Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil
NCT01712074
Last updated date
ABOUT THIS STUDY
This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate
Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil.
The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered
the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and
neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor
re-emergence of neuropsychiatric and cognitive symptoms.
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
60 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Clinical diagnosis of probable AD with supportive brain imaging documentation
- Have existing neuropsychiatric symptoms as defined by a score equal or greater than 10 on the NPI at screening, arising from item scores equal or greater than 2 (frequency X severity) on at least 2 domains.
- Has been on donepezil (stable dose of 5 mg or 10 mg) for at least four months, with no intent to change such for the duration of the study.
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Demonstrate extreme agitation, physical aggression or violence to themselves, their
caregiver, or others, and/or an inability to complete the ADAS-cog assessment at
Screening.
- Have major structural brain disease other than Alzheimer's Disease
- Other severe acute or chronical medical or psychiatric condition or laboratory
abnormality
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
Clinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Alzheimer's DiseaseBapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)
NCT00574132
- Birmingham, Alabama
- Goodyear, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Sun City, Arizona
- Tucson, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Berkeley, California
- Carson, California
- Costa Mesa, California
- Encino, California
- Fresno, California
- Fullerton, California
- Glendale, California
- Imperial, California
- La Jolla, California
- La Jolla, California
- Laguna Hills, California
- Long Beach, California
- Los Alamitos, California
- Los Angeles, California
- Los Angeles, California
- National City, California
- Newport Beach, California
- Oceanside, California
- Orange, California
- Pasadena, California
- Rancho Mirage, California
- Sacramento, California
- Sacramento, California
- San Diego, California
- San Diego, California
- San Francisco, California
- San Francisco, California
- Santa Ana, California
- Santa Monica, California
- Sherman Oaks, California
- Walnut Creek, California
- Boulder, Colorado
- Denver, Colorado
- Fort Collins, Colorado
- Danbury, Connecticut
- Fairfield, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- Norwalk, Connecticut
- Waterbury, Connecticut
- Newark, Delaware
- Washington, District of Columbia
- Atlantis, Florida
- Bradenton, Florida
- Deerfield Beach, Florida
- Delray Beach, Florida
- Fort Lauderdale, Florida
- Fort Myers, Florida
- Fort Walton Beach, Florida
- Ft. Myers, Florida
- Hallandale Beach, Florida
- Hollywood, Florida
- Jacksonville, Florida
- Maitland, Florida
- Melbourne, Florida
- Miami, Florida
- Miami, Florida
- Miami, Florida
- Ocala, Florida
- Orange City, Florida
- Orlando, Florida
- Palm Beach Gardens, Florida
- Pembroke Pines, Florida
- Port Charlotte, Florida
- Sarasota, Florida
- South Miami, Florida
- St Petersburg, Florida
- St. Petersburg, Florida
- Tampa, Florida
- Tampa, Florida
- Tampa, Florida
- Tampa, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Columbus, Georgia
- Decatur, Georgia
- Lawrenceville, Georgia
- Chicago, Illinois
- Chicago, Illinois
- Elk Grove Village, Illinois
