Tau PET Imaging in the Northern Manhattan Study of Metabolism and Mind.

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT03389100
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 69 Years
Healthy Volunteers
Accepted

Interventions

  • 18F-MK6240 injection — DRUG
    Intravenous injection of 18F-MK-6240, up to 5 mCi (185 MBq), total of one injection per PET scan (2 injections in total with an interval of 18 to 30 months)

Study Details

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.

Key Dates

Start date
Jul 24, 2018
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
600 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 18F-MK6240 injection
    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)

Primary Outcome Measure

18F-MK6240 standardized update value ratio (SUVR) [ Time Frame: 18 to 30 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Irving Medical CenterNew YorkNew York10032-

Find similar trials in New York, NY

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Columbia University Irving Medical Center· New York, NY

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