Tau PET Imaging for Metabolic Health

(NOMEM-Tau Trial)

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Columbia University

Disqualifiers: Dementia, Uncontrolled epilepsy, Liver cirrhosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how diabetes and blood sugar levels might affect brain health, focusing on a protein called tau. Participants will receive an injection of 18F-MK6240, a special substance that helps capture brain images during a PET scan, conducted twice over 18 to 30 months. The study seeks individuals aged 55 to 69 from Northern Manhattan who identify as Hispanic, non-Hispanic Black, or non-Hispanic White and have already had or agreed to have brain imaging tests. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this PET imaging method is safe?

Research has shown that the 18F-MK6240 injection is generally safe for people. In one study, participants tolerated this tracer well, and researchers found no safety issues. Those who received the 18F-MK6240 injection did not experience serious side effects.

Participants in various studies have safely undergone PET scans using this tracer. While the safety results are encouraging, individual experiences can vary. It is important to consult a healthcare professional if there are any concerns about joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the 18F-MK6240 injection because it offers a new way to assess tau protein build-up in the brain, which can be an indicator of conditions like Alzheimer's disease. Unlike standard imaging techniques, this method uses a radioactive tracer specifically designed to bind to tau proteins, allowing for more precise imaging of their distribution and concentration. This could lead to earlier and more accurate diagnosis of neurodegenerative diseases, potentially opening doors to more targeted treatments in the future.

What evidence suggests that 18F-MK6240 injection is effective for brain tau imaging?

Research has shown that 18F-MK6240, which participants in this trial will receive, is a promising tool for PET scans to detect tau, a protein linked to Alzheimer's disease. Studies have found that it adheres well to tau filaments, effectively showing where tau accumulates in the brain. This tracer is often used in clinical trials because it provides clear images of tau, especially in older adults. Early results suggest that 18F-MK6240 can help researchers understand how tau accumulates over time, potentially connecting to memory and thinking problems. This makes it a valuable tool in brain imaging studies focused on tau's role in diseases. ^{1 2 6 7 8}

Who Is on the Research Team?

Jose A. Luchsinger, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

This trial is for people aged 55-69 living in Northern Manhattan who self-identify as Hispanic, non-Hispanic Black, or Non-Hispanic White. Participants must be fluent in English/Spanish, without dementia, and have agreed to brain scans (MRI & amyloid PET). Exclusions include serious chronic conditions like liver cirrhosis or renal failure, MRI contraindications, severe injuries, claustrophobia, inability to draw blood or have a catheter inserted.

Inclusion Criteria

I am between 55 and 69 years old.

Without dementia

Living in Northern Manhattan

Exclusion Criteria

Breastfeeding women will be excluded, although this situation is expected to be rare

I have been diagnosed with dementia.

I cannot have a catheter placed in my vein for treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging Procedures

Participants undergo brain MRI and PET scans with 18F-MK-6240

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

18 to 30 months

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 18F-MK6240 injection

Trial Overview The study tests the relationship between diabetes status and brain tau accumulation using an injection of a tracer called 18F-MK6240 with PET scans. Participants will undergo two PET scans about 18-30 months apart to measure changes in tau levels across different ethnicities and races.

How Is the Trial Designed?

Group I: 18F-MK6240 injection Experimental Treatment 1 Intervention

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)

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Hebrew Home at Riverdale

Collaborator

Trials

6

Recruited

2,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

3H-MK6240, a second-generation tau PET tracer, shows high binding affinity for neurofibrillary tangles in Alzheimer's disease (AD) brain tissue, with significantly higher binding observed in AD patients compared to controls.

The study found that 3H-MK6240 has distinct binding characteristics compared to first-generation tau tracers, indicating its potential for more accurate detection of tau deposits in AD, particularly in early-onset cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterization of MK6240, a tau PET tracer, in autopsy brain tissue from Alzheimer's disease cases. Malarte, ML., Nordberg, A., Lemoine, L.[2021]

The PET imaging agent [18F]MK6240 effectively detects tau aggregates in the brain, showing a wide dynamic range of uptake in subjects with mild cognitive impairment (MCI) and Alzheimer's Disease (AD), which aligns with known patterns of tau deposition.

