A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Biological: PF-04360365; Drug: Placebo

• Registration Number: NCT00455000
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and well tolerated in Adults with Mild to Moderate Alzheimer's disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-03-29
• Study First Submitted QC: 2007-03-30
• Study First Posted: 2007-04-02
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-12
• Last Update Posted: 2009-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

• Male or Females of non-childbearing potential, age 50-85
• Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); and 2)Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
• Mini-mental status exam score of 16-26 inclusive
• Rosen-Modified Hachinski Ischemia Score < or = 4

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Exclusion Criteria

• Diagnosis or history of other dementia or neurodegenerative disorders
• Diagnosis or history of clinically significant cerebrovascular disease
• Specific findings on magnetic resonance imaging (MRI): cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities
• History of autoimmune disorders
• History of allergic or anaphylactic reactions

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active treatment	PF-04360365	5 possible active doses
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
To examine the safety, tolerability, and pharmacokinetics of a single dose of PF-04360365 in subjects with mild to moderate AD for one year following dosing.	366 days

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.	366 days

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Southampton, United Kingdom