Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2026-02-08 @ 11:26 PM
Study NCT ID:
NCT03919669
Status:
COMPLETED
Last Update Posted:
2023-08-03
First Post:
2019-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Longitudinal Evaluation of a Radiotracer for Use in Tau Tracking
Sponsor:
University of Wisconsin, Madison
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: