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Single Dose Escalation Study of PF-04360365 In Subjects With Mild To Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00733642
First Posted: August 13, 2008
Last Update Posted: July 28, 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
  Purpose
The purpose of this study is to determine whether single doses of PF-04360365 is safe and well tolerated in patients with Alzheimer's Disease.

Condition Intervention Phase
Alzheimer's Disease Biological: PF-04360365 1 mg/kg Biological: PF-04360365 3 mg/kg Biological: PF-04360365 5 mg/kg Biological: PF-04360365 10 mg/kg Phase 1

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Single Dose Escalation Study Of PF-04360365 In Subjects 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 subjects with mild-to-moderate AD. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • To characterize the pharmacokinetic profile of PF-04360365 following administration of an IV infusion in subjects with mild-to-moderate AD. [ Time Frame: 6 months ]
  • To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure. [ Time Frame: 6 months ]

Enrollment: 15
Study Start Date: August 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04360365 1 mg/kg Biological: PF-04360365 1 mg/kg
PF-04360365 1 mg/kg infused as a single dose
Experimental: PF-04360365 3 mg/kg Biological: PF-04360365 3 mg/kg
PF-04360365 3 mg/kg infused as a single dose
Experimental: PF-04360365 5 mg/kg Biological: PF-04360365 5 mg/kg
PF-04360365 5 mg/kg infused as a single dose
Experimental: PF-04360365 10 mg/kg Biological: PF-04360365 10 mg/kg
PF-04360365 10 mg/kg infused as a single dose

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female (of non-child bearing potential) subjects ages ≥50 years of age.
  • Diagnosis of probable AD (of mild to moderate severity), consistent with criteria from both: NINCDS-Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR.
  • MMSE score of 16-26 inclusive.
  • Rosen-Modified Hachinski Ischemia Score ≤4.
  • On a stable dose of background cholinesterase inhibitors or memantine for at least 60 days prior to dosing.

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.
  • History of allergic or anaphylactic reactions.
  Contacts and Locations
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): NCT00733642


Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
United States, New Jersey
Pfizer Investigational Site
Eatontown, New Jersey, United States, 07724
Pfizer Investigational Site
Oakhurst, New Jersey, United States, 07755
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00733642     History of Changes
Other Study ID Numbers: A9951008
First Submitted: August 11, 2008
First Posted: August 13, 2008
Last Update Posted: July 28, 2009
Last Verified: July 2009

Keywords provided by Pfizer:
antibody amyloid Alzheimer's Disease AD

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders