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

Sponsor:	Pfizer
Collaborator:	Alzheimer's Disease Cooperative Study (ADCS)
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00566397

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 II

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

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

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

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

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:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00566397 History of Changes
Other Study ID Numbers:	B0341002
Study First Received:	November 29, 2007
Last Updated:	May 31, 2011
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 February 09, 2012