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

NCT03389100 | Enrolling By Invitation Phase 2 FDA Drug

• 4 other identifiers: AAAR1419bR01AG050440R01AG055299RF1AG051556
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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 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

Keywords

diabetes; hyperglycemia; tau

Outcome Measures

Primary Outcomes (1)

• 18F-MK6240 standardized update value ratio (SUVR)

  The primary outcome measure will be regional standardized uptake value ratio (SUVR) values for 18F-MK-6240 using cerebellum as reference region. Kinetic modeling using Logan DVR method may also be employed. Multiple brain regions will be measured, with particular attention to medial temporal cortex structures such as hippocampus and entorhinal cortex

  18 to 30 months

Study Arms (1)

18F-MK6240 injection

EXPERIMENTAL

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)

Drug: 18F-MK6240 injection

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)

Also known as: MK6240

18F-MK6240 injection

Eligibility Criteria

• Age: 55 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Hebrew Home at Riverdale: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• Palta P, Rippon B, Tahmi M, Pardo M, Johnson A, Tomljanovic Z, He H, Laing KK, Razlighi QR, Teresi JA, Moreno H, Brickman AM, Kreisl WC, Luchsinger JA. Sex differences in in vivo tau neuropathology in a multiethnic sample of late middle-aged adults. Neurobiol Aging. 2021 Jul;103:109-116. doi: 10.1016/j.neurobiolaging.2021.03.007. Epub 2021 Mar 23.

  PMID: 33894641 BACKGROUND

• Kreisl WC, Lao PJ, Johnson A, Tomljanovic Z, Klein J, Polly K, Maas B, Laing KK, Chesebro AG, Igwe K, Razlighi QR, Honig LS, Yan X, Lee S, Mintz A, Luchsinger JA, Stern Y, Devanand DP, Brickman AM. Patterns of tau pathology identified with 18 F-MK-6240 PET imaging. Alzheimers Dement. 2022 Feb;18(2):272-282. doi: 10.1002/alz.12384. Epub 2021 May 31.

  PMID: 34057284 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Diabetes Mellitus; Hyperglycemia; Pick Disease of the Brain

Interventions

MK-6240

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Frontotemporal Dementia; Frontotemporal Lobar Degeneration; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Jose A. Luchsinger, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 3, 2018
• Study Start: July 24, 2018
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be released twice a year to SAGE bionetworks for sharing.
• Access Criteria: Synapse operates under comprehensive governance policies. These policies delineate Synapse users' rights and responsibilities. They also specify the rights and responsibilities of Sage Bionetworks and of the Synapse Access and Compliance Team (ACT).

Locations

US (1)