A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
A PHASE 2 MULTICENTER, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY OF PF-04447943 IN SUBJECTS WITH MILD TO MODERATE ALZHEIMER'S DISEASE
2 other identifiers
interventional
191
4 countries
44
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2009
Shorter than P25 for phase_2
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedStudy Start
First participant enrolled
September 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 22, 2010
CompletedResults Posted
Study results publicly available
November 19, 2020
CompletedNovember 19, 2020
October 1, 2020
1 year
June 29, 2009
October 28, 2020
October 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) Score at Baseline
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.
Baseline (Day 1)
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale 70 (ADAS-Cog 70) at 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.
Baseline, Week 12
Secondary Outcomes (4)
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
Clinical Global Impression - Improvement (CGI-I)
Week 3, 6, 9, 12
Neuropsychiatric Inventory (NPI) Total Score at Baseline
Baseline
Change From Baseline in Neuropsychiatric Inventory (NPI) Total Score at Week 3, 6, 9 and 12
Baseline, Week 3, 6, 9, 12
Other Outcomes (6)
Number of Participants With Laboratory Test Abnormalities
Baseline up to Week 12
Number of Participants With Pre-defined Criteria for Electrocardiogram (ECG) Abnormalities
Baseline up to Week 12
Number of Participants With Abnormal Physical Examinations and Neurological Examinations
Screening (28 days before Baseline), Week 12
- +3 more other outcomes
Study Arms (2)
PF-04447943
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Mild to moderate Alzheimer's disease (MMSE 14-26)
- Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (44)
Neurology Clinic, PC
Northport, Alabama, 35476, United States
ATP Clinical Research, Inc.
Costa Mesa, California, 92626, United States
Southwestern Research Incorporated
Glendale, California, 91204, United States
Pacific Coast Imaging (for Imaging only)
Newport Beach, California, 92663, United States
The Southwest Institute for Clinical Research, Inc.
Rancho Mirage, California, 92270, United States
Pacific Research Network (Satellite Site)
San Diego, California, 92128, United States
Pacific Research Network, Inc. (Satellite Site)
Vista, California, 92081, United States
MD Clinical
Hallandale, Florida, 33009, United States
Compass Research, LLC
Orlando, Florida, 32806, United States
Berma Research Group
Plantation, Florida, 33317, United States
Joliet Center for Clinical Research
Joliet, Illinois, 60435, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46805, United States
Agewell
Indianapolis, Indiana, 46260, United States
Four Rivers Clinical Research, Inc.
Paducah, Kentucky, 42003, United States
Advanced MRI
Lake Charles, Louisiana, 70601, United States
Lake Charles Clinical Trials, LLC
Lake Charles, Louisiana, 70601, United States
Neurocare, Inc.
Newton, Massachusetts, 02459, United States
Neurobehavioral Research Inc
Cedarhurst, New York, 11516, United States
Behavioral Medical Research of Staten Island
Staten Island, New York, 10305, United States
University of Pittsburgh Alzheimer's Disease Research Center
Pittsburgh, Pennsylvania, 15213, United States
Rhode Island Hospital, Alzheimer's Disease and Memory Disorders Center
Providence, Rhode Island, 02903, United States
Neurology Clinic, PC
Cordova, Tennessee, 38018, United States
Medical Arts Health Research Group
Kelowna, British Columbia, V1Y 3G8, Canada
Hamilton Health Sciences
Hamilton, Ontario, L9C 7N4, Canada
Kawartha Regional Memory Clinic
Peterborough, Ontario, K9H 2P4, Canada
Neuro Rive Sud Clinic
Greenfield Park, Quebec, J4V 2J2, Canada
Diex Recherche Inc.
Sherbrooke, Quebec, J1H 1Z1, Canada
Psicomed Estudios Clinicos
Antofagasta, Antofagasta, Chile
Hospital Base Valdivia
Valdivia, Los Ríos Region, 5090145, Chile
Centro Doctora Lissette Duque
Providencia, RM, 7500617, Chile
Psicomedica Research Group
Santiago, RM, 7500710, Chile
Hospital Del Salvador
Santiago, RM, 7500922, Chile
Neuroconsult
Santiago, RM, 7550112, Chile
Especialidades Medicas L y S
Santiago, RM, 7560356, Chile
Neuropsicologia Ltda.
La Florida, Santiago Metropolitan, 8260094, Chile
Fakultni nemocnice
Hradec Králové, 500 05, Czechia
Pardubicka krajska nemocnice, a.s.
Pardubice, 53203, Czechia
Pragtis, s.r.o.
Prague, 120 00, Czechia
Fakultni nemocnice v Motole
Prague, 150 08, Czechia
Psychiatry Trial, s.r.o.
Prague, 15800, Czechia
Psychiatricka ambulance
Prague, 180 00, Czechia
Neurologie - EEG, s.r.o
Prague, 18000, Czechia
Centrum neurologicke pece, s.r.o.
Rychnov nad Kněžnou, 51601, Czechia
Psychiatricka ambulance
Strakonice, 386 01, Czechia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
September 10, 2009
Primary Completion
September 22, 2010
Study Completion
September 22, 2010
Last Updated
November 19, 2020
Results First Posted
November 19, 2020
Record last verified: 2020-10
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.