While various quantification methods for [18F]MK6240 were tested, including compartmental and reference tissue models, caution is advised in using simplified methods for high binding cases due to potential underestimation of tau levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of pharmacokinetic modeling strategies for in-vivo quantification of tau with the radiotracer [18F]MK6240 in human subjects. Guehl, NJ., Wooten, DW., Yokell, DL., et al.[2023]

The PET tracer 18F-PI-2620 effectively detects tau pathology in Alzheimer's disease patients, showing significantly higher binding in brain regions associated with tau deposition compared to healthy controls, indicating its potential as a diagnostic tool.

The administration of 18F-PI-2620 was found to be safe and well tolerated, with imaging results demonstrating a strong correlation between tau uptake and cognitive impairment, suggesting its utility in assessing disease severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tau PET imaging with 18F-PI-2620 in Patients with Alzheimer Disease and Healthy Controls: A First-in-Humans Study. Mueller, A., Bullich, S., Barret, O., et al.[2022]

The novel tau-PET radiotracer [18F]PI-2620 shows strong potential as a surrogate biomarker for neuronal injury, correlating well with traditional [18F]FDG-PET imaging in a study of 26 subjects with suspected tauopathies.

Early-phase imaging of [18F]PI-2620 (0.5 to 2.5 minutes post-injection) demonstrated high agreement with [18F]FDG-PET, suggesting that it could replace the need for additional [18F]FDG-PET imaging in assessing both tau distribution and neuronal injury.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early-phase [18F]PI-2620 tau-PET imaging as a surrogate marker of neuronal injury. Beyer, L., Nitschmann, A., Barthel, H., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9166561/

18F-MK-6240 tau-PET in genetic frontotemporal dementia The recently developed 18F-MK-6240 tau-PET tracer is one of the second-generation tracers that has shown promising results not only in vitro and in animals, but ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03071224

Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging ... The overall goal of this protocol is to evaluate [18F]MK-6240 (also known as [18F]MNI-946) a tau targeted radiopharmaceutical.

3. thelancet.com thelancet.com/journals/ebiom/article/PIIS2352-3964(23)00015-4/fulltext

Rates of regional tau accumulation in ageing and across ... 18 F-MK6240 is a high affinity tracer for the paired helical filaments of tau in AD, widely used in clinical trials, despite sparse longitudinal natural ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/64/3/452

The Association of Age-Related and Off-Target Retention with ... [ 18 F]MK6240 has age-related retention in subcortical regions, at a much lower magnitude but topographically colocalized with significant off-target signal.

5. link.springer.com link.springer.com/article/10.1007/s00259-024-06603-2

The spatial extent of tauopathy on [ 18 F]MK-6240 tau PET ... Our study aimed to evaluate whether cognitive impairment would be more closely associated with the spatial extent than with the intensity of tau-PET signal.

6. molecularneurodegeneration.biomedcentral.com molecularneurodegeneration.biomedcentral.com/articles/10.1186/s13024-025-00808-1

18F-MK-6240 tau PET in patients at-risk for chronic traumatic ... Molecular biomarkers of chronic traumatic encephalopathy (CTE) are lacking. We evaluated 18F-MK-6240 tau PET as a biomarker for CTE.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9902412/

Dosimetry and efficacy of a tau PET tracer [18F]MK-6240 in ... The data showed that [18F]MK-6240 had no safety concerns and was well tolerated. Because there might be ethnic differences in pharmacokinetics ...

8. jnm.snmjournals.org jnm.snmjournals.org/content/early/2025/01/02/jnumed.124.268623

In Vivo Head-to-Head Comparison of [18F]GTP1 with [18F] ... Our findings indicate that [ 18 F]GTP1, [ 18 F]PI-2620, and [ 18 F]MK-6240 display similar uptake patterns in AD patients, suggesting that they detect the same ...