A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease

NCT ID: NCT00566397

Last Updated: 2018-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

402 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of PF 04494700 in participants with mild to moderate Alzheimer's disease.

Detailed Description

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Conditions

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Alzheimer's Disease

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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1

Group Type EXPERIMENTAL

PF-04494700

Intervention Type DRUG

15 mg for 6 days followed by daily dosing of 5mg

2

Group Type EXPERIMENTAL

PF-04494700

Intervention Type DRUG

60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.

3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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PF-04494700

15 mg for 6 days followed by daily dosing of 5mg

Intervention Type DRUG

PF-04494700

60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Mini Mental State Exam (MMSE) score between 14-26 (inclusive) at screening.
* Participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization

Exclusion Criteria

* Current evidence or history of neurological, psychiatric and any other illness that could contribute to non-Alzheimer's dementia.
* Known history of familial AD or any evidence for early onset AD known or possibly associated with genetic mutations.
* Evidence or history of diabetes mellitus Type 1 or Type 2.
* History or symptoms of autoimmune disorders.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alzheimer's Disease Cooperative Study (ADCS)

OTHER

Sponsor Role collaborator

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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Pfizer Investigational Site

Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Irvine, California, United States

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Irvine, California, United States

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Irvine, California, United States

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Irvine, California, United States

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La Jolla, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Martinez, California, United States

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Newport Beach, California, United States

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Orange, California, United States

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Palo Alto, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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San Francisco, California, United States

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Vista, California, United States

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New Haven, Connecticut, United States

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New Haven, Connecticut, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Jacksonville, Florida, United States

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Miami Beach, Florida, United States

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Tampa, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Grand Rapids, Michigan, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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New York, New York, United States

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New York, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Beachwood, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Charleston, South Carolina, United States

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North Charleston, South Carolina, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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Seattle, Washington, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Madison, Wisconsin, United States

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Countries

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United States

Other Identifiers

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B0341002

Identifier Type: -

Identifier Source: org_study_id

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