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

History of Changes

Tracking Information

First Received Date ^ICMJE

November 29, 2007

Last Updated Date

March 19, 2013

Start Date ^ICMJE

December 2007

Primary Completion Date

December 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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

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

Study Arm (s)

Experimental: 1
Intervention: Drug: PF-04494700
Experimental: 2
Intervention: Drug: PF-04494700
Placebo Comparator: 3
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

402

Completion Date

December 2010

Primary Completion Date

December 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 information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00566397

Other Study ID Numbers ^ICMJE

B0341002

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

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

March 2013

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

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