- Peoria, Illinois
- Springfield, Illinois
- Elkhart, Indiana
- Fort Wayne, Indiana
- Indianapolis, Indiana
- Kansas City, Kansas
- Kansas City, Kansas
- Lenexa, Kansas
- Lexington, Kentucky
- Lexington, Kentucky
- Paducah, Kentucky
- Lake Charles, Louisiana
- New Orleans, Louisiana
- Shreveport, Louisiana
- Shreveport, Louisiana
- Scarborough, Maine
- Baltimore, Maryland
- Baltimore, Maryland
- Rockville, Maryland
- Belmont, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Haverhill, Massachusetts
- Newton, Massachusetts
- Pittsfield, Massachusetts
- Plymouth, Massachusetts
- Springfield, Massachusetts
- Springfield, Massachusetts
- Weymouth, Massachusetts
- Ann Arbor, Michigan
- Detroit, Michigan
- East Lansing, Michigan
- Grand Rapids, Michigan
- Kalamazoo, Michigan
- Rochester, Minnesota
- Flowood, Mississippi
- Hattiesburg, Mississippi
- Kansas City, Missouri
- Kansas City, Missouri
- St. Louis, Missouri
- St. Louis, Missouri
- Billings, Montana
- Great Falls, Montana
- Omaha, Nebraska
- Las Vegas, Nevada
- Dover, New Hampshire
- Lebanon, New Hampshire
- Berlin, New Jersey
- Eatontown, New Jersey
- Manchester, New Jersey
- Mount Arlington, New Jersey
- Princeton, New Jersey
- Stratford, New Jersey
- Toms River, New Jersey
- Albuquerque, New Mexico
- Albuquerque, New Mexico
- Albany, New York
- Albany, New York
- Albany, New York
- Brooklyn, New York
- Cedarhurst, New York
- Elmsford, New York
- Latham, New York
- Liverpool, New York
- New Hyde Park, New York
- New York, New York
- New York, New York
- New York, New York
- New York, New York
- Orangeburg, New York
- Rochester, New York
- Durham, North Carolina
- Hickory, North Carolina
- Hickory, North Carolina
- Raleigh, North Carolina
- Winston-Salem, North Carolina
- Beachwood, Ohio
- Canton, Ohio
- Canton, Ohio
- Cleveland, Ohio
- Columbus, Ohio
- Dayton, Ohio
- Toledo, Ohio
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Medford, Oregon
- Portland, Oregon
- Portland, Oregon
- Portland, Oregon
- Abington, Pennsylvania
- Allentown, Pennsylvania
- Jenkintown, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Pittsburg, Pennsylvania
- East Providence, Rhode Island
- Providence, Rhode Island
- Providence, Rhode Island
- N. Charleston, South Carolina
- Sioux Falls, South Dakota
- Cordova, Tennessee
- Franklin, Tennessee
- Johnson City, Tennessee
- Knoxville, Tennessee
- Austin, Texas
- Dallas, Texas
- Dallas, Texas
- DeSoto, Texas
- Fort Worth, Texas
- Houston, Texas
- Houston, Texas
- San Antonio, Texas
- San Antonio, Texas
- Wichita Falls, Texas
- Salt Lake City, Utah
- Salt Lake City, Utah
- Bennington, Vermont
- Burlington, Vermont
- Alexandria, Virginia
- Charlottesville, Virginia
- Richmond, Virginia
- Seattle, Washington
- Seattle, Washington
- Wenatchee, Washington
- Madison, Wisconsin
- Milwaukee, Wisconsin
- Waukesha, Wisconsin
- Graz, Styria
- Wien, Vienna
- Calgary, Alberta
- Kamloops, British Columbia
- Kelowna, British Columbia
- Penticton, British Columbia
- Vancouver, British Columbia
- Kingston, Ontario
- London, Ontario
- London, Ontario
- Ottawa, Ontario
- Peterborough, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Whitby, Ontario
- Greenfield Park, Quebec
- Montreal, Quebec
- Montréal, Quebec
- Sherbrooke, Quebec
- Verdun, Quebec
- Tübingen, Baden-wuerttemberg
- Ulm, Baden-wuerttemberg
- Freiburg, Baden-Württemberg
- Günzburg, Bayern
- München, Bayern
- München, Bayern
- Regensburg, Byern
- Bochum, Nordrhein-westfalen
- Homburg/Saar, Saarland
- Leipzig, Sachen
- Dresden, Saschen
- Hamburg,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Alzheimer's DiseaseA Long-Term Safety and Tolerability Study in Subjects With Mild to Moderate Alzheimer's Disease
