Biomarkers

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ResearchersAgainstAlzheimer's would like to thank Roche Diagnostics for their support of this project.
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[18F]MNI-958 (APN-0000455; PM-PBB3)

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

Evaluate [18F]MNI-958 also known as APN-0000455 or PM-PBB3, a tau targeted radiopharmaceutical. The specific objectives are to: 1. measure the dynamic uptake and washout of [18F]MNI- 958 in brain using positron emission tomography (PET) in patients with Alzheimer's disease, Progressive Supranuclear Palsy and healthy volunteers; 2. measure blood metabolites of [18F]MNI-958 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, and 3.obtain test/retest reliability of the tracer binding parameters in patients with Alzheimer's disease, Progressive Supranuclear Palsy and healthy volunteers To acquire safety data following injection of [18F]MNI-958.

Target Population/ Population Being Studied

Patients with Alzheimer's disease and probable PSP and healthy volunteers

Length of Current Trial
1 year
Number of Trial Participants

14

Estimated Trial Completion
March 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

“Phase 1 Test-retest Evaluation of [18F]MNI-958 PET.” ClinicalTrials.gov. Accessed October 8 2019. https://clinicaltrials.gov/ct2/show/NCT03545789?term=biomarker&recrs=abdf&cond=Alzheimer+Disease&draw=9&rank=75