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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00930059

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	150
Study Start Date:	September 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PF-04447943: Experimental	Drug: PF-04447943 tablets, 25 mg every 12 hours for 12 wks
Placebo: Placebo Comparator	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

Contacts

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Locations

United States, California
Pfizer Investigational Site	Recruiting
San Diego, California, United States, 92103
Pfizer Investigational Site	Recruiting
Vista, California, United States, 92081
Pfizer Investigational Site	Not yet recruiting
Costa Mesa, California, United States, 92626
Pfizer Investigational Site	Not yet recruiting
Newport Beach, California, United States, 92663
Pfizer Investigational Site	Recruiting
Rancho Mirage, California, United States, 92270
United States, Florida
Pfizer Investigational Site	Recruiting
Plantation, Florida, United States, 33317
Pfizer Investigational Site	Recruiting
Hallandale Beach, Florida, United States, 33009
United States, Indiana
Pfizer Investigational Site	Not yet recruiting
Fort Wayne, Indiana, United States, 46805
United States, Kentucky
Pfizer Investigational Site	Recruiting
Paducah, Kentucky, United States, 42003
United States, Louisiana
Pfizer Investigational Site	Not yet recruiting
Lake Charles, Louisiana, United States, 70601
United States, Massachusetts
Pfizer Investigational Site	Not yet recruiting
Newton, Massachusetts, United States, 02459
United States, New York
Pfizer Investigational Site	Not yet recruiting
Cedarhurst, New York, United States, 11516
Canada, British Columbia
Pfizer Investigational Site	Recruiting
Kelowna, British Columbia, Canada, V1Y 3G8
Canada, Ontario
Pfizer Investigational Site	Not yet recruiting
Peterborough, Ontario, Canada, K9H 2P4
Canada, Quebec
Pfizer Investigational Site	Not yet recruiting
Sherbrooke, Quebec, Canada, J1H 1Z1

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0401005
Study First Received:	June 29, 2009
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00930059 History of Changes
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:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Central Nervous System Diseases
Alzheimer Disease

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 20, 2009