Brain Imaging in the Diabetes Prevention Program Outcomes Study



Status:Not yet recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:60 - Any
Updated:12/5/2018
Start Date:January 2019
End Date:August 2019
Contact:Jose A. Luchsinger, MD
Email:jal94@cumc.columbia.edu
Phone:212-305-4730

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Amyloid Brain Positron Emission Tomography (PET) Imaging With 11C-PIB and Tau PET Imaging With 18F-MK-6240 in the Diabetes Prevention Program Outcomes Study.

This is a cross-sectional pilot study of Alzheimer's disease (AD) brain imaging biomarkers in
Diabetes Prevention Program (DPP) outcomes study (DPPOS) participants from the New York City
sites (Columbia and Einstein), comparing 10 persons originally randomized to metformin and 10
persons randomized to placebo in DPP. All study procedures will be conducted at Columbia
University Irving Medical Center. Eligible participants will receive a PET scans and a brain
MRI, which may be conducted in one, two, or three separate visits.

Hyperinsulinemia is believed to increase the risk of Alzheimer's dementia through both
cerebrovascular and A related mechanisms, and this hypothesis has prompted testing strategies
related to hyperinsulinemia and diabetes in the prevention and treatment of Alzheimer's
dementia.These strategies usually entail improving insulin sensitivity to lower insulin and
glucose levels, such as lifestyle (diet and exercise) and metformin, which were effective
strategies for preventing diabetes in the DPPOS. There are conflicting data relating
metformin with increased AD risk, and this needs to be clarified in DPPOS. Several laboratory
and human studies have suggested that metformin increases the risk of Alzheimer's dementia,
but this is countered by other studies indicating that it is beneficial. Preliminary data in
humans and animals support the beneficial effects of metformin on Alzheimer's dementia risk.

Inclusion Criteria:

- Active participants in the Diabetes Prevention Program Outcomes Study (DPPOS) in New
York City originally randomized to metformin or placebo

- 60 years and older

Exclusion Criteria:

- Known dementia

- Contraindications to magnetic resonance imaging (MRI)

- Contraindications to radio-contrast agents.
We found this trial at
2
sites
630 W 168th St
New York, New York
212-305-2862
Principal Investigator: Jose A Luchsinger, MD
Phone: 212-305-4730
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1825 Eastchester Road
New York, New York 10461
Principal Investigator: Jill Crandall, MD
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