A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
- Registration Number
- NCT00930059
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to evaluate the effects of PF-04447943 compared to placebo on cognitive, behavioral and overall symptoms of Alzheimer's disease; evaluate the safety and tolerability of PF-0444793 compared to placebo; and determine the levels of PF-04447943 in the plasma over the course of the study.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 191
- Mild to moderate Alzheimer's disease (MMSE 14-26)
- Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)
- Use of acetylcholinesterase inhibitors (donepezil, rivastigmine, or galantamine) or memantine within 12 weeks of the start of the study
- Significant cardiovascular disease in the past 6 months
- Illness other than Alzheimer's disease that could contribute to cognitive impairment
- History of stroke or seizure disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - PF-04447943 PF-04447943 -
- Primary Outcome Measures
Name Time Method Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 12 Baseline, Week 12 ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline Baseline (Day 1) ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12 Baseline, Week 3, 6, 9, 12 NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.
Clinical Global Impression - Improvement (CGI-I) Week 3, 6, 9, 12 CGI-I is a 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale.
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at Week 3, 6 and 9 Baseline, Week 3, 6, 9 ADAS-cog is a structured scale assessing the severity of cognitive impairment in Alzheimer's disease. It comprises of following 11 items (range): word recall (0-10), naming objects and fingers (0-5), following commands (0-5), constructional praxis (0-5), ideational praxis (0-5), orientation (0-8), word recognition (0-12), recall of test instructions (0-5), spoken language ability (0-5), word-finding difficulty (0-5), comprehension of spoken language (0-5). Total ADAS-cog 70 score was sum of all items and ranged from 0 (least impairment) to 70 (most severe impairment), higher score indicating worse cognition.
Neuropsychiatric Inventory (NPI) Total Score at Baseline Baseline NPI total score evaluates disturbances in 12 behavioral domains: delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, motor disturbance, appetite/eating and night time behavior. NPI total score ranged from 0 (minimum severity) to 144 (maximum severity); higher score indicates greater behavioral disturbances.
Trial Locations
- Locations (42)
Lake Charles Clinical Trials, LLC
🇺🇸Lake Charles, Louisiana, United States
Neurocare, Inc.
🇺🇸Newton, Massachusetts, United States
Medical Arts Health Research Group
🇨🇦Kelowna, British Columbia, Canada
Centro Doctora Lissette Duque
🇨🇱Providencia, RM, Chile
Especialidades Medicas L y S
🇨🇱Santiago, RM, Chile
Neuropsicologia Ltda.
🇨🇱La Florida, Santiago, Chile
Hospital Base Valdivia
🇨🇱Valdivia, XIV Region, Chile
Fakultni nemocnice
🇨🇿Hradec Kralove, Czechia
Pardubicka krajska nemocnice, a.s.
🇨🇿Pardubice, Czechia
Psychiatry Trial, s.r.o.
🇨🇿Praha 5, Czechia
Pragtis, s.r.o.
🇨🇿Praha 2, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Neurologie - EEG, s.r.o
🇨🇿Praha 8, Czechia
Centrum neurologicke pece, s.r.o.
🇨🇿Rychnov nad Kneznou, Czechia
Psychiatricka ambulance
🇨🇿Strakonice, Czechia
Neurology Clinic, PC
🇺🇸Cordova, Tennessee, United States
Hospital Del Salvador
🇨🇱Santiago, RM, Chile
Neuro Rive Sud Clinic
🇨🇦Greenfield Park, Quebec, Canada
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Psicomedica Research Group
🇨🇱Santiago, RM, Chile
Kawartha Regional Memory Clinic
🇨🇦Peterborough, Ontario, Canada
Psicomed Estudios Clinicos
🇨🇱Antofagasta, II Region, Chile
Neuroconsult
🇨🇱Santiago, RM, Chile
Advanced MRI
🇺🇸Lake Charles, Louisiana, United States
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
Southwestern Research Incorporated
🇺🇸Glendale, California, United States
Pacific Research Network, Inc. (Satellite Site)
🇺🇸Vista, California, United States
Joliet Center for Clinical Research
🇺🇸Joliet, Illinois, United States
Fort Wayne Neurological Center
🇺🇸Fort Wayne, Indiana, United States
Four Rivers Clinical Research, Inc.
🇺🇸Paducah, Kentucky, United States
Neurobehavioral Research Inc
🇺🇸Cedarhurst, New York, United States
Rhode Island Hospital, Alzheimer's Disease and Memory Disorders Center
🇺🇸Providence, Rhode Island, United States
Agewell
🇺🇸Indianapolis, Indiana, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
Pacific Coast Imaging (for Imaging only)
🇺🇸Newport Beach, California, United States
Pacific Research Network (Satellite Site)
🇺🇸San Diego, California, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Berma Research Group
🇺🇸Plantation, Florida, United States
Behavioral Medical Research of Staten Island
🇺🇸Staten Island, New York, United States
University of Pittsburgh Alzheimer's Disease Research Center
🇺🇸Pittsburgh, Pennsylvania, United States
Diex Recherche Inc.
🇨🇦Sherbrooke, Quebec, Canada
The Southwest Institute for Clinical Research, Inc.
🇺🇸Rancho Mirage, California, United States