Tau Positron Emission Tomography (PET) Imaging in the Northern Manhattan Study of Metabolism and Mind (NOMEM) With 18F-MK6240.

AAAR1419b

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.

2018-07-24

2026-06-01

2026-06-01

Early phase I

600

Inclusion Criteria: 1. Age 55 to 69 years 2. Without dementia 3. Fluent in English and/or Spanish. 4. Living in Northern Manhattan. 5. Self-identified as Hispanic, non-Hispanic Black, or non-Hispanic White. 6. Already had or agreed to have a brain MRI and Florbetaben PET. 7. Able to participate in all scheduled evaluations and to complete all required tests and procedures. Exclusion Criteria: 1. Dementia diagnosis 2. Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries. 3. 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. 4. Contraindication to MRI scanning 5. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.). 6. Inability to have a catheter in subject's vein for the injection of radioligand. 7. Inability to have blood drawn from subject's veins. 8. 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Study subjects will receive a single injection of 18F-MK6240 for tau positron emission tomography (PET) imaging two times, separated by an interval between 18 and 30 months.', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}

2024-03-04