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

Alzheimer's Disease Clinical Trial

Official title:

A Phase 1, Randomized, Placebo-Controlled, Double Blind, Dose-Escalation, Multicenter Study Of The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Japanese Patients With Mild To Moderate Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00607308
• Other study ID #: A9951005
• Status: Completed
• Phase: Phase 1
• First received: January 22, 2008
• Last updated: December 6, 2010
• Start date: February 2008
• Est. completion date: October 2010

Study information

• Verified date: December 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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

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

Study Design

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Biological:
• PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
• PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
• PF-04360365
Single dose of 1 mg/kg IV on Day 1
• PF-04360365
Single dose of 5 mg/kg IV on Day 1

Drug:
• Placebo
Single dose of placebo IV on Day 1

Biological:
• PF-04360365
Single dose of 10 mg/kg IV on Day 1

Locations

Country	Name	City	State
Japan	Pfizer Investigational Site	Bunkyo-ku	Tokyo
Japan	Pfizer Investigational Site	Fukuoka-shi	Fukuoka
Japan	Pfizer Investigational Site	Fukuyama city	Hiroshima
Japan	Pfizer Investigational Site	Hirosaki	Aomori
Japan	Pfizer Investigational Site	Kanazawa
Japan	Pfizer Investigational Site	Kodaira	Tokyo
Japan	Pfizer Investigational Site	Kyoto
Japan	Pfizer Investigational Site	Niigata-shi	Niigata
Japan	Pfizer Investigational Site	Tsukuba	Ibaraki

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.		1 year	No

External Links

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