CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
All Subjectsdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03919669
NCT03919669Phase 2Completed

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

University of Wisconsin, Madison·interventional·Posted Apr 18, 2019·Updated Aug 3, 2023

In Brief

A Phase 2 clinical trial evaluating All Subjects for Alzheimer Disease and Mild Cognitive Impairment. Completed, enrolled 27 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedApr 18, 2019
Enrollment StartApr 2, 2019
Primary CompletionMay 19, 2022
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 7.2 years ago

Interventions

All Subjectsdrug

All subjects will be given the experimental tau PET radioligand \[18F\]MK-6240