NCT05880563

Investigation of Cannabinoid 2-receptor Expression in the Brain and Spine of ALS-patients Compared to Healthy Controls With PET (18F-RoSMALS)

A Monocentric, Controlled, Open Label, Phase I, First-in-human Trial to Investigate the Regional Distribution of [18F]RoSMA-18-d6 in the Brain and Spinal Cord to Assess Cannabinoid Type 2 Receptor (CB2R) Expression in Healthy Volunteers and Patients With Amyotrophic Lateral Sclerosis (ALS) by Positron Emission Tomography (PET)

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Markus Weber · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical trial is a phase 1 study in which investigations with the weakly radioactive substance \[18F\]-RoSMA-18-d6 are being carried out for the first time. This radiolabeled substance will be used to study a specific protein in the brain and spinal cord of patients with ALS and healthy individuals. This particular protein, the cannabinoid type 2 receptor, is thought to play a role in the disease process of ALS. Furthermore, it is assumed that this protein is found more frequently in the brain and spinal cord of patients with ALS compared to healthy individuals. The following questions will be answered by this clinical trial. 1. Is this protein found, as suspected, increased in the brain and spinal cord of ALS patients compared to healthy individuals ? 2. Does the amount of this protein change during the course of the disease? 3. Are there any correlations between the observed changes in the amount of protein and the assessment of the course of the disease?

Conditions

• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DRUG	[18F]-RoSMA-18-d6	\[18F\]-RoSMA-18-d6 will be administered intravenously by a bolus injection followed by a subsequent PET/CT-scan of the brain and the spine

Timeline

• Start date: 2023-08-01
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-05-30
• Last updated: 2023-05-30

Locations

1 site across 1 country: Switzerland