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 33.6834142, -117.9073244

Site
Costa Mesa
California
92626
Recruiting
Name:
Phone:

Geolocation is 32.8491869, -115.7338502

Site
Imperial
California
92251
Recruiting
Name:
Phone:

Geolocation is 33.739744, -116.41279

Site
Rancho Mirage
California
92270
Recruiting
Name:
Phone:

Geolocation is 33.7455731, -117.8678338

Site
Santa Ana
California
92705
Recruiting
Name:
Phone:

Geolocation is 41.4305881, -72.9106202

Site
Hamden
Connecticut
06518
Recruiting
Name:
Phone:

Geolocation is 41.3065186, -72.9310714

Site
New Haven
Connecticut
06520
Recruiting
Name:
Phone:

Geolocation is 41.3052226, -72.9268626

Site
New Haven
Connecticut
06510
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
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
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
Recruiting
Name:
Phone:

Geolocation is 39.7884076, -86.2869507

Site
Indianapolis
Indiana
46214
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
Recruiting
Name:
Phone:

Geolocation is 42.4500845, -73.2453824

Site
Pittsfield
Massachusetts
01201
Recruiting
Name:
Phone:

Geolocation is 42.7247832, -84.4832117

Site
East Lansing
Michigan
48824
Recruiting
Name:
Phone:

Geolocation is 38.6608855, -90.422618

Site
Creve Coeur
Missouri
63141
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