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Diabetes Mellitus, Type 2Diagnostics and screeningDrugPhase 2

What this study is

This is a single center brain Positron Emission Tomography (PET) study of 18F-MK-6240. Eligible participants are persons from Northern Manhattan who self-identify as Hispanic, non-Hispanic Black, or Non-Hispanic White, who are 55 to 69 years of age, of both sexes, without dementia, who have already agreed to undergo, of have undergone, brain amyloid PET and magnetic resonance imaging (MRI). Those eligible will have one brain PET scan with 18F-MK-6240, repeated after 18 months to 30 months. Vital signs will be checked prior to injection of 18F-MK-6240 and again at the completion of the PET scan. The primary objective is to relate diabetes status and glycemia to in-vivo brain tau accumulation, across and within ethnic and racial groups.

What's being tested

  • 18F-MK6240 injection

    Intervention · DRUG

    Intravenous injection of 18F-MK-6240, up to 5 mCi (185 MBq), total of one injection per PET scan (2 injections in total with an interval of 18 to 30 months)

Study details

Official title
Tau Positron Emission Tomography (PET) Imaging in the Northern Manhattan Study of Metabolism and Mind (NOMEM) With 18F-MK6240.
Sponsor
Columbia University
Conditions
Diabetes Mellitus, Type 2 · Pre-diabetes
Enrolling
600 people
Starts
2018-07-24
Est. completion
2026-06
Design
Open-label, single group, Phase 2
Record
View on ClinicalTrials.gov ↗