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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00733642
First received: August 11, 2008
Last updated: July 24, 2009
Last verified: July 2009
  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: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]
  • To evaluate the relationship of PF-04360365 plasma exposure and Aβ plasma exposure. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00733642     History of Changes
Other Study ID Numbers: A9951008
Study First Received: August 11, 2008
Last Updated: July 24, 2009
Health Authority: United States: Food and Drug Administration

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014