Trial record 1 of 2 for:    Alzheimer's disease AND RAGE
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A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Collaborator:
Alzheimer's Disease Cooperative Study (ADCS)
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00566397
First received: November 29, 2007
Last updated: March 19, 2013
Last verified: March 2013
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: PF-04494700
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 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET) [ Time Frame: 18 Month ] [ Designated as safety issue: No ]
  • Evaluate the potential dose response of PF 04494700 [ Time Frame: 18 Month ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 402
Study Start Date: December 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: PF-04494700
15 mg for 6 days followed by daily dosing of 5mg
Experimental: 2 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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00566397

  Hide Study Locations
Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85006
Pfizer Investigational Site
Sun City, Arizona, United States, 85351
United States, California
Pfizer Investigational Site
Irvine, California, United States, 92697
Pfizer Investigational Site
Irvine, California, United States, 92697-4285
Pfizer Investigational Site
Irvine, California, United States, 92697-1385
Pfizer Investigational Site
Irvine, California, United States, 92697-3959
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, 92103-8749
Pfizer Investigational Site
San Diego, California, United States, 92128
Pfizer Investigational Site
San Diego, California, United States, 92103
Pfizer Investigational Site
San Francisco, California, United States, 94121
Pfizer Investigational Site
San Francisco, California, United States, 94117
Pfizer Investigational Site
San Francisco, California, United States, 94143
Pfizer Investigational Site
Vista, California, United States, 92081
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Pfizer Investigational Site
New Haven, Connecticut, United States, 06509
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
United States, District of Columbia
Pfizer Investigational Site
Washington, District of Columbia, United States, 20057
Pfizer Investigational Site
Washington, District of Columbia, United States, 20060
Pfizer Investigational Site
Washington, District of Columbia, United States, 20007
United States, Florida
Pfizer Investigational Site
Jacksonville, Florida, United States, 32224
Pfizer Investigational Site
Miami Beach, Florida, United States, 33140
Pfizer Investigational Site
Tampa, Florida, United States, 33613
United States, Georgia
Pfizer Investigational Site
Atlanat, Georgia, United States, 30329-5102
United States, Illinois
Pfizer Investigational Site
Chicago, Illinois, United States, 60612
Pfizer Investigational Site
Chicago, Illinois, United States, 60611
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46202
United States, Kentucky
Pfizer Investigational Site
Lexington, Kentucky, United States, 40536
Pfizer Investigational Site
Lexington, Kentucky, United States, 40504
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21224
United States, Massachusetts
Pfizer Investigational Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Pfizer Investigational Site
Ann Arbor, Michigan, United States, 48109
Pfizer Investigational Site
Grand Rapids, Michigan, United States, 49503
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63108
United States, Nevada
Pfizer Investigational Site
Las Vegas, Nevada, United States, 89106
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10032
Pfizer Investigational Site
New York, New York, United States, 10016
Pfizer Investigational Site
New York, New York, United States, 10029
Pfizer Investigational Site
Rochester, New York, United States, 14620
United States, Ohio
Pfizer Investigational Site
Beachwood, Ohio, United States, 44122
United States, Oregon
Pfizer Investigational Site
Portland, Oregon, United States, 97201
United States, Pennsylvania
Pfizer Investigational Site
Philadelphia, Pennsylvania, United States, 19104
Pfizer Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Pfizer Investigational Site
Providence, Rhode Island, United States, 02903
United States, South Carolina
Pfizer Investigational Site
Charleston, South Carolina, United States, 29425
Pfizer Investigational Site
North Charleston, South Carolina, United States, 29406-6076
United States, Tennessee
Pfizer Investigational Site
Nashville, Tennessee, United States, 37208
United States, Texas
Pfizer Investigational Site
Dallas, Texas, United States, 75390
Pfizer Investigational Site
Houston, Texas, United States, 77098
Pfizer Investigational Site
Houston, Texas, United States, 77030
United States, Utah
Pfizer Investigational Site
Salt Lake City, Utah, United States, 84108
United States, Washington
Pfizer Investigational Site
Seattle, Washington, United States, 98108
Pfizer Investigational Site
Seattle, Washington, United States, 98104
United States, Wisconsin
Pfizer Investigational Site
Madison, Wisconsin, United States, 53705
Pfizer Investigational Site
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Pfizer
Alzheimer's Disease Cooperative Study (ADCS)
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00566397     History of Changes
Other Study ID Numbers: B0341002
Study First Received: November 29, 2007
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
RI RI Study Rage Inhibitors

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 August 01, 2014