Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2026-01-01 @ 12:29 PM
Study NCT ID:
NCT05427656
Status:
UNKNOWN
Last Update Posted:
2022-07-21
First Post:
2022-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Imaging Biomarkers of Neuroplasticity and Neurodegeneration in the Living Human Brain
Sponsor:
Thiel, Alexander, M.D.
Organization:
Study Overview
Official Title:
Imaging Biomarkers of Neuroplasticity and Neurodegeneration in the Living Human Brain (Uptake, Distribution and Pharmacokinetic) Study
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
NOT_YET_RECRUITING
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:
F18TRACK
Brief Summary:
Following our recently completed whole body dosimetry study for \[18F\] TRACK in 6 healthy control subjects, the objective of this project is to evaluate brain uptake, regional distribution and in vivo pharmacokinetics for \[18F\] TRACK in 30 cognitively healthy controls using dynamic PET imaging. Specifically, we will evaluate \[18F\] TRACK in three cohorts of healthy control subjects of different ages and both sexes to further explore tracer kinetics in vivo and to determine the most appropriate and robust model to estimate tracer binding to TrkB/C. This will assess normal TrkB/C density in vivo and provide normative data for future use of these tracers in patients.
Detailed Description:
We propose to use the radiotracer \[18F\] TRACK to non-invasively image the concentration of TrkB/C in the living human brain with Positron Emission Tomography in 3 different age cohorts. The different subgroups of healthy controls will be used to define the best quantification method for our TrkB/C ligands and to assess a possible age dependency of TrkB/C binding in the healthy population, that may be of particular importance for the future study of patients with Alzheimer's Disearse or mild cognitive impairment. We expect the proposed study to result in 1) a non-invasive method to quantify TrkB/C receptor binding in vivo, 2) age-specific norms of TrkB/C concentration and 3) a simplified approach for quantification which best approximates the full model without the need for arterial blood sampling for future use in patients.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: