Enrolling by invitationPhase 2

Brain Scan Study of Tau Protein in People With Diabetes or Pre-diabetes

Tests a tau brain scan agent in adults with diabetes or pre-diabetes.

Key facts

Who runs it: Columbia University
Where: New York, United StatesSee the site
Trial code: NCT03389100
Registry title: Tau PET Imaging in the Northern Manhattan Study of Metabolism and Mind.
Status: Enrolling by invitation
Phase: Phase 2
People taking part: 600 people, planned
Started: 24 Jul 2018
Planned end: Jun 2026
Type of study: Interventional
Treatments tested: 18F-MK6240 injection
Record updated: 6 May 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 55 to 69 who live in Northern Manhattan and do not have dementia. They must have had, or agreed to have, a brain MRI and a brain amyloid PET scan.

Age: 55 to 69 years
Sex: Women and men can join.
Disease stage: No dementia. The study looks at diabetes and pre-diabetes and brain changes.
Biomarker or test result: Must have had, or agreed to have, a brain MRI and a Florbetaben PET scan.

Main reasons for not taking part

Dementia diagnosis
Serious medical conditions that make the study procedures unsafe, such as uncontrolled epilepsy or liver cirrhosis
Cannot have an MRI scan, or cannot enter the scanner (for example claustrophobia)
Cannot have a catheter placed in a vein or cannot have blood drawn
Pregnancy or breastfeeding

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

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

Who cannot take part

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
Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.)
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
Contraindication to MRI scanning
Inability to have a catheter in subject's vein for the injection of radioligand
Inability to have blood drawn from subject's veins

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 55 and 69 years old?

Where in United States

Columbia University Irving Medical CenterNew York, United StatesNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

18F-MK6240 injectionTreatment being tested
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)