A Phase I, Single Dose Study Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

Phase 1

Completed

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

• Registration Number: NCT00607308
• Lead Sponsor: Pfizer

Brief Summary

The purpose of this study is to examine the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of PF-04360365 in Japanese subjects with mild to moderate Alzheimer's Disease.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-22
• Study First Submitted QC: 2008-01-22
• Study Start: 2008-02
• Study First Posted: 2008-02-05
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-06
• Last Update Posted: 2010-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Japanese male or females of non-childbearing potential, ages 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) 2) Text Revision of The Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR)
• Mini-Mental Status Exam score of 16-26 inclusive
• Rosen-Modified Hachinski Ischemia score < or = 4

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
0.5 mg/kg	PF-04360365	-
10 mg/kg	PF-04360365	-
0.1 mg/kg	PF-04360365	-
5 mg/kg	PF-04360365	-
1 mg/kg	PF-04360365	-

Primary Outcome Measures

Name	Time	Method
To examine the safety and tolerability of a single dose of PF-04360365 in Japanese subjects with mild to moderate AD for one year following dosing.	1 year

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.	1 year

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇯🇵 Kyoto, Japan