Synaptic Loss in Multiple System Atrophy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age45-80
SponsorUniversity of Exeter
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Combined (estrogen and progesterone containing) hormonal contraception associated with initiation of ovulation( oral, intravaginal, or transdermal);
Progesterone-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable);
Intrauterine device;
Intrauterine hormone releasing system;
Disqualifiers
Any spinal malformation or other aspects (e.g. tattoos) / clinical findings (e.g. papilledema) that may complicate or contraindicate lumbar puncture, as judged by the investigator.
Neoplasm or other space-occupying intracranial lesion on MRI. Any clinically important abnormality, as determined by the investigator, on physical examination or vital signs, ECG, or clinical laboratory test results other than abnormality due to a stable, well-controlled medical condition; or any abnormality that could be detrimental to the subject or could compromise the study.
Trial population
Patients with a diagnosis of MSA; patients with a diagnosis of PSP
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Study procedures for MSA patients
Other interventionThe 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.
Study procedures for PSP patients
Other interventionThe 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.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Patients with MSA1 intervention
Group B: Patients with Progressive Supranuclear Palsy1 intervention
Trial outcomes
Primary outcomes
1
To measure the magnitude of longitudinal within-group change in [11C]UCB-J volume of distribution in MSA
\[11C\]UCB-J is a marker of synaptic damage in MSA
Time frame
Baseline to 12 MonthsSecondary outcomes
1
Progression of brain glucose metabolism in MSA
Brain glucose metabolism is assessed with serial \[18F\]FDG PET scans at baseline and after 12-month follow-up.
Time frame
Baseline to 12 Months2
To investigate differences in MRI structural, microstructural, molecular, and functional parameters in MSA patients.
Magnetic Resonance Imaging change in Magnetization Prepared Rapid Acquisition Gradient Echo \[MPRAGE\]
Time frame
Baseline to 12 Months3
To investigate differences in structural MRI parameters in MSA patients.
Magnetic Resonance Imaging change in Magnetization Prepared Rapid Acquisition Gradient Echo \[MPRAGE\]
Time frame
Baseline to 12 Months4
To investigate differences in iron-sensitive MRI in MSA patients.
Magnetic Resonance Imaging change in Susceptibility Weighted Imaging \[SWI\]
Time frame
Baseline to 12 MonthsSponsors and contacts
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Source ClinicalTrials.gov