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| ID | Type | Description | Link |
|---|---|---|---|
| 3U01DK048404-25S1 | U.S. NIH Grant/Contract | View source |
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Difficulty recruiting due to the COVID-19 pandemic and end of funding
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| Name | Class |
|---|---|
| Albert Einstein College of Medicine | OTHER |
| George Washington University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DPPOS Exposed to Metformin | Experimental | DPPOS participants with exposure to metformin will be scanned with 18F-MK-6240 and 11C-PIB. |
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| DPPOS Exposed to Placebo | Active Comparator | DPPOS participants with no exposure to metformin but only placebo will be scanned with 18F-MK-6240 and 11C-PIB. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-MK-6240 | Drug | This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi). |
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| Measure | Description | Time Frame |
|---|---|---|
| Brain Amyloid SUVR | Whole brain amyloid (11C-PIB) standardized uptake volume ratio (SUVR) | Up to 1 hour post-injection |
| Brain Tau SUVR | Tau (18F-MK-6240) SUVR in medial and inferior temporal lobes | Up to 1 hour post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Hippocampal Cortical Thickness | Thickness in the hippocampal cortex | Up to 1 hour post-injection |
| White Matter Hyper Intensity Volume | Volume of brain white matter hyper-intensities |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose A. Luchsinger, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Irving Medical Center | New York | New York | 10032 | United States |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D018149 | Glucose Intolerance |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C475519 | 2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole |
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| 11C-PIB | Drug | This radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi. |
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| Up to 1 hour post-injection |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006943 | Hyperglycemia |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |