DPPOS-Brain: Brain Imaging in the Diabetes Prevention Program Outcomes Study
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Early Phase 1 |
Detailed Description
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: DPPOS Exposed to Metformin DPPOS participants with exposure to metformin will be scanned with 18F-MK-6240 and 11C-PIB. |
Drug: 18F-MK-6240
This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi).
Drug: 11C-PIB
This radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi.
Other Names:
|
Active Comparator: DPPOS Exposed to Placebo DPPOS participants with no exposure to metformin but only placebo will be scanned with 18F-MK-6240 and 11C-PIB. |
Drug: 18F-MK-6240
This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi).
Drug: 11C-PIB
This radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Brain Amyloid SUVR [Up to 1 hour post-injection]
Whole brain amyloid (11C-PIB) standardized uptake volume ratio (SUVR)
- Brain Tau SUVR [Up to 1 hour post-injection]
Tau (18F-MK-6240) SUVR in medial and inferior temporal lobes
Secondary Outcome Measures
- Hippocampal Cortical Thickness [Up to 1 hour post-injection]
Thickness in the hippocampal cortex
- White Matter Hyper Intensity Volume [Up to 1 hour post-injection]
Volume of brain white matter hyper-intensities
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Columbia University Medical Center | New York | New York | United States | 10032 |
2 | Albert Einstein College of Medicine | New York | New York | United States | 10461 |
Sponsors and Collaborators
- José A. Luchsinger
- Albert Einstein College of Medicine
- George Washington University
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: F. X. Pi-Sunyer, MD, Columbia University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AAAS1176
- 3U01DK048404-25S1