NCT00937352
- Birmingham, Alabama
- Goodyear, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Sun City, Arizona
- Tucson, Arizona
- Tucson, Arizona
- Little Rock, Arkansas
- Berkeley, California
- Carson, California
- Costa Mesa, California
- Encino, California
- Fresno, California
- Fullerton, California
- La Jolla, California
- La Jolla, California
- Laguna Hills, California
- Long Beach, California
- Los Alamitos, California
- Los Angeles, California
- Newport Beach, California
- Oceanside, California
- Orange, California
- Pasadena, California
- Sacramento, California
- Sacramento, California
- San Diego, California
- San Diego, California
- San Francisco, California
- San Francisco, California
- Santa Monica, California
- Sherman Oaks, California
- Walnut Creek, California
- Boulder, Colorado
- Denver, Colorado
- Fort Collins, Colorado
- Danbury, Connecticut
- Fairfield, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- Norwalk, Connecticut
- Waterbury, Connecticut
- Newark, Delaware
- Washington, District of Columbia
- Atlantis, Florida
- Bradenton, Florida
- Deerfield Beach, Florida
- Delray Beach, Florida
- Fort Lauderdale, Florida
- Fort Myers, Florida
- Fort Myers, Florida
- Fort Walton Beach, Florida
- Hallandale Beach, Florida
- Jacksonville, Florida
- Maitland, Florida
- Melbourne, Florida
- Miami, Florida
- Miami, Florida
- Miami, Florida
- Miami, Florida
- Ocala, Florida
- Orlando, Florida
- Palm Beach Gardens, Florida
- Port Charlotte, Florida
- Saint Petersburg, Florida
- Sarasota, Florida
- Tampa, Florida
- Tampa, Florida
- Tampa, Florida
- Tampa, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Atlanta, Georgia
- Atlanta, Georgia
- Columbus, Georgia
- Columbus, Georgia
- Decatur, Georgia
- Lawrenceville, Georgia
- Chicago, Illinois
- Elk Grove Village, Illinois
- Peoria, Illinois
- Springfield, Illinois
- Elkhart, Indiana
- Indianapolis, Indiana
- Kansas City, Kansas
- Lenexa, Kansas
- Lexington, Kentucky
- Lexington, Kentucky
- Paducah, Kentucky
- Lake Charles, Louisiana
- Shreveport, Louisiana
- Scarborough, Maine
- Rockville, Maryland
- Boston, Massachusetts
- Boston, Massachusetts
- Haverhill, Massachusetts
- Newton, Massachusetts
- Pittsfield, Massachusetts
- Plymouth, Massachusetts
- Springfield, Massachusetts
- Ann Arbor, Michigan
- Detroit, Michigan
- East Lansing, Michigan
- Kalamazoo, Michigan
- Rochester, Minnesota
- Hattiesburg, Mississippi
- Kansas City, Missouri
- Saint Louis, Missouri
- Saint Lous, Missouri
- Billings, Montana
- Great Falls, Montana
- Omaha, Nebraska
- Eatontown, New Jersey
- Manchester, New Jersey
- Princeton, New Jersey
- Toms River, New Jersey
- Albuquerque, New Mexico
- Albany, New York
- Albany, New York
- Albany, New York
- Elmsford, New York
- Latham, New York
- Liverpool, New York
- New Hyde Park, New York
- New York, New York
- New York, New York
- Orangeburg, New York
- Rochester, New York
- Durham, North Carolina
- Hickory, North Carolina
- Raleigh, North Carolina
- Canton, Ohio
- Columbus, Ohio
- Dayton, Ohio
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Medford, Oregon
- Portland, Oregon
- Portland, Oregon
- Portland, Oregon
- Abington, Pennsylvania
- Allentown, Pennsylvania
- Jenkintown, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Pittsburgh, Pennsylvania
- East Providence, Rhode Island
- Providence, Rhode Island
- Providence, Rhode Island
- North Charleston, South Carolina
- Sioux Falls, South Dakota
- Cordova, Tennessee
- Johnson City, Tennessee
- Knoxville, Tennessee
