Investigation of Cannabinoid 2-receptor Expression in the Brain and Spine of ALS-patients Compare… (NCT05880563) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Investigation of Cannabinoid 2-receptor Expression in the Brain and Spine of ALS-patients Compared to Healthy Controls With PET (18F-RoSMALS)
Switzerland30 participantsStarted 2023-08
Plain-language 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?
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria \_ALS-patients:
* Age ≥18 years
* Able to provide written informed consent prior to study participation
* Body weight of ≥ 50 kg and a body mass index (BMI) between 19-30 kg/m2
* Vital signs measured after three minutes resting in the supine position must be within the following ranges:
* oral body temperature: 35.0-37.5 °C
* systolic blood pressure: 90-140 mm Hg
* diastolic blood pressure: 50-90 mm Hg
* pulse rate: 40-90 bpm
* Clinically probable, probable laboratory supported, or definite ALS-diagnosis according to the revised version of the El Escorial World Federation of Neurology criteria (EEC) (46)
* Disease duration ≤ 18 months since date of diagnosis
* Slow vital capacity (sVC) ≥ 80 % of normal (best of three measurements)
* Pre-study ALSFRS-R progression between disease onset and screening of -0.4 points/month or worse (calculated by ALSFRS-R score decline from 48 divided by months since symptom onset until screening)
* Patient has to be on a stable dose of disease modifying treatments (Edaravone 60 mg i.v.
on ten days/month, Riluzole 100 mg/day)
nclusion Criteria \_Healthy controls
* Age ≥ 18 years
* Able to provide written informed consent prior to study participation
* Body weight of ≥ 50 kg and a body mass index (BMI) between 19-30 kg/m2
* Vital signs measured after 3 minutes resting in the supine position must be within the following ranges:
* oral body temperature: 35.0-37.5 °C
* systolic blood pressure: 90-140 mm Hg
* dia…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference of [18F]RoSMA-18-d6 uptake in the brain and spinal cord between ALS patients (at baseline and day 360) and healthy, age- and gender-matched subjects, as assessed by PET and MRI to allow morphological mapping