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

Tracking Information

First Received Date ^ICMJE

November 29, 2007

Last Updated Date

November 17, 2009

Start Date ^ICMJE

December 2007

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00566397 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: PF-04494700
Drug: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

400

Estimated Completion Date

March 2011

Estimated Primary Completion Date

November 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center	1-800-718-1021
Contact: Alzheimer's Disease Education and Referral Center (ADEAR)	1-800-438-4380

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00566397

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study ID Numbers ^ICMJE

B0341002

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Alzheimer's Disease Cooperative Study (ADCS)

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2009

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