- Nashville, Tennessee
- Austin, Texas
- Dallas, Texas
- Dallas, Texas
- DeSoto, Texas
- Fort Worth, Texas
- Houston, Texas
- San Antonio, Texas
- San Antonio, Texas
- Salt Lake City, Utah
- Salt Lake City, Utah
- Bennington, Vermont
- Burlington, Vermont
- Alexandria, Virginia
- Charlottesville, Virginia
- Richmond, Virginia
- Seattle, Washington
- Seattle, Washington
- Milwaukee, Wisconsin
- Waukesha, Wisconsin
- Graz, Styria
- Calgary, Alberta
- Kamloops, British Columbia
- Kelowna, British Columbia
- Kingston, Ontario
- London, Ontario
- Ottawa, Ontario
- Toronto, Ontario
- Toronto, Ontario
- Whitby, Ontario
- Greenfield Park, Quebec
- Montréal, Quebec
- Montréal, Quebec
- Sherbrooke, Quebec
- Verdun, Quebec
ALL GENDERS
51 Years+
years
MULTIPLE SITES
Alzheimer's DiseaseDetection of Disease-Related Changes in Pre-Symptomatic Alzheimer's Disease
NCT01841905
- Providence, Rhode Island
ALL GENDERS
55 Years+
years
MULTIPLE SITES
Alzheimer's DiseaseAAB-001 in Patients With Mild to Moderate Alzheimer's Disease
NCT00112073
- Sun City, Arizona
- Irvine, California
- Los Alamitos, California
- Northridge, California
- San Diego, California
- San Francisco, California
- New Haven, Connecticut
- Washington, District of Columbia
- Delray Beach, Florida
- Jacksonville, Florida
- Chicago, Illinois
- Indianapolis, Indiana
- Boston, Massachusetts
- Ann Arbor, Michigan
- Rochester, Minnesota
- Long Branch, New Jersey
- New York City, New York
- Rochester, New York
- Durham, North Carolina
- Portland, Oregon
- Pittsburgh, Pennsylvania
- Providence, Rhode Island
- Dallas, Texas
- Houston, Texas
- Bennington, Vermont
- Seattle, Washington
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil | |||
| Official Title ICMJE | 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 Donepezil | |||
| Brief Summary | This study will evaluate safety and efficacy of PF-05212377 in subjects with mild-to-moderate Alzheimer's Disease with existing neuropsychiatric symptoms on a stable dose of Donepezil. The 4-week run-in will minimize placebo effect. The 12-week treatment period is considered the minimum length necessary to reliably evaluate the effect PF-05212377 on cognition and and neuropsychiatric symptoms in this population. The 2-week washout will allow to monitor re-emergence of neuropsychiatric and cognitive symptoms. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | |||
| Condition ICMJE | Alzheimer's Disease | |||
| Intervention ICMJE |
| |||
| Study Arms ICMJE |
| |||
| Publications * | Fullerton T, Binneman B, David W, Delnomdedieu M, Kupiec J, Lockwood P, Mancuso J, Miceli J, Bell J. A Phase 2 clinical trial of PF-05212377 (SAM-760) in subjects with mild to moderate Alzheimer's disease with existing neuropsychiatric symptoms on a stable daily dose of donepezil. Alzheimers Res Ther. 2018 Apr 5;10(1):38. doi: 10.1186/s13195-018-0368-9. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 186 | |||
| Original Estimated Enrollment ICMJE | 342 | |||
| Actual Study Completion Date ICMJE | September 2015 | |||
| Actual Primary Completion Date | September 2015 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 60 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Canada, Chile, France, Germany, Spain, United Kingdom, United States | |||
| Removed Location Countries | Australia | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT01712074 | |||
| Other Study ID Numbers ICMJE | B2081011 2014-000830-42 ( EudraCT Number ) | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Pfizer | |||
| Verification Date | January 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||