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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:
ClinicalTrials.gov Identifier:
NCT00455000
First Posted: April 2, 2007
Last Update Posted: October 14, 2009
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.
Information provided by:
Pfizer
March 29, 2007
April 2, 2007
October 14, 2009
March 2007
September 2009   (Final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00455000 on ClinicalTrials.gov Archive Site
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing. [ Time Frame: 366 days ]
To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing.
Not Provided
Not Provided
 
A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Biological: PF-04360365
    Monoclonal antibody
  • Drug: Placebo
    Placebo
  • Experimental: Active treatment
    5 possible active doses
    Intervention: Biological: PF-04360365
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided
 
Completed
37
September 2009
September 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Canada,   Sweden,   United Kingdom
Belgium
 
NCT00455000
A9951001
Yes
Not Provided
Not Provided
Director, Clinical Trials Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2009