Actively Recruiting

Age: 45Years - 80Years
All Genders
NCT05121012

Synaptic Loss in Multiple System Atrophy

Led by University of Exeter · Updated on 2026-02-10

36

Participants Needed

1

Research Sites

291 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

Synaptic Loss in Multiple System Atrophy

Who Can Participate

Age: 45Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female, aged 45 to 80 years at the time of informed consent
  • Meet diagnostic criteria for probable or possible Multiple System Atrophy (MSA) or for suggestive, probable, or possible Progressive Supranuclear Palsy (PSP)
  • Females of childbearing potential must not be pregnant or lactating and must agree to use specified contraception methods
  • Male participants with female partners of childbearing potential must use contraception or abstain from sexual activity for 90 days after each radiotracer dose
  • Able to understand the study and provide written informed consent
  • Willing and able to participate in all scheduled evaluations and procedures
  • Anticipated survival of at least 3 years as judged by the investigator
  • Medical treatment and co-morbid conditions must be stable for at least 30 days prior to screening and between screening and baseline PET scan
  • Willing to comply with study protocol and complete the study
  • For optional cerebrospinal fluid sampling, separate informed consent is required
Not Eligible

You will not qualify if you...

  • History of other neurological disorders or intracranial conditions such as stroke, hemorrhage, or space-occupying lesions
  • Presence of supranuclear gaze palsy (for MSA group)
  • Clinically significant unstable medical conditions that could affect safety or study completion
  • Severe dependence on caregivers, severe swallowing impairment, or frequent falls (for MSA group)
  • Contraindications to MRI including implanted devices like pacemaker, cardiac defibrillator, aneurysm clip, artificial heart valve, or metal fragments
  • Negative modified Allen test in both hands
  • History of claustrophobia or back pain making MRI or PET scanning intolerable
  • Pregnancy, lactation, or positive pregnancy test at screening or before PET scan
  • Use of drugs acting on SV2A such as certain antiepileptics
  • History of brain surgery for parkinsonism or stem cell treatment
  • Clinically significant blood clotting or bleeding disorders
  • Current or recent alcohol or drug abuse or dependence (except nicotine)
  • History of cancer within the last 5 years except nonmetastatic basal cell carcinoma
  • Hemoglobin A1c ≥ 6.5% indicating uncontrolled diabetes
  • For optional lumbar puncture: spinal malformations, tattoos, papilledema, or other conditions complicating the procedure
  • Any clinically important abnormality found on physical exam, vital signs, ECG, or lab tests that could be detrimental or affect the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of Exeter

Exeter, United Kingdom, SE16 7RJ

Actively Recruiting

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Research Team

E

Edoardo R. de Natale, MD MSc Ph.D

CONTACT

H

Heather Wilson, MSc Ph.D

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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