NCT03389100Enrolling by invitationPhase 2
Tau PET Imaging in the Northern Manhattan Study of Metabolism and Mind.
Tau Positron Emission Tomography (PET) Imaging in the Northern Manhattan Study of Metabolism and Mind (NOMEM) With 18F-MK6240.
Source: ClinicalTrials.gov · Last updated 6 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 600 (estimated)
- First submitted
- 27 Dec 2017
- Start date
- 24 Jul 2018
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Columbia University
- Diseases
- Type 2 diabetes
- NCT number
- NCT03389100
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 600
- From 24 Jul 2018 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Dementia diagnosis
- Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
- Persons with serious chronic conditions (e.g. Liver Cirrhosis, renal failure), which, in the opinion of the investigator, could increase the risk of un-anticipated adverse events.
- Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
Age
- Women in the age group that we are recruiting are highly unlikely to be pre-menopausal, and thus, highly unlikely to be menstruating. However, we will ask all women if they are post-menopausal, and in the rare case that they are not, we will conduct a urine pregnancy test to rule out pregnancy.
- Breastfeeding women will be excluded, although we expect this situation to be rare
Other
- Contraindication to MRI scanning
- Inability to have a catheter in subject's vein for the injection of radioligand.
- Inability to have blood drawn from subject's veins.
Who the study is looking for
- Age 55 to 69 years
- Without dementia
- Fluent in English and/or Spanish.
- Living in Northern Manhattan.
- Self-identified as Hispanic, non-Hispanic Black, or non-Hispanic White.
- Already had or agreed to have a brain MRI and Florbetaben PET.
- Able to participate in all scheduled evaluations and to complete all required tests and procedures.
Age in the registry: 55 years to 69 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.