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

Sponsors

Lead Sponsor: Pfizer

Source Pfizer
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.

Overall Status Completed
Start Date September 2009
Completion Date September 2010
Primary Completion Date September 2010
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Change from baseline on Alzheimer's Disease Assessment Scale (Cognitive Subscale) screen, baseline, wks 3, 6, 9, 12
Secondary Outcome
Measure Time Frame
Change from baseline on Neuropsychiatric Inventory screen, baseline, wks 3, 6, 9, 12
Clinical Global Impression - Improvement wks 3, 6, 9, 12
Safety Assessments (including adverse events, vital signs, electrocardiograms, laboratory tests) screen, baseline, weeks 1, 3, 6, 9, 12
Plasma Concentrations of PF-04447943 wks 1, 3, 6, 9, 12
Enrollment 198
Condition
Intervention

Intervention Type: Drug

Intervention Name: PF-04447943

Description: tablets, 25 mg every 12 hours for 12 wks

Arm Group Label: PF-04447943

Intervention Type: Drug

Intervention Name: Placebo

Description: matching placebo tablets, every 12 hours for 12 wks

Arm Group Label: Placebo

Eligibility

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

Gender: All

Minimum Age: 55 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Pfizer CT.gov Call Center Study Director Pfizer
Location
Facility:
Pfizer Investigational Site | Northport, Alabama, 35476, United States
Pfizer Investigational Site | Costa Mesa, California, 92626, United States
Pfizer Investigational Site | Glendale, California, 91204, United States
Pfizer Investigational Site | Newport Beach, California, 92663, United States
Pfizer Investigational Site | Rancho Mirage, California, 92270, United States
Pfizer Investigational Site | San Diego, California, 92128, United States
Pfizer Investigational Site | Vista, California, 92081, United States
Pfizer Investigational Site | Hallandale Beach, Florida, 33009, United States
Pfizer Investigational Site | Orlando, Florida, 32806, United States
Pfizer Investigational Site | Plantation, Florida, 33317, United States
Pfizer Investigational Site | Joliet, Illinois, 60435, United States
Pfizer Investigational Site | Fort Wayne, Indiana, 46805, United States
Pfizer Investigational Site | Indianapolis, Indiana, 46260, United States
Pfizer Investigational Site | Paducah, Kentucky, 42003, United States
Pfizer Investigational Site | Lake Charles, Louisiana, 70601, United States
Pfizer Investigational Site | Newton, Massachusetts, 02459, United States
Pfizer Investigational Site | Cedarhurst, New York, 11516, United States
Pfizer Investigational Site | Staten Island, New York, 10305, United States
Pfizer Investigational Site | Pittsburgh, Pennsylvania, 15213, United States
Pfizer Investigational Site | Providence, Rhode Island, 02903, United States
Pfizer Investigational Site | Cordova, Tennessee, 38018, United States
Pfizer Investigational Site | Kelowna, British Columbia, V1Y 3G8, Canada
Pfizer Investigational Site | Hamilton, Ontario, L9C 7N4, Canada
Pfizer Investigational Site | Peterborough, Ontario, K9H 2P4, Canada
Pfizer Investigational Site | Greenfield Park, Quebec, J4V 2J2, Canada
Pfizer Investigational Site | Sherbrooke, Quebec, J1H 1Z1, Canada
Pfizer Investigational Site | Antofagasta, II Region, Chile
Pfizer Investigational Site | Providencia, RM, 7500617, Chile
Pfizer Investigational Site | Santiago, RM, 7500710, Chile
Pfizer Investigational Site | Santiago, RM, 7500922, Chile
Pfizer Investigational Site | Santiago, RM, 7550112, Chile
Pfizer Investigational Site | Santiago, RM, 7560356, Chile
Pfizer Investigational Site | La Florida, Santiago, 8260094, Chile
Pfizer Investigational Site | Valdivia, XIV Region, 5090145, Chile
Pfizer Investigational Site | Hradec Kralove, 500 05, Czech Republic
Pfizer Investigational Site | Pardubice, 53203, Czech Republic
Pfizer Investigational Site | Praha 2, 120 00, Czech Republic
Pfizer Investigational Site | Praha 5, 150 08, Czech Republic
Pfizer Investigational Site | Praha 5, 15800, Czech Republic
Pfizer Investigational Site | Praha 8, 180 00, Czech Republic
Pfizer Investigational Site | Praha 8, 18000, Czech Republic
Pfizer Investigational Site | Rychnov nad Kneznou, 51601, Czech Republic
Pfizer Investigational Site | Strakonice, 386 01, Czech Republic
Location Countries

Canada

Chile

Czech Republic

United States

Verification Date

April 2013

Responsible Party

Name Title: Director, Clinical Trial Disclosure Group

Organization: Pfizer, Inc.

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: PF-04447943

Type: Experimental

Label: Placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov