Trial record 4 of 8 for:    PF-04360365

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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00607308
First received: January 22, 2008
Last updated: December 6, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Biological: PF-04360365
Drug: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: February 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.1 mg/kg Biological: PF-04360365
Single dose of 0.1 mg/kg IV on Day 1
Experimental: 0.5 mg/kg Biological: PF-04360365
Single dose of 0.5 mg/kg IV on Day 1
Experimental: 1 mg/kg Biological: PF-04360365
Single dose of 1 mg/kg IV on Day 1
Experimental: 5 mg/kg Biological: PF-04360365
Single dose of 5 mg/kg IV on Day 1
Placebo Comparator: Placebo Drug: Placebo
Single dose of placebo IV on Day 1
Experimental: 10 mg/kg Biological: PF-04360365
Single dose of 10 mg/kg IV on Day 1

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00607308

Locations
Japan
Pfizer Investigational Site
Hirosaki, Aomori, Japan
Pfizer Investigational Site
Fukuoka-shi, Fukuoka, Japan
Pfizer Investigational Site
Fukuyama city, Hiroshima, Japan
Pfizer Investigational Site
Tsukuba, Ibaraki, Japan
Pfizer Investigational Site
Niigata-shi, Niigata, Japan
Pfizer Investigational Site
Bunkyo-ku, Tokyo, Japan
Pfizer Investigational Site
Kodaira, Tokyo, Japan
Pfizer Investigational Site
Kanazawa, Japan
Pfizer Investigational Site
Kyoto, Japan
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00607308     History of Changes
Other Study ID Numbers: A9951005
Study First Received: January 22, 2008
Last Updated: December 6, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014