Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil
NCT ID: NCT01712074
Last Updated: 2017-03-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
186 participants
INTERVENTIONAL
2012-11-30
2015-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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30 mg QD of PF-05212377
PF-05212377 (SAM-760)
30 mg QD of PF-05212377 (SAM-760)
Placebo
Placebo
Placebo QD
Interventions
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PF-05212377 (SAM-760)
30 mg QD of PF-05212377 (SAM-760)
Placebo
Placebo QD
Eligibility Criteria
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Inclusion Criteria
* 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
* Have major structural brain disease other than Alzheimer's Disease
* Other severe acute or chronical medical or psychiatric condition or laboratory abnormality
60 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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ATP Clinical Research, Inc
Costa Mesa, California, United States
Sun Valley Research Center
Imperial, California, United States
Desert Valley Research
Rancho Mirage, California, United States
RAA - Apex Aquisition, LLC
Santa Ana, California, United States
Geriatric and Adult Psychiatry LLC
Hamden, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Yale-New Haven Hospital, Temple Radiology
New Haven, Connecticut, United States
Yale University School of Medicine, MRI Research Center (MRI)
New Haven, Connecticut, United States
Diagnostic Centers of America
Boynton Beach, Florida, United States
Meridien Research
Brooksville, Florida, United States
Quantum Laboratories
Deerfield Beach, Florida, United States
Brain Matters Research Inc
Delray Beach, Florida, United States
MD Clinical
Hallandale, Florida, United States
Compass Research LLC-North Clinic
Leesburg, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, United States
Atlanta Center for Medical Research
Atlanta, Georgia, United States
Columbus Research & Wellness Institute, Inc.
Columbus, Georgia, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
Michigan State University
East Lansing, Michigan, United States
Metro Imaging (Imaging only)
Creve Coeur, Missouri, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, United States
University of Rochester Medical Center AD-CARE Program | University of Rochester Medical Center
Rochester, New York, United States
University of Rochester Medical Center (MRI Imaging Only)
Rochester, New York, United States
Behavioral Medical Research of Staten Island
Staten Island, New York, United States
The Ohio State University (administrative offices only)
Columbus, Ohio, United States
The Ohio State University - 2050
Columbus, Ohio, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States
Roper Hospital (Imaging Only)
Charleston, South Carolina, United States
Roper St. Francis Healthcare
Charleston, South Carolina, United States
Roper St. Francis Pharmacy (IP Shipment/Storage)
Charleston, South Carolina, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Senior Adults Speciality Research Inc.
Austin, Texas, United States
Grayline Clinical Drug Trials
Wichita Falls, Texas, United States
Clinical Neuroscience Research Assoc. d/b/a The Memory Clinic
Bennington, Vermont, United States
Dean Foundation for Health, Research and Education
Middleton, Wisconsin, United States
Cary J. Kohlenberg, MD, dba, IPC Research
Waukesha, Wisconsin, United States
Merrill Hills Manor
Waukesha, Wisconsin, United States
True North Clinical Research Halifax, Inc.
Halifax, Nova Scotia, Canada
Chatham-kent Clinical Trials Research Centre
Chatham, Ontario, Canada
Chatham-Kent Clinical Trials Research Centre
Chatham, Ontario, Canada
Recherches Neuro-Hippocampe Inc.
Gatineau, Quebec, Canada
Psicomed Estudios Medicos CIA. LTDA
Antofagasta, Antofagasta, Chile
Biomedica Research Group
Santiago, Santiago Metropolitan, Chile
Especialidades Medicas L Y S
Santiago, Santiago Metropolitan, Chile
Espace Sante 2
La Seyne-sur-Mer, , France
Dr. med. Volker Schumann, Arzt fuer Nervenheilkunde
Berlin, , Germany
Praxis Dr. Franz- Arztehaus am KEH mit Epilepsie-Zentrum
Berlin, , Germany
Praxis Dr. sc. med. Alexander Schulze
Berlin, , Germany
Arzneimittelforschung Leipzig Gmbh
Leipzig, , Germany
Praxis fuer Neurologie / Psychiatrie Prof. Dr. Steinwachs
Nuremberg, , Germany
Hospital General Universitario De Elche
Elche, Alicante, Spain
Hospital de Cantoblanco
Madrid, Madrid, Spain
The Research Institute for the Care of Older People Centre
Bath, , United Kingdom
Fulbourn Hospital
Cambridge, , United Kingdom
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, , United Kingdom
Berrywood Hospital
Northampton, , United Kingdom
Covance Laboratories
Switzerland, , United Kingdom
Countries
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References
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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.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2014-000830-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
B2081011
Identifier Type: -
Identifier Source: org_study_id
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