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Effect of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01005862
First received: October 30, 2009
Last updated: September 25, 2012
Last verified: September 2012
  Purpose

The primary goal of this study is to evaluate the effect of PF-04360365 on the clearance of ABETA from the CSF (cerebrospinal fluid) in patients with mild Alzheimer's disease and healthy volunteers. Additionally, the study will assess the pharmacokinetics of PF-04360365, pharmacokinetic and pharmacodynamic relationships in plasma and CSF and the safety and tolerability of single doses of PF-04360365 administered to patients with Alzheimer's disease and healthy volunteers.


Condition Intervention Phase
Alzheimer's Disease
Biological: PF-04360365
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Investigator And Subject-Blind, Sponsor-Open, Placebo-Controlled Study To Examine The Effects Of PF-04360365 On ABETA In Patients With Alzheimer's Disease And Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Fractional Clearance rate of ABeta peptide in CSF [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Area under the ratio of CSF labeled/unlabeled ABETA time curve from onset of clearance to 36h following start of infusion [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • PF-04360365 concentrations and ABETA concentrations in plasma and CSF [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration [ Time Frame: 36 hours ] [ Designated as safety issue: No ]
  • Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: March 2010
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-04360365 Biological: PF-04360365
10 mg/kg, single dose administered intravenously
Placebo Comparator: Placebo
single dose administered intravenously
Drug: Placebo
Placebo

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Males or females of non-childbearing potential (age 50 and over for Alzheimer's disease patients; 21-45 for healthy volunteers)
  • For patients with Alzheimer's Disease: Diagnosis of probable Alzheimer's disease, consistent with criteria from both National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and Diagnostic and Statistical Manual of Mental Disorders (DSM IV)
  • Mini-mental status exam score greater than or equal to 20
  • Rosen-Modified Hachinski Ischemia Score of < or = 4
  • On stable dose of background cholinesterase inhibitor or memantine at least 3 months prior to enrollment

Exclusion Criteria:

  • Diagnosis or history of other demential 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005862

Locations
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
Sweden
Pfizer Investigational Site
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01005862     History of Changes
Other Study ID Numbers: A9951011
Study First Received: October 30, 2009
Last Updated: September 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Alzheimer's disease antibody leucine ABeta

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2014