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

November 29, 2007
March 19, 2013
December 2007
December 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Evaluate the efficacy of PF 04494700 relative to placebo [ Time Frame: 18 Month ]
  • Examine the safety and tolerability of PF 04494700 relative to placebo [ Time Frame: 18 Month ]
Complete list of historical versions of study NCT00566397 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition [ Time Frame: 18 Month ]
  • Evaluate the potential dose response of PF 04494700 [ Time Frame: 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 ]
Not Provided
Not Provided
 
A Phase 2 Study Evaluating The Efficacy And Safety Of PF 04494700 In Mild To Moderate Alzheimer's Disease
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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.
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Intervention: Drug: PF-04494700
  • Experimental: 2
    Intervention: Drug: PF-04494700
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
402
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00566397
B0341002
Yes
Pfizer
Pfizer
Alzheimer's Disease Cooperative Study (ADCS)
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP