Tau PET Imaging for Metabolic Health (NOMEM-Tau Trial)

Palo Alto (17 mi)

Overseen byJose A. Luchsinger, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Columbia University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people aged 55-69 living in Northern Manhattan who self-identify as Hispanic, non-Hispanic Black, or Non-Hispanic White. Participants must be fluent in English/Spanish, without dementia, and have agreed to brain scans (MRI & amyloid PET). Exclusions include serious chronic conditions like liver cirrhosis or renal failure, MRI contraindications, severe injuries, claustrophobia, inability to draw blood or have a catheter inserted.

Treatment Details

The study tests the relationship between diabetes status and brain tau accumulation using an injection of a tracer called 18F-MK6240 with PET scans. Participants will undergo two PET scans about 18-30 months apart to measure changes in tau levels across different ethnicities and races.

1Treatment groups

Experimental Treatment

Group I: 18F-MK6240 injectionExperimental Treatment1 Intervention

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