NCT05121012

Synaptic Loss in Multiple System Atrophy

Molecular Imaging of Synaptic Loss in Multiple System Atrophy (MSA)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 36 (estimated)
• Sponsor: University of Exeter · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

In this study the investigators would like to investigate the degree of damage of the synapses, an important part of the neurons vital for the communications between neurons, in Multiple System Atrophy (MSA), and pathology related to abnormal accumulation of a protein named tau, in Progressive Supranuclear Palsy (PSP).

Detailed description

Multiple System Atrophy (MSA) is a chronic and progressive neurological disease, for which unfortunately there is no cure yet. It is known from pathological studies that the synapses (the terminal parts of the neurons) are affected in this disease, but the investigators don't know how, and how much this happens. An imaging tool called Positron Emission Tomography (PET) can study the integrity of the synapses by the use of a dedicated tracer, called \[11C\]UCB-J. In this study the investigators would like to study how, and how early, the synapse deteriorate in patients with MSA. For this study, patients with the MSA will be enrolled. Participants will be asked to undergo a clinical visit with questionnaires and scales for motor and cognitive symptoms. Then, participants will come for a \[11C\]UCB-J PET scan, a \[18F\]FDG PET scan, to check the metabolism of the brain, and a MRI scan, to help the analysis of the PET. The participants will also be asked to perform a Lumbar puncture for a cerebrospinal fluid draw. This procedure will be optional. A subgroup of up to 10 patients with MSA who took part to the main study will also undergo an imaging substudy, with a PET scan (only at a single timepoint) with the tracer \[18F\]APN107. \[18F\]APN107 is a novel tracer measuring a protein in the brain named tau. Tau abnormally accumulates in patients with a disease named Progressive Supranuclear Palsy (PSP) but not in MSA. It is sometimes very challenging to distinguish MSA and PSP on the basis of the clinical observation. We hope that a PET scan with \[18F\]APN107 could help distinguish these disorders more. This subgroup of patients with MSA will be compared with a group of up to 16 patients with PSP (the clinical forms named PSP-RS and PSP-P) who will undergo the following activities: At baseline, a clinical visit with administration of pen-and-paper tests and scales,, a venous blood collection, an MRI scan and one \[18F\]APN107 PET scan; After approximately one year from baseline (follow-up), the repetition of the same activities as at baseline. The results will help in understanding better the mechanisms underlying thiese two conditions and open new avenues for its treatment.

Conditions

• Multiple System Atrophy
• Progressive Supranuclear Palsy (PSP)

Interventions

Type	Name	Description
OTHER	Study procedures for MSA patients	The group of MSA patients will undergo a collection of demographic data, a neurological examination with administration of clinical scales relevant for MSA, and a collection of venous blood sample for routine and biomarker analyses. Participants will undergo one PET scan with the tracer \[11C\]UCB-J, and one PET scan with the tracer \[18F\]FDG. All participants will also undergo one MRI scan. Participants will also undergo one lumbar puncture (optional). All procedures will be performed at baseline and after one-year follow-up. A subgroup of patients with MSA will also undergo, at one time point only, one PET scan with the tracer \[18F\]APN107.
OTHER	Study procedures for PSP patients	The group of PSP patients will undergo a collection of demographic data, a neurological examination with administration of clinical scales relevant for PSP, and a collection of venous blood sample for routine and biomarker analyses. Participants will undergo one PET scan with the tracer \[18F\]APN107 and one MRI scan. All procedures will be performed at baseline and after one-year follow-up.

Timeline

• Start date: 2021-09-01
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2021-11-16
• Last updated: 2026-02-10

Locations

1 site across 1 country: United Kingdom