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

Phase 2

Waitlist Available

Led By Jose A. Luchsinger, MD

Research Sponsored by Columbia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 to 30 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at how well 18F-MK-6240 works in people without dementia who are from Northern Manhattan and are Hispanic, non-Hispanic Black, or Non-Hispanic White.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from the injection may include reactions at the injection site or allergic responses. Vital signs are monitored before and after the scan to ensure safety. The study does not detail specific side effects of 18F-MK6240 but monitoring suggests they are cautious of any adverse events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 to 30 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 to 30 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 to 30 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

18F-MK6240 standardized update value ratio (SUVR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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)

Do I qualify?Apply below to find out