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

December 6, 2010 updated by: Pfizer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kanazawa, Japan
        • Pfizer Investigational Site
      • Kyoto, Japan
        • Pfizer Investigational Site
    • Aomori
      • Hirosaki, Aomori, Japan
        • Pfizer Investigational Site
    • Fukuoka
      • Fukuoka-shi, Fukuoka, Japan
        • Pfizer Investigational Site
    • Hiroshima
      • Fukuyama city, Hiroshima, Japan
        • Pfizer Investigational Site
    • Ibaraki
      • Tsukuba, Ibaraki, Japan
        • Pfizer Investigational Site
    • Niigata
      • Niigata-shi, Niigata, Japan
        • Pfizer Investigational Site
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Pfizer Investigational Site
      • Kodaira, Tokyo, Japan
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Single dose of placebo IV on Day 1
Experimental: 0.1 mg/kg
Biological: PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 1 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 5 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 10 mg/kg IV on Day 1
Experimental: 0.5 mg/kg
Biological: PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 1 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 5 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 10 mg/kg IV on Day 1
Experimental: 1 mg/kg
Biological: PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 1 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 5 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 10 mg/kg IV on Day 1
Experimental: 5 mg/kg
Biological: PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 1 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 5 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 10 mg/kg IV on Day 1
Experimental: 10 mg/kg
Biological: PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 1 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 5 mg/kg IV on Day 1
Biological: PF-04360365
Single dose of 10 mg/kg IV on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

January 22, 2008

First Submitted That Met QC Criteria

January 22, 2008

First Posted (Estimate)

February 5, 2008

Study Record Updates

Last Update Posted (Estimate)

December 7, 2010

Last Update Submitted That Met QC Criteria

December 6, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A9951005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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