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Diabetes Mellitus, Type 2Phase 2NOMEM-TauNCT03389100

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

A Phase 2 study testing 18F-MK6240 injection in people with Diabetes Mellitus, Type 2 and Pre-diabetes, run by Columbia University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 55 to 69 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2, Pre-diabetes
What is being tested?
18F-MK6240 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteUnited States
Study dates
24 Jul 2018to Jun 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 69 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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 join

  • 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.
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Columbia University Irving Medical Center

    New York, New York, 10032

Other trials in United States

About this study

Official title: Tau Positron Emission Tomography (PET) Imaging in the Northern Manhattan Study of Metabolism and Mind (NOMEM) With 18F-MK6240.

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.

Read the 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 agreed to undergo, brain magnetic resonance imaging (MRI) and Florbetaben positron emission tomography (PET) as part of Columbia IRB protocol AAAQ2950 (PI: Luchsinger). Recruitment of participants for these studies and all study procedures, including brain MRI, Florbetaben PET, and tau PET, are funded by existing grant from the National Institutes of Health awarded to PI Luchsinger (R01AG050440, RF1AG051556-01S2, R01AG055299)
  2. Imaging procedures related to 18F-MK-6240 PET. One brain MRI will be performed on each subject using a 3 T Philips scanner. Sequences performed will include 3D T1 (MPRAGE, 180 slice 1 mm resolution, 256 x 256 voxel count) for volumetric analysis and clinical sequences to exclude subjects with significant intracranial pathology unrelated to AD, such as malignant brain tumor of subdural hematoma. PET scans will take place on a Biograph mCT PET scanner (Siemens Healthcare) at the CUMC Kreitchman PET Center. Subjects will have one PET scan with 18F-MK-6240 (injected activity up to 5 mCi = 185 MBq). PET imaging will be performed without arterial sampling. Vital signs (blood pressure, heart rate, respiratory rate, and temperature) will be checked prior to injection of 18F-MK-6240, then at the completion of the PET scan. 18F-MK-6240 will be purchased from Cerveau Technologies, Inc. via a licensed production facility. Subjects will not be informed of 18F-MK-6240 PET scan results, as this scan is used only in research and have not yet been validated for clinical use. Subjects will be informed if a clinically important abnormality is detected on MRI or PET imaging (e.g., brain tumor).
  3. Image processing FreeSurfer (http://surfer.nmr.mgh.harvard.edu/), the MRI software package comprising a suite of automated tools for segmentation, reconstruction, and derivation of regional volumes and surface-based rendering, will be used for derivation of regions-of-interest (ROIs). Eleven ROIs will be extracted from the structural T1 image: entorhinal cortex, hippocampus, inferior temporal cortex, combined superior and middle temporal cortex, superior parietal lobule, inferior parietal lobule, precuneus, occipital cortex, prefrontal cortex, striatum, and thalamus. 18F-MK-6240 PET images will be analyzed as follows: Freesurfer based ROIs will be applied to coregistered PET images. Correction for partial volume effects using a region-based voxel-wise method92 will be applied to compare to partial volume uncorrected data. Regional time-activity curves will be extracted from the PET scans, including cerebellum which will be used as a reference region. Standardized uptake value ratio (SUVR) values will be calculated by dividing SUV values for each target region by that of the cerebellum. Alternative analytic methods such as Logan DVR and Simplified Reference Tissue Method may also be applied to compare to SUVR data.
Being tested
18F-MK6240 injection
Keywords
diabetes, hyperglycemia, tau
Medical subject headings
Diabetes Mellitus, Type 2, Glucose Intolerance, Diabetes Mellitus, Hyperglycemia, Pick Disease of the Brain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 18F-MK6240 injectionDrug

    Also called MK6240

    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 groups in NCT03389100
Study groupRoleWhat they receive
18F-MK6240 injectionExperimentalintravenous 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)
Receives: Drug: 18F-MK6240 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 18 to 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jan 2018
  2. Study start24 Jul 2018
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03389100
Sponsor's protocol ID
AAAR1419b
Other IDs
R01AG050440, R01AG055299, RF1AG051556
Acronym
NOMEM-Tau
Status last verified
May 2025
First submitted
27 Dec 2017
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: We plan to share data with the data sharing platform of the NIA consortium named "Molecular Mechanisms of the Vascular Etiology of Alzheimer's disease (M2OVE-AD)" for data collection supported by grant RF1AG051556. This data sharing platform is called Synapse, and is managed by SAGE bionetworks. The main data from this protocol to be shared are summary values of brain Tau SUVR, demographics, and clinical variables such as diabetes status.

Publications

  • 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.

    PubMed 33894641

  • 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.

    PubMed 34057284

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 18F-MK6240 injection in people with Diabetes Mellitus, Type 2 and Pre-diabetes, run by Columbia University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

18F-MK6240 standardized update value ratio (SUVR) (time frame: 18 to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03389100, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2025.

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