Brain Imaging in the Diabetes Prevention Program Outcomes Study (DPPOS-Brain)

José A. Luchsinger

Status and phase: Terminated; Early Phase 1

Conditions: Alzheimer Disease

Treatments: Drug: 18F-MK-6240; Drug: 11C-PIB

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03757910

AAAS1176

3U01DK048404-25S1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

DPPOS Exposed to Metformin

Experimental group

Description:

DPPOS participants with exposure to metformin will be scanned with 18F-MK-6240 and 11C-PIB.

Treatment:

Drug: 11C-PIB

Drug: 18F-MK-6240

DPPOS Exposed to Placebo

Active Comparator group

Description:

DPPOS participants with no exposure to metformin but only placebo will be scanned with 18F-MK-6240 and 11C-PIB.

Treatment:

Drug: 11C-PIB

Drug: 18F-MK-6240