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

November 28, 2018 updated by: Pfizer

A Double Blind, Placebo Controlled, Randomized, Multicenter Study Evaluating The Efficacy And Safety Of Eighteen Months Of Treatment With PF 04494700 (TTP488) In Participants With Mild To Moderate Alzheimer's Disease

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

402

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pfizer Investigational Site
      • Sun City, Arizona, United States, 85351
        • Pfizer Investigational Site
    • California
      • Irvine, California, United States, 92697-1385
        • Pfizer Investigational Site
      • Irvine, California, United States, 92697-3959
        • Pfizer Investigational Site
      • Irvine, California, United States, 92697-4285
        • Pfizer Investigational Site
      • Irvine, California, United States, 92697
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90095
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • Martinez, California, United States, 94553
        • Pfizer Investigational Site
      • Newport Beach, California, United States, 92660
        • Pfizer Investigational Site
      • Orange, California, United States, 92868
        • Pfizer Investigational Site
      • Palo Alto, California, United States, 94304
        • Pfizer Investigational Site
      • Sacramento, California, United States, 95817
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103
        • Pfizer Investigational Site
      • San Diego, California, United States, 92128
        • Pfizer Investigational Site
      • San Diego, California, United States, 92103-8749
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94143
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94121
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94117
        • Pfizer Investigational Site
      • Vista, California, United States, 92081
        • Pfizer Investigational Site
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06510
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06509
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Pfizer Investigational Site
      • Washington, District of Columbia, United States, 20007
        • Pfizer Investigational Site
      • Washington, District of Columbia, United States, 20057
        • Pfizer Investigational Site
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Pfizer Investigational Site
      • Miami Beach, Florida, United States, 33140
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33613
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30329-5102
        • Pfizer Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Pfizer Investigational Site
      • Chicago, Illinois, United States, 60612
        • Pfizer Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, United States, 40504
        • Pfizer Investigational Site
      • Lexington, Kentucky, United States, 40536
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Pfizer Investigational Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Pfizer Investigational Site
      • Grand Rapids, Michigan, United States, 49503
        • Pfizer Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89106
        • Pfizer Investigational Site
    • New York
      • New York, New York, United States, 10029
        • Pfizer Investigational Site
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
      • New York, New York, United States, 10016
        • Pfizer Investigational Site
      • Rochester, New York, United States, 14620
        • Pfizer Investigational Site
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97201
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15213
        • Pfizer Investigational Site
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Pfizer Investigational Site
      • North Charleston, South Carolina, United States, 29406-6076
        • Pfizer Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37208
        • Pfizer Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77098
        • Pfizer Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Pfizer Investigational Site
    • Washington
      • Seattle, Washington, United States, 98108
        • Pfizer Investigational Site
      • Seattle, Washington, United States, 98104
        • Pfizer Investigational Site
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Pfizer Investigational Site
      • Madison, Wisconsin, United States, 53792
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
Drug: PF-04494700
15 mg for 6 days followed by daily dosing of 5mg
Drug: PF-04494700
60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.
EXPERIMENTAL: 2
Drug: PF-04494700
15 mg for 6 days followed by daily dosing of 5mg
Drug: PF-04494700
60 mg for 6 days followed by daily dosing of 20mg. Dosing in this arm has been discontinued.
PLACEBO_COMPARATOR: 3
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment.
Time Frame: 18 Month
18 Month
Examine the safety and tolerability of PF 04494700 relative to placebo. Adverse events, vital signs, physical exam, neuro exam, 12-lead ECG, lab tests (hematology, blood chemistry, urinalysis) and brain magnetic resonance imaging (MRI).
Time Frame: 18 Month
18 Month

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET)
Time Frame: 18 Month
18 Month
Evaluate the potential dose response of PF 04494700
Time Frame: 18 Month
18 Month
Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints
Time Frame: 18 Month
18 Month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Alzheimer's Disease Cooperative Study (ADCS)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2007

Primary Completion (ACTUAL)

December 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

November 29, 2007

First Submitted That Met QC Criteria

November 29, 2007

First Posted (ESTIMATE)

December 3, 2007

Study Record Updates

Last Update Posted (ACTUAL)

November 30, 2018

Last Update Submitted That Met QC Criteria

November 28, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0341002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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