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

NCT05880563 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-05-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • ETH Zurich

    collaborator OTHER
  • Insel Gruppe AG, University Hospital Bern

    collaborator OTHER
  • Markus Weber

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-31
Primary Completion
2026-09-30
Completion
2026-09-30

Countries

  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05880563 on ClinicalTrials.gov