Biomarkers

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ResearchersAgainstAlzheimer's would like to thank Roche Diagnostics for their support of this project.

[18F]MK-6240 ([18F]MNI-946)

Method of Measurement (Pre-analytical Tools)
Imaging
Biomarker Measured
Tau
Use
Monitoring
Pharmacodynamic/response
Susceptibility/risk
Stage of Development
Clinical trials
Active vs Completed Trials
Active
Aim/Results

Evaluate [18F]MK-6240 (also known as [18F]MNI-946) a tau targeted radiopharmaceutical. Furthermore, this study aims to: measure the dynamic uptake and washout of [18F]MK-6240 in brain using positron emission tomography (PET) in patients with Alzheimer's disease and healthy volunteers, measure blood metabolites of [18F]MK-6240 and perform kinetic modeling to assess its ability to measure tau protein in brain using the tracer plasma concentration or a reference region as indirect input, obtain test/retest reliability of the tracer binding parameters in patients with Alzheimer's disease and healthy volunteers (HV) (Cohort 1), acquire safety data following injection of [18F]MK-6240, determine the longitudinal change in tau burden (including SUVR and tau distribution metrics) compared to baseline in AD subjects and in similarly aged HV subjects, evaluate the correlation between the longitudinal change in tau burden and change in clinical, MRI and CSF biomarker measures in AD subjects and in similarly-aged HV subjects, and, further explore the relationship between tracer metabolism and smoking (Cohort 3).

Target Population/ Population Being Studied

12 AD and 3 HV subjects in Cohort 1, 8 AD and 2 HV subjects in Cohort 2, and 3 AD and 3 HV subjects in Cohort 3.

Length of Current Trial
1 year
Number of Trial Participants

15

Estimated Trial Completion
June 2020
What is Required from Patients

injection of radioactive tracers, mild discomfort, in clinic visit

What is Required from the Health System

PET technician, PET scanner, dyes

Sponsor

Invicro

  1. “Phase 1 Evaluation of [18F]MK-6240 PET as an Imaging Marker for Tau Protein.” ClinicalTrials.gov. Accessed October 9, 2019. https://clinicaltrials.gov/ct2/show/NCT03071224?term=biomarker&recrs=abdf&cond=Alzheimer+Disease&draw=4&rank=34

  2. “Study of Tau Imaging With the Use of [18F]MK-6240 Tracer (MKADAD).” ClinicalTrials.gov. Accessed October 11, 2019. https://clinicaltrials.gov/ct2/show/NCT04104659?term=biomarker&recrs=adf&cond=Alzheimer+Disease&draw=20&rank=165