COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

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. Identifier: NCT01005862
Recruitment Status : Completed
First Posted : November 1, 2009
Last Update Posted : September 26, 2012
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Alzheimer's Disease Biological: PF-04360365 Drug: Placebo Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
Study Start Date : March 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: PF-04360365 Biological: PF-04360365
10 mg/kg, single dose administered intravenously

Placebo Comparator: Placebo
single dose administered intravenously
Drug: Placebo

Primary Outcome Measures :
  1. Fractional Clearance rate of ABeta peptide in CSF [ Time Frame: 36 hours ]

Secondary Outcome Measures :
  1. 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 ]
  2. PF-04360365 concentrations and ABETA concentrations in plasma and CSF [ Time Frame: 36 hours ]
  3. Ratio of labeled/unlabeled leucine in plasma and CSF post labeled leucine administration [ Time Frame: 36 hours ]
  4. Adverse events, vital signs, clinical labs, electrocardiograms, physical / neurologic examinations, Columbia Suicide Severity Rating Scale, MRI [ Time Frame: 6 months ]

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.

Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT01005862

Layout table for location information
United States, California
Pfizer Investigational Site
Glendale, California, United States, 91206
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63110
Pfizer Investigational Site
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Layout table for investigator information
Study Director: Pfizer Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer Identifier: NCT01005862    
Other Study ID Numbers: A9951011
First Posted: November 1, 2009    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012
Keywords provided by Pfizer:
Alzheimer's disease antibody leucine ABeta
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders