A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00930059
First received: June 29, 2009
Last updated: April 9, 2013
Last verified: April 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: PF-04447943 Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Phase 2 Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study Of PF-04447943 In Subjects With Mild To Moderate Alzheimer's Disease |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Change from baseline on Alzheimer's Disease Assessment Scale (Cognitive Subscale) [ Time Frame: screen, baseline, wks 3, 6, 9, 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline on Neuropsychiatric Inventory [ Time Frame: screen, baseline, wks 3, 6, 9, 12 ] [ Designated as safety issue: No ]
- Clinical Global Impression - Improvement [ Time Frame: wks 3, 6, 9, 12 ] [ Designated as safety issue: No ]
- Safety Assessments (including adverse events, vital signs, electrocardiograms, laboratory tests) [ Time Frame: screen, baseline, weeks 1, 3, 6, 9, 12 ] [ Designated as safety issue: Yes ]
- Plasma Concentrations of PF-04447943 [ Time Frame: wks 1, 3, 6, 9, 12 ] [ Designated as safety issue: No ]
| Enrollment: | 198 |
| Study Start Date: | September 2009 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PF-04447943 |
Drug: PF-04447943
tablets, 25 mg every 12 hours for 12 wks
|
| Placebo Comparator: Placebo |
Drug: Placebo
matching placebo tablets, every 12 hours for 12 wks
|
Eligibility| Ages Eligible for Study: | 55 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Mild to moderate Alzheimer's disease (MMSE 14-26)
- Good general health (such controlled conditions as Type 2 diabetes and hypertension allowed)
Exclusion Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930059
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| United States, Alabama | |
| Pfizer Investigational Site | |
| Northport, Alabama, United States, 35476 | |
| United States, California | |
| Pfizer Investigational Site | |
| Costa Mesa, California, United States, 92626 | |
| Pfizer Investigational Site | |
| Glendale, California, United States, 91204 | |
| Pfizer Investigational Site | |
| Newport Beach, California, United States, 92663 | |
| Pfizer Investigational Site | |
| Rancho Mirage, California, United States, 92270 | |
| Pfizer Investigational Site | |
| San Diego, California, United States, 92128 | |
| Pfizer Investigational Site | |
| Vista, California, United States, 92081 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Hallandale Beach, Florida, United States, 33009 | |
| Pfizer Investigational Site | |
| Orlando, Florida, United States, 32806 | |
| Pfizer Investigational Site | |
| Plantation, Florida, United States, 33317 | |
| United States, Illinois | |
| Pfizer Investigational Site | |
| Joliet, Illinois, United States, 60435 | |
| United States, Indiana | |
| Pfizer Investigational Site | |
| Fort Wayne, Indiana, United States, 46805 | |
| Pfizer Investigational Site | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Paducah, Kentucky, United States, 42003 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Lake Charles, Louisiana, United States, 70601 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | |
| Newton, Massachusetts, United States, 02459 | |
| United States, New York | |
| Pfizer Investigational Site | |
| Cedarhurst, New York, United States, 11516 | |
| Pfizer Investigational Site | |
| Staten Island, New York, United States, 10305 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | |
| Providence, Rhode Island, United States, 02903 | |
| United States, Tennessee | |
| Pfizer Investigational Site | |
| Cordova, Tennessee, United States, 38018 | |
| Canada, British Columbia | |
| Pfizer Investigational Site | |
| Kelowna, British Columbia, Canada, V1Y 3G8 | |
| Canada, Ontario | |
| Pfizer Investigational Site | |
| Hamilton, Ontario, Canada, L9C 7N4 | |
| Pfizer Investigational Site | |
| Peterborough, Ontario, Canada, K9H 2P4 | |
| Canada, Quebec | |
| Pfizer Investigational Site | |
| Greenfield Park, Quebec, Canada, J4V 2J2 | |
| Pfizer Investigational Site | |
| Sherbrooke, Quebec, Canada, J1H 1Z1 | |
| Chile | |
| Pfizer Investigational Site | |
| Antofagasta, II Region, Chile | |
| Pfizer Investigational Site | |
| Providencia, RM, Chile, 7500617 | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile, 7500710 | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile, 7560356 | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile, 7550112 | |
| Pfizer Investigational Site | |
| Santiago, RM, Chile, 7500922 | |
| Pfizer Investigational Site | |
| La Florida, Santiago, Chile, 8260094 | |
| Pfizer Investigational Site | |
| Valdivia, XIV Region, Chile, 5090145 | |
| Czech Republic | |
| Pfizer Investigational Site | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Pfizer Investigational Site | |
| Pardubice, Czech Republic, 53203 | |
| Pfizer Investigational Site | |
| Praha 2, Czech Republic, 120 00 | |
| Pfizer Investigational Site | |
| Praha 5, Czech Republic, 15800 | |
| Pfizer Investigational Site | |
| Praha 5, Czech Republic, 150 08 | |
| Pfizer Investigational Site | |
| Praha 8, Czech Republic, 18000 | |
| Pfizer Investigational Site | |
| Praha 8, Czech Republic, 180 00 | |
| Pfizer Investigational Site | |
| Rychnov nad Kneznou, Czech Republic, 51601 | |
| Pfizer Investigational Site | |
| Strakonice, Czech Republic, 386 01 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00930059 History of Changes |
| Other Study ID Numbers: | B0401005 |
| Study First Received: | June 29, 2009 |
| Last Updated: | April 9, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Alzheimer's disease PF-04447943 efficacy safety plasma concentrations |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013