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

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

Show 43 Study Locations

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:	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 16, 2013