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18F-MK6240 injection for Type 2 Diabetes (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

NOMEM-Tau Trial 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.Check my eligibility

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.See study design

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.

NOMEM-Tau Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

18F-MK6240 standardized update value ratio (SUVR)

NOMEM-Tau 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

Find a Location

Who is running the clinical trial?

Columbia UniversityLead Sponsor

1,432 Previous Clinical Trials

2,460,373 Total Patients Enrolled

Hebrew Home at RiverdaleOTHER

5 Previous Clinical Trials

1,893 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,671 Previous Clinical Trials

28,016,463 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential adverse effects can be associated with 18F-MK6240 injections?

"Due to the lack of evidence regarding efficacy, 18F-MK6240 injection is rated a 2 on our safety scale. However, there are some data points that suggest acceptable levels of safety for this chemical compound."

Answered by AI

Is there any way I could partake in this medical investigation?

"This investigation requires 500 test subjects of ages 55 to 69 with type 2 diabetes mellitus. Additionally, they must reside in Northern Manhattan, self-identify as Hispanic, non-Hispanic Black or non-Hispanic White and be free from dementia while being able to fulfill all necessary evaluations and tests/procedures."

Answered by AI

Are there any remaining vacancies for participants in this experiment?

"As per clinicaltrials.gov, this research trial is not currently accepting new participants. After its initial post on July 24th 2018 and most recent edit on July 8th 2021, the study has concluded recruitment; however, 1500 other studies are still actively seeking candidates at this time."

Answered by AI