Status:
ENROLLING_BY_INVITATION
Tau PET Imaging in the Northern Manhattan Study of Metabolism and Mind.
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Hebrew Home at Riverdale
National Institute on Aging (NIA)
Conditions:
Diabetes Mellitus, Type 2
Pre-diabetes
Eligibility:
All Genders
55-69 years
Phase:
PHASE2
Brief Summary
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 N...
Detailed Description
1. Subject recruitment and screening procedures. Subjects will be recruited from community dwelling persons from Northern Manhattan, men and women, aged 55 to 69 years, who have already undergone or a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Contraindication to MRI scanning
- Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
- Inability to have a catheter in subject's vein for the injection of radioligand.
- Inability to have blood drawn from subject's veins.
- 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
Key Trial Info
Start Date :
July 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT03389100
Start Date
July 24 2018
End Date
June 1 2026
Last Update
May 6 2025
Active Locations (1)
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1
Columbia University Irving Medical Center
New York, New York, United States, 10032