mGluR5 Imaging in ALS Using PET

NCT05340660 | Unknown

• 1 other identifier: BASEC Nr. 2021-01044
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In ALS models, it was shown that receptors, that bind an important messenger substance (glutamate) in the brain, are increased. In this research project, the investigators want to use a specific radioactive substance to find out whether these receptors are more detectable in people with ALS than in healthy people and increase over the course of the disease.

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Receptor, Metabotropic Glutamate 5; Brain / diagnostic imaging; Positron-Emission Tomography / methods; Radiopharmaceuticals / pharmacokinetics*; PSS232; Humans; Adult

Outcome Measures

Primary Outcomes (1)

• Change from baseline in [18F]PSS232 uptake in the brain and spinal cord in ALS patients at 6 months

  Difference of \[18F\]PSS232 uptake in the brain and spinal cord of ALS patients at baseline and day 180, as assessed by PET and MRI to allow morphological mapping.

  Baseline and 6 months

Secondary Outcomes (4)

• Difference of [18F]PSS232 uptake in the brain and spinal cord between ALS patients and healthy, age and gender-matched subjects.

  6 months

• Correlation of change from baseline of [18F]PSS232 uptake with change from baseline of ALSFRS-R Score at day 180

  6 months

• Correlation of change from baseline of [18F]PSS232 uptake with change from baseline of respiratory function, as measuerd by slow vital capacity (sVC) and sniff nasal inspiratory pressure (SNIP) at day 180

  6 months

• Correlation of change from baseline of [18F]PSS232 uptake with change from baseline of ECAS at day 180

  6 months

Study Arms (1)

ALS Patient

EXPERIMENTAL

Radiation: [ 18 F]PSS232

Interventions

[ 18 F]PSS232 RADIATION

\[ 18 F\]PSS232 for imaging metabotropic glutamate receptor subtype 5 and comparing expression of the receptor in healthy persons and ALS patients

ALS Patient

Eligibility Criteria

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

You may qualify if:

• Clinically probable, probable laboratory supported, or definite ALS according to the revised version of the El Escorial World Federation of Neurology criteria (EEC) (45)
• Disease duration ≤18 months
• Pre-study ALSFRS-R progression between disease onset and screening of - 0.4 points/month or worse (calculated by ALSFRS -R total score decline form 48 divided by the months since onset of ALS symptoms)
• Upright slow vital capacity (sVC) ≥65 % of normal (best of three measurements)

You may not qualify if:

• Previous participation in another clinical study involving trial medication within the preceding 12 weeks
• History or presence of significant psychiatric disease, such as depression, evaluated with the ALS depression questionnaire (ADI-12) ≥ 23 (43) since depression has an impact on mGluR5 expression (44)
• Use of tobacco, including cigarettes, smokeless tobacco, cigars, and pipes; Ex- smoker having quit smoking ≥ 2 years

Sponsors & Collaborators

• Nathalie Braun: lead
• University of Zurich: collaborator
• ETH Zurich: collaborator

Study Sites (1)

Neuromuscular Center/ALS Clinic, Cantonal Hospital St. Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Nathalie Braun, MD, PhD

  Neuromuscular Center/ALS Clinic, Cantonal Hospital St. Gallen, 9007 St. Gallen, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Braun, MD, PhD

CONTACT

+41 71 494 35 81; nathalie.braun@kssg.ch

Zylfije Dibrani

CONTACT

+41 71 494 35 81; Zylfije.Dibrani@kssg.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 22, 2022
• Study Start: April 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: April 1, 2025
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

CH (1)