BAY 94-9172 PET/CT in Cognitively Normal Older Adults, Older Adults With Mild Cognitive Impairment, and Older Adults With Alzheimer's Disease
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10032 |
| Conditions: |
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Late Onset Alzheimer Disease |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT01222351 |
| Primary Contact: |
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Principal Investigator
Richard Mayeux, BS, MD, MSc
Columbia University
Irene M Martin-Alciati, BA
Phone: 212-305-4630
Email: im2349@columbia.edu
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| Backup Contact: |
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Email: ys11@columbia.edu
Yaakov Stern, BA, PhD
Phone: 212-342-1350
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| Location Contact: |
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New York, New York 10032
United States
Richard Mayeux, BS, MD, MSc
Phone: 212-305-2391
Email: rpm2@columbia.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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