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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607308
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : December 7, 2010
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Biological: PF-04360365 Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : February 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

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

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607308


Locations
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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
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00607308    
Other Study ID Numbers: A9951005
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: December 7, 2010
Last Verified: December 2010
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders