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

  Show 62 Study Locations
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 July 22, 2014