Study Evaluating TheSafety And Efficacy Of PF-05212377 Or Placebo In Subjects With Alzheimer's Disease With Existing Neuropsychiatric Symptoms On Donepezil
- Conditions
- Alzheimer's Disease
- Interventions
- Other: Placebo
- Registration Number
- NCT01712074
- Lead Sponsor
- Pfizer
- 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 available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 186
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 30 mg QD of PF-05212377 PF-05212377 (SAM-760) - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Change From Baseline in ADAS-cog13 Total Score at Week 16 Baseline and Week 16 ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening.
- Secondary Outcome Measures
Name Time Method Change From Baseline in the Neuropsychiatric Inventory (NPI) Total Score at Week 16 (Visit 5) Baseline and Week 16 The NPI evaluates both frequency and severity of 12 neuropsychiatric disturbances including delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, nighttime behaviors, as well as appetite/eating. The NPI total score (for 12 behavioral domains) is calculated as the product of frequency and severity for each domain, and ranges from 0 to 144. An increase in score indicates a worsening of symptoms.
Trial Locations
- Locations (60)
Espace Sante 2
🇫🇷La Seyne Sur Mer, France
Fulbourn Hospital
🇬🇧Cambridge, United Kingdom
Hospital de Cantoblanco
🇪🇸Madrid, Spain
Praxis Dr. sc. med. Alexander Schulze
🇩🇪Berlin, Germany
Arzneimittelforschung Leipzig Gmbh
🇩🇪Leipzig, Germany
The Research Institute for the Care of Older People Centre
🇬🇧Bath, United Kingdom
Covance Laboratories
🇬🇧Switzerland, United Kingdom
Praxis fuer Neurologie / Psychiatrie Prof. Dr. Steinwachs
🇩🇪Nuernberg, Germany
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
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Quantum Laboratories
🇺🇸Deerfield Beach, Florida, United States
Brain Matters Research Inc
🇺🇸Delray Beach, Florida, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
The Ohio State University (administrative offices only)
🇺🇸Columbus, Ohio, United States
The Ohio State University - 2050
🇺🇸Columbus, Ohio, United States
Surrey and Borders Partnership NHS Foundation Trust
🇬🇧Chertsey, United Kingdom
Recherches Neuro-Hippocampe Inc.
🇨🇦Gatineau, Quebec, Canada
Geriatric and Adult Psychiatry LLC
🇺🇸Hamden, Connecticut, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Diagnostic Centers of America
🇺🇸Boynton Beach, Florida, United States
Compass Research LLC-North Clinic
🇺🇸Leesburg, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
Columbus Research & Wellness Institute, Inc.
🇺🇸Columbus, Georgia, 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
Keystone Clinical Studies, LLC
🇺🇸Norristown, Pennsylvania, United States
Neurology Clinic, P.C.
🇺🇸Cordova, Tennessee, United States
Senior Adults Speciality Research Inc.
🇺🇸Austin, Texas, United States
Dean Foundation for Health, Research and Education
🇺🇸Middleton, Wisconsin, United States
Merrill Hills Manor
🇺🇸Waukesha, Wisconsin, United States
Chatham-kent Clinical Trials Research Centre
🇨🇦Chatham, Ontario, Canada
True North Clinical Research Halifax, Inc.
🇨🇦Halifax, Nova Scotia, Canada
Especialidades Medicas L Y S
🇨🇱Santiago, Metropolitana, Chile
Psicomed Estudios Medicos CIA. LTDA
🇨🇱Antofagasta, Ii Region, Chile
Biomedica Research Group
🇨🇱Santiago, Metropolitana, Chile
Dr. med. Volker Schumann, Arzt fuer Nervenheilkunde
🇩🇪Berlin, Germany
Praxis Dr. Franz- Arztehaus am KEH mit Epilepsie-Zentrum
🇩🇪Berlin, Germany
Berrywood Hospital
🇬🇧Northampton, United Kingdom
Institute for Advanced Medical Research
🇺🇸Alpharetta, Georgia, 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
Cary J. Kohlenberg, MD, dba, IPC Research
🇺🇸Waukesha, Wisconsin, 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
Hospital General Universitario De Elche
🇪🇸Elche, Alicante, Spain
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
Chatham-Kent Clinical Trials Research Centre
🇨🇦Chatham, Ontario, Canada