Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers
NCT01005862
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Males or females of non-childbearing potential (age 50 and over for Alzheimer's disease patients; 21-45 for healthy volunteers)
- For patients with Alzheimer's Disease: Diagnosis of probable Alzheimer's disease, consistent with criteria from both National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
- Mini-mental status exam score greater than or equal to 20
- Rosen-Modified Hachinski Ischemia Score of < or = 4
- On stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment
- Diagnosis or history of other demential or neurodegenerative disorders
- Diagnosis or history of clinically significant cerebrovascular disease
- Specific findings on magnetic resonance imaging (MRI); cortical infarct, micro
hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
- History of autoimmune disorders
- History of allergic or anaphylactic reactions
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
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
- 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,
- 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
- Providence, Rhode Island
- 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
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers | |||
Official Title ICMJE | A Randomized, Investigator And Subject-Blind, Sponsor-Open, Placebo-Controlled Study To Examine The Effects Of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers | |||
Brief Summary | The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Primary Purpose: Treatment | |||
Condition ICMJE | Alzheimer's Disease | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* 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 | Completed | |||
Actual Enrollment ICMJE | 17 | |||
Original Estimated Enrollment ICMJE | 18 | |||
Actual Study Completion Date ICMJE | September 2012 | |||
Actual Primary Completion Date | September 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 21 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Sweden, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01005862 | |||
Other Study ID Numbers ICMJE | A9951011 | |||
Has Data Monitoring Committee | No | |||
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 | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |