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A Study Of PF-04447943 Compared To Placebo In Subjects With Mild To Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00930059
Recruitment Status : Completed
First Posted : June 30, 2009
Last Update Posted : April 16, 2013
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: PF-04447943 Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline on Alzheimer's Disease Assessment Scale (Cognitive Subscale) [ Time Frame: screen, baseline, wks 3, 6, 9, 12 ]

Secondary Outcome Measures :
  1. Change from baseline on Neuropsychiatric Inventory [ Time Frame: screen, baseline, wks 3, 6, 9, 12 ]
  2. Clinical Global Impression - Improvement [ Time Frame: wks 3, 6, 9, 12 ]
  3. Safety Assessments (including adverse events, vital signs, electrocardiograms, laboratory tests) [ Time Frame: screen, baseline, weeks 1, 3, 6, 9, 12 ]
  4. Plasma Concentrations of PF-04447943 [ Time Frame: wks 1, 3, 6, 9, 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
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, 7500922
Pfizer Investigational Site
Santiago, RM, Chile, 7550112
Pfizer Investigational Site
Santiago, RM, Chile, 7560356
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, 150 08
Pfizer Investigational Site
Praha 5, Czech Republic, 15800
Pfizer Investigational Site
Praha 8, Czech Republic, 180 00
Pfizer Investigational Site
Praha 8, Czech Republic, 18000
Pfizer Investigational Site
Rychnov nad Kneznou, Czech Republic, 51601
Pfizer Investigational Site
Strakonice, Czech Republic, 386 01
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00930059    
Other Study ID Numbers: B0401005
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: April 16, 2013
Last Verified: April 2013
Keywords provided by Pfizer:
Alzheimer's disease
plasma concentrations
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders