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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
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)
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Who is running the clinical trial?
Columbia UniversityLead Sponsor
1,492 Previous Clinical Trials
2,664,258 Total Patients Enrolled
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5,484 Patients Enrolled for Diabetes
Hebrew Home at RiverdaleOTHER
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1,893 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,793 Previous Clinical Trials
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767,049 Patients Enrolled for Diabetes
Jose A. Luchsinger, MDPrincipal InvestigatorColumbia University
2 Previous Clinical Trials
1,005 Total Patients Enrolled
1 Trials studying Diabetes
1,000 Patients Enrolled for Diabetes
Jose A Luchsinger, MDPrincipal InvestigatorColumbia University
5 Previous Clinical Trials
1,627 Total Patients Enrolled
1 Trials studying Diabetes
1,000 Patients Enrolled for Diabetes