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

NCT03389100 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 600

Last updated 2025-05-06

No results posted yet for this study

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 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.

Conditions

  • Diabetes Mellitus, Type 2
  • Pre-diabetes

Interventions

DRUG

18F-MK6240 injection

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)

Sponsors & Collaborators

  • Hebrew Home at Riverdale

    collaborator OTHER

  • National Institute on Aging (NIA)

    collaborator NIH

  • Columbia University

    lead OTHER

Principal Investigators

  • Jose A. Luchsinger, MD · Columbia University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
55 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03389100 on ClinicalTrials.gov