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A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00455000
First received: March 29, 2007
Last updated: October 12, 2009
Last verified: October 2009
History of Changes
  Purpose

The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and well tolerated in Adults 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 I, Randomized, Placebo Controlled, Double Blind Dose Escalation Study Of The Safety, Tolerability, Pharmacokinetics,Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To examine the safety, tolerability, and pharmacokinetics of a single dose of PF-04360365 in subjects with mild to moderate AD for one year following dosing. [ Time Frame: 366 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing. [ Time Frame: 366 days ] [ Designated as safety issue: No ]

Enrollment: 37
Study Start Date: March 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active treatment
5 possible active doses
 Biological: PF-04360365
Monoclonal antibody
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

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

Inclusion Criteria:

  • Male or Females of non-childbearing potential, age 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); and 2)Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
  • 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: NCT00455000

Locations
Australia, Victoria
Pfizer Investigational Site
Heidelberg West, Victoria, Australia, 3081
Australia, Western Australia
Pfizer Investigational Site
Fremantle, Western Australia, Australia, 6160
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Canada, Ontario
Pfizer Investigational Site
London, Ontario, Canada, N6A 4G5
Pfizer Investigational Site
London, Ontario, Canada, N6C 5J1
Pfizer Investigational Site
Toronto, Ontario, Canada, M3B 2W7
Pfizer Investigational Site
Toronto, Ontario, Canada, M5V 2T3
Pfizer Investigational Site
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Pfizer Investigational Site
Montreal, Quebec, Canada, H1T 2M4
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 141 86
United Kingdom
Pfizer Investigational Site
Southampton, United Kingdom, SO16 6YD
Pfizer Investigational Site
Southampton, United Kingdom, SO30 3JB
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Director, Clinical Trials Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00455000     History of Changes
Other Study ID Numbers: A9951001
Study First Received: March 29, 2007
Last Updated: October 12, 2009
Health Authority: Canada: Health Canada

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 May 19, 2013