ClinicalTrials.gov record NCT06155942

Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes: Analysis in Very High Field (7T) Brain MRI.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.The registry record was last updated on Dec 5, 2023, about 2 years ago, so the status shown may be out of date. The study team or the registry can confirm.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.
Age40 years old to 80 years old
SexAll
LocationFrance
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A diagnostic study comparing very high-field (7T) brain MRI and questionnaires in people with early-stage Parkinson disease, people with early-stage progressive supranuclear palsy, and healthy volunteers. Participants will undergo 7T MRI imaging and complete questionnaires; imaging and clinical measures are compared to look for differences. The study seeks imaging markers that might help distinguish PD from PSP at an early stage.

What it is studying. The study tests whether measures from very high-field (7T) MRI—including intracerebral sodium, iron content, neuromelanin signal, brain volume/atrophy, and structural connectivity—differ between early-stage Parkinson disease and early-stage progressive supranuclear palsy, and how these imaging measures relate to clinical assessments and questionnaires.

What the researchers hope to learn. To identify and compare imaging biomarkers (sodium accumulation, iron, neuromelanin, brain atrophy, water diffusion and connectivity) between Parkinson disease and progressive supranuclear palsy; and to explore relationships between those imaging measures and clinical features (age, sex, disease duration, smell, cognition, motor severity, quality of life, mood, sleep, and other questionnaire-based measures).

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

Parkinson's disease (PD) is the most common degenerative Parkinson's syndrome and is linked, among other things, to the excessive accumulation of an abnormally aggregating protein, alpha-synuclein. Progressive Supranuclear Palsy (PSP) is another Parkinson's syndrome, linked, among other things, to the abnormal accumulation of the protein Tau, and expressed clinically by falls, early cognitive impairment and oculomotor disorders, not present in PD. The onset of these disorders is so gradual that differential diagnosis between the two diseases is only possible at a late stage, on average 3 to 5 years after the onset of symptoms. To date, there is a lack of validated imaging biomarkers for diagnosing and monitoring PD and PSP. There is therefore an urgent need for the development of robust biomarkers capable of detecting neurodegeneration at an early stage, in order to aid differential diagnosis as soon as symptoms appear, and to potentially enable these patients to be included in specific therapeutic trials (as these diseases are pathophysiologically different) with potential neuroprotective effects. The development of cutting-edge technologies such as 7T MRI, combined with optimized image processing methods, now enable non-invasive in vivo exploration and analysis of these small structures in terms of ion homeostasis (sodium), microstructure (volumetry, amount of iron and neuromelanin) and connectivity.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Procedure
  • 7 Tesla MRI

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • For Parkinson Disease:
  • Patients aged between 40 and 80
  • Fulfilling the diagnostic criteria for MPI (Postuma et al., 2015)
  • First motor symptom (rigidity, akinesia, tremor) less than 36 months ago
  • Patient entitled to or affiliated with a social security scheme
  • Patients who understood, completed and signed the consent form for study participation.

Exclusion criteria

  • Patient with a neurological disease of the central nervous system other than those studied (including history of stroke, repeated head trauma, documented encephalitis). In case of doubt, this criterion will be left to the discretion of the principal investigator, who is a neurologist.
  • Contraindications to 7T MRI: presence of an ocular metallic foreign body (accidental shrapnel