NCT03919669

A Longitudinal Evaluation of a Radiotracer for Use in Tau Tracking

Longitudinal Evaluation of [18-F]MK-6240 as a Novel Tau PET Radiotracer in Patients With Alzheimer's Disease Dementia or Mild Cognitive Impairment Compared to Healthy Volunteers

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This is a longitudinal, observational study evaluating the imaging characteristics of the tau PET radioligand \[18F\]MK-6240 in Alzheimer's disease (AD), Mild Cognitive Impairment (MCI) and Healthy Volunteer (HV) subjects. Up to 42 subjects, including approximately 28 MCI/mild AD subjects, up to 5 moderate AD subjects, and 9 similarly aged HV subjects will be consented and screened. Imaging procedures include \[11C\]PiB to evaluate amyloid deposition, \[18F\]MK-6240 PET, and structural MRI. All subjects complete an evaluable baseline \[18F\]MK-6240 PET scan, as well as scans at 6, 12 and 24 months post-baseline. If unable to complete the 6 month, 12 month, or 24 month visit, an 18 month and/or 30 month visit may instead be scheduled, totaling a maximum of four time points.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	All Subjects	All subjects will be given the experimental tau PET radioligand \[18F\]MK-6240

Timeline

• Start date: 2019-04-02
• Primary completion: 2022-05-19
• Completion: 2022-05-19
• First posted: 2019-04-18
• Last updated: 2023-08-03
• Results posted: 2023-08-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study