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 Age | Max Age | Gender | Healthy 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 | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 33.4636012, -112.0535987 | Phoenix | Arizona | 85006 | Not yet recruiting | Name: Phone: | |
Geolocation is 33.6834142, -117.9073244 | Costa Mesa | California | 92626 | Recruiting | Name: Phone: | |
Geolocation is 41.4305881, -72.9106202 | Hamden | Connecticut | 06518 | Recruiting | Name: Phone: | |
Geolocation is 41.3052226, -72.9268626 | New Haven | Connecticut | 06510 | Not yet recruiting | Name: Phone: | |
Geolocation is 28.5552719, -82.3878709 | Brooksville | Florida | 34601 | Recruiting | Name: Phone: | |
Geolocation is 26.2778269, -80.109357 | Deerfield Beach | Florida | 33064 | Recruiting | Name: Phone: | |
Geolocation is 26.4647478, -80.109357 | Delray Beach | Florida | 33445 | Recruiting | Name: Phone: | |
Geolocation is 25.9812024, -80.148379 | Hallandale Beach | Florida | 33009 | Recruiting | Name: Phone: | |
Geolocation is 27.9407591, -82.5104655 | Tampa | Florida | 33609 | Recruiting | Name: Phone: | |
Geolocation is 26.7619563, -80.1037721 | West Palm Beach | Florida | 33407 | Recruiting | Name: Phone: | |
Geolocation is 33.7717008, -84.3726049 | Atlanta | Georgia | 30308 | Recruiting | Name: Phone: | |
Geolocation is 30.2310081, -93.2190898 | Lake Charles | Louisiana | 70629 | Recruiting | Name: Phone: | |
Geolocation is 38.6608855, -90.422618 | Creve Coeur | Missouri | 63141 | Not yet recruiting | Name: Phone: | |
Geolocation is 38.767401, -90.4408037 | St. Louis | Missouri | 63044 | Not yet recruiting | Name: Phone: | |
Geolocation is 43.1301942, -77.6020569 | Rochester | New York | 14620 | Not yet recruiting | Name: Phone: | |
Geolocation is 40.1403357, -75.3995089 | Norristown | Pennsylvania | 19403 | Not yet recruiting | Name: Phone: | |
Geolocation is 35.1376546, -89.7661527 | Cordova | Tennessee | 38018 | Recruiting | Name: Phone: | |
Geolocation is 30.3507705, -97.7362384 | Austin | Texas | 78757 | Recruiting | Name: Phone: | |
Geolocation is 33.8954726, -98.544636 | Wichita Falls | Texas | 76309 | Not yet recruiting | Name: Phone: | |
Geolocation is 42.878094, -73.1968001 | Bennington | Vermont | 05201 | Not yet recruiting | Name: Phone: | |
Geolocation is 43.0972174, -89.5042876 | Middleton | Wisconsin | 53562 | Not yet recruiting | Name: Phone: | |
Geolocation is 43.0513426, -88.0411993 | Milwaukee | Wisconsin | 53226 | Recruiting | Name: Phone: | |
Geolocation is 43.0116784, -88.2314813 | Waukesha | Wisconsin | 53188 | Recruiting | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
Pfizer |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Pfizer CT.gov Call Center | Study Director | Pfizer |
Study Contact:
| Name | Phone |
|---|---|
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:
April 2014
Disease Stage:
Early
Middle
Enrollment:
342
