Imaging Biomarkers of Neuroplasticity and Neurodegeneration in the Living Human Brain

NCT05427656 | Unknown Phase 1

• 1 other identifier: MP-05-2023-3358
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Normal Healthy Adults

Outcome Measures

Primary Outcomes (2)

• Non-invasive method to quantify TrkB/C receptor binding in vivo

  Non-invasive method to quantify TrkB/C receptor binding in vivo

  One Year

• Age-specific norms of TrkB/C concentration

  Age-specific norms of TrkB/C concentration

  One Year

Secondary Outcomes (1)

• Arterial Input Function with Non-Invasive Detector

  2 months

Study Arms (1)

185 MBq [18F] TRACK

EXPERIMENTAL

Each participant will receive a single scan with 185 MBq \[18F\] TRACK

Radiation: [18F] TRACK; Device: Measurement of Arterial Input Function

Interventions

[18F] TRACK RADIATION

We propose to use the radiotracer \[18F\] TRACK to non-invasively image the concentration of TrkB/C in the living human brain with PET in the 3 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, and may be of particular importance for the future study of patients with Alzheimer's Disease or mild cognitive impairment. Each participantsubject will receive a single scan with 185 MBq \[18F\] TRACK injected into an antecubital vein. Dynamic PET data will be acquired in list mode for 90 minutes (\[18F\] TRACK) respectively on a CTI/Siemens HRRT PET scanner at the brain imaging center of the Montreal Neurological Institute following our published procedure for \[18F\] TRACK after a transmission scan.

185 MBq [18F] TRACK

Measurement of Arterial Input Function DEVICE

The non-invasive detector, hereinafter called NID, comprises of plastic scintillating fibers (BCF-12, St-Gobain, France) wrapped in a medical-grade acrylic heat-shrink tube (Vention Medical, USA). The scintillating fibers are coupled to 5 m long transmission fibers to bring the signal out of the PET detector. The fibers will be held in place using a 3D-printed structure composed poly-lactic acid. The NID is designed to measure both positrons and photons escaping the wrist. Post-processing software is used to calculate the arterial input function.

Also known as: Non-Invasive Detector

185 MBq [18F] TRACK

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be considered a healthy control, participants will have a Clinical Dementia Rating (CDR) of 0, Montreal Cognitive Assessment (MoCA) greater than or equal to 26 and Mini-Mental State Exam (MMSE) of 24 or greater, with normal results on the Logical Memory 2 score from the Wechsler Memory Scale-Revise (cut-offs adjusted by education level), and normal scores on the Jessen questions for subjective memory complaints \[21\]. For the arterial catheter insertion, participants must have two viable arteries of the hand/arm. Women of childbearing potential must undergo a urine pregnancy test and may only be included if the urine pregnancy test is negative.

Sponsors & Collaborators

• Thiel, Alexander, M.D.: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• University of Alberta: collaborator

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDIV
• Responsible Party: SPONSOR

Model Details: We will study a total of 30 participants, 10 in each of 3 age cohorts 18-29, 30-59 and 60-89, with equal numbers of male and female participants in each cohort.

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: June 22, 2022
• Study Start: August 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: August 1, 2024
• Last Updated: July 21, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share