Measuring Brain Amyloid Plaque Load in Older Adults Using Bayer 94-9172 Positron Emission Tomography and X-ray Computed Tomography

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by New York State Psychiatric Institute
Sponsor:
Collaborators:
Bayer
Information provided by (Responsible Party):
Yaakov Stern, New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01222351
First received: October 14, 2010
Last updated: August 14, 2014
Last verified: August 2014
  Purpose

The overall goal of this project is to establish and validate biomarkers associated with the risk and progression of late onset Alzheimer's disease, mild cognitive impairment and cognitive decline. The investigators will use baseline and longitudinal measurements of plasma amyloid beta-40 and amyloid beta-42 to investigate the risk of developing mild cognitive impairment and late onset Alzheimer's disease, as well as the rates of cognitive decline and Alzheimer's disease progression. Participants will be selected on the basis of change in plasma amyloid beta levels over prior assessment intervals. The purpose of the study is to examine whether brain amyloid plaque load, which will be measured with positron emission tomography and x-ray computed tomography brain imaging using Florbetaben from Bayer, varies as a function of change in plasma levels of amyloid beta. The driving hypothesis of the study is that high plasma levels of amyloid beta are an antecedent indicator of increased risk of cognitive decline, mild cognitive impairment, and incident late onset Alzheimer's disease, and that declining plasma levels of amyloid beta are associated with the onset of cognitive decline. Further, high plasma levels of amyloid beta are related to increased levels of amyloid beta in the brain as measured by positron emission tomography positivity, and the specific pattern of positron emission tomography positivity and a decline in plasma amyloid beta over time are associated with the onset of cognitive decline associated with late onset Alzheimer's disease.


Condition Intervention
Late Onset Alzheimer Disease
Drug: BAY 94-9172 (Florbetaben)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: BAY 94-9172 PET/CT in Cognitively Normal Older Adults, Older Adults With Mild Cognitive Impairment, and Older Adults With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Changes in amyloid plaque load in the brain of the course of 3 years [ Time Frame: Amyloid plaque load in the brain will be measured at baseline and again 3 years later ] [ Designated as safety issue: No ]
    Positron emission tomography (PET) and x-ray computed tomography (CT) brain imaging using Florbetaben is considered an in vivo measure of brain amyloid plaque load. We will obtain PET/CT scans on a selection of participants who will be selected on the basis of change in plasma levels of amyloid beta to validate amyloid beta as a viable biomarker for late onset Alzheimer's disease. Participants will receive scans in a 2010-2012 assessment wave, and then again in a 2014-2015 assessment wave to determine whether increased uptake in the brain correlates with declining levels of plasma amyloid beta


Estimated Enrollment: 200
Study Start Date: December 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BAY 94-9172
BAY 94-9172 PET/CT
Drug: BAY 94-9172 (Florbetaben)
Measure of brain amyloid load using BAY 94-9172 PET/CT
Other Names:
  • Florbetaben
  • Bay 91-9172

Detailed Description:

This project is a sub-study of the Washington Heights-Inwood Community Aging Project, which is a multidisciplinary, epidemiological study of Alzheimer's disease and related neurodegenerative disorders. We will obtain positron emission tomography scans and simultaneous x-ray computed tomography scans using Florbetaben from Bayer on a selection of ongoing participants who will be selected on the basis of change in plasma levels of amyloid beta over time. Approximately 200 participants will receive scans beginning in 2009 and in the 2010-2012 assessment wave and then again in a 2014-2015 assessment wave. Our intention is to examine whether uptake of Florbetaben in the brain varies as a function of previous history of change in plasma levels of amyloid beta in order to validate plasma amyloid beta as a viable biomarker for late onset Alzheimer's disease.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Current Washington Heights-Inwood Community Aging Project (WHICAP) participant Age 65 or older Residing in the community of Washington-Heights/Inwood/Hamilton Heights
  • Is able to provide informed consent, understand the information provided on the purpose and conduct of the trial and exhibits adequate visual, auditory and communication capabilities to enable compliance with study procedures. This includes performing the psychometric testing and being able to lie down flat in the Positron Emission Tomography (PET) scanner
  • Possesses a general health that permits adequate compliance with all study procedures.
  • Informed consent has been signed and dated (with time) by the subject and/or the subject's caregiver (for probable Alzheimer's Disease (AD) patients)

Exclusion Criteria:

  • Has any contraindication to PET, such as claustrophobia, or inability to lie flat for half an hour as determined by the onsite radiologist performing the scan
  • Current, past, or anticipated exposure to radiation, which may include being badged for radiation exposure in the workplace or participation in nuclear medicine procedures, including research protocols in the last year
  • Significant active physical illness particularly those that may affect the brain including blood dyscrasias, lymphomas, hypersplenism, endocrinopathies, renal failure or chronic obstructive lung disease, autonomic neuropathies, peripheral vascular disease, low hemoglobin and malignancy
  • Scheduled for surgery and/or another invasive procedure within the time period of up to 24 hours following scan
  • Allergic to the tracer or any of its constituents and/or has a history of severe allergic reactions to drugs or allergens (e.g. patients with allergic asthma)
  • Critically ill and/or medically unstable and whose clinical course within the observation period is unpredictable, e.g. participants with 14 days of myocardial infarction or stroke, unstable participants with previous surgery (within 7 days), participants with advanced heart insufficiency (New York Heart Association (NYHA) stage IV), or participants with acute renal failure.
  • Has received any contrast material (X-ray, Magnetic Resonance Imaging (MRI)), or radiopharmaceuticals within 48 hours prior to the application of the Investigational Medicinal Product (IMP) or for whom application of such a substance is planned for 24 hours following IMP administration
  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: NCT01222351

Contacts
Contact: Greysi Sherwood 212-305-4630 gms2137@columbia.edu
Contact: Yaakov Stern, BA, PhD 212-342-1350 ys11@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Richard Mayeux, BS, MD, MSc    212-305-2391    rpm2@columbia.edu   
Contact: Yaakov Stern, BA, PhD    212-342-1350    ys11@columbia.edu   
Sponsors and Collaborators
Yaakov Stern
Bayer
Investigators
Principal Investigator: Richard Mayeux, BS, MD, MSc Columbia University
Study Chair: Yaakov Stern, BA, PhD Columbia University
Study Chair: Adam Brickman, BA, MA, PhD Columbia University
  More Information

Publications:
Responsible Party: Yaakov Stern, Sponsor, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01222351     History of Changes
Other Study ID Numbers: 6045 (Bayer), IND 78868, R01AG037212-01
Study First Received: October 14, 2010
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
Alzheimer's disease
Positron emission tomography
Biomarker
Plasma Aβ
Brain amyloid plaque load

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

ClinicalTrials.gov processed this record on September 16, 2014