
Regina
Saskatchewan
S4T 1A5
Not yet recruiting
Name:
Phone:

Geolocation is 50.4439999, -104.6012861

Site
Regina
Saskatchewan
S4P 0W5
Not yet recruiting
Name:
Phone:

Geolocation is 52.1293572, -106.6455187

Site
Saskatoon
Saskatchewan
S7N 0W8
Not yet recruiting
Name:
Phone:
Lead Sponsor: 
Agency
Pfizer
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
Pfizer CT.gov Call Center
Study Director
Pfizer
Study Contact: 
NamePhone
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: 
February 2016
Disease Stage: 
Early
Middle
Enrollment: 
342