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

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: PF-04494700

• Registration Number: NCT00566397
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2007-11-29
• Study First Submitted QC: 2007-11-29
• Study Start: 2007-12
• Study First Posted: 2007-12-03
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Disposition First Submitted: 2013-03-19
• Disposition First Submitted QC: 2013-03-19
• Disposition First Posted: 2013-03-25
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-28
• Last Update Posted: 2018-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Placebo	-
2	PF-04494700	-
1	PF-04494700	-

Primary Outcome Measures

Name	Time	Method
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).	18 Month
Evaluate the efficacy of PF 04494700 relative to placebo. Change from baseline in a standardized cognitive measure after 18 months of treatment.	18 Month

Secondary Outcome Measures

Name	Time	Method
Evaluate the pharmacokinetics and characterize the pharmacokinetic (PK)/ pharmacodynamic (PD) relationship of PF 04494700 to potential biomarkers and relevant efficacy and safety endpoints	18 Month
Evaluate the effects of PF 04494700 on potential biomarkers of RAGE inhibition and amyloid imaging (AV-45, F18 PET)	18 Month
Evaluate the potential dose response of PF 04494700	18 Month

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Madison, Wisconsin, United States