Brain Imaging in the Diabetes Prevention Program Outcomes Study

• Status: Enrolling by invitation
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: José A. Luchsinger
• Collaborators: Albert Einstein College of Medicine; Albert Einstein College of Medicine, Inc.; George Washington University; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Corticosterone; Metformin

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.