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

NCT ID: NCT00930059

Last Updated: 2020-11-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-10

Study Completion Date

2010-09-22

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's disease PF-04447943 efficacy safety plasma concentrations

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PF-04447943

Group Type EXPERIMENTAL

PF-04447943

Intervention Type DRUG

tablets, 25 mg every 12 hours for 12 wks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

matching placebo tablets, every 12 hours for 12 wks

Interventions

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PF-04447943

tablets, 25 mg every 12 hours for 12 wks

Intervention Type DRUG

Placebo

matching placebo tablets, every 12 hours for 12 wks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Neurology Clinic, PC

Northport, Alabama, United States

Site Status

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Site Status

Southwestern Research Incorporated

Glendale, California, United States

Site Status

Pacific Coast Imaging (for Imaging only)

Newport Beach, California, United States

Site Status

The Southwest Institute for Clinical Research, Inc.

Rancho Mirage, California, United States

Site Status

Pacific Research Network (Satellite Site)

San Diego, California, United States

Site Status

Pacific Research Network, Inc. (Satellite Site)

Vista, California, United States

Site Status

MD Clinical

Hallandale, Florida, United States

Site Status

Compass Research, LLC

Orlando, Florida, United States

Site Status

Berma Research Group

Plantation, Florida, United States

Site Status

Joliet Center for Clinical Research

Joliet, Illinois, United States

Site Status

Fort Wayne Neurological Center

Fort Wayne, Indiana, United States

Site Status

Agewell

Indianapolis, Indiana, United States

Site Status

Four Rivers Clinical Research, Inc.

Paducah, Kentucky, United States

Site Status

Advanced MRI

Lake Charles, Louisiana, United States

Site Status

Lake Charles Clinical Trials, LLC

Lake Charles, Louisiana, United States

Site Status

Neurocare, Inc.

Newton, Massachusetts, United States

Site Status

Neurobehavioral Research Inc

Cedarhurst, New York, United States

Site Status

Behavioral Medical Research of Staten Island

Staten Island, New York, United States

Site Status

University of Pittsburgh Alzheimer's Disease Research Center

Pittsburgh, Pennsylvania, United States

Site Status

Rhode Island Hospital, Alzheimer's Disease and Memory Disorders Center

Providence, Rhode Island, United States

Site Status

Neurology Clinic, PC

Cordova, Tennessee, United States

Site Status

Medical Arts Health Research Group

Kelowna, British Columbia, Canada

Site Status

Hamilton Health Sciences

Hamilton, Ontario, Canada

Site Status

Kawartha Regional Memory Clinic

Peterborough, Ontario, Canada

Site Status

Neuro Rive Sud Clinic

Greenfield Park, Quebec, Canada

Site Status

Diex Recherche Inc.

Sherbrooke, Quebec, Canada

Site Status

Psicomed Estudios Clinicos

Antofagasta, Antofagasta, Chile

Site Status

Hospital Base Valdivia

Valdivia, Los Ríos Region, Chile

Site Status

Centro Doctora Lissette Duque

Providencia, RM, Chile

Site Status

Psicomedica Research Group

Santiago, RM, Chile

Site Status

Hospital Del Salvador

Santiago, RM, Chile

Site Status

Neuroconsult

Santiago, RM, Chile

Site Status

Especialidades Medicas L y S

Santiago, RM, Chile

Site Status

Neuropsicologia Ltda.

La Florida, Santiago Metropolitan, Chile

Site Status

Fakultni nemocnice

Hradec Králové, , Czechia

Site Status

Pardubicka krajska nemocnice, a.s.

Pardubice, , Czechia

Site Status

Pragtis, s.r.o.

Prague, , Czechia

Site Status

Fakultni nemocnice v Motole

Prague, , Czechia

Site Status

Psychiatry Trial, s.r.o.

Prague, , Czechia

Site Status

Psychiatricka ambulance

Prague, , Czechia

Site Status

Neurologie - EEG, s.r.o

Prague, , Czechia

Site Status

Centrum neurologicke pece, s.r.o.

Rychnov nad Kněžnou, , Czechia

Site Status

Psychiatricka ambulance

Strakonice, , Czechia

Site Status

Countries

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United States Canada Chile Czechia

Related Links

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Other Identifiers

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2009-012179-82

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B0401005

Identifier Type: -

Identifier Source: org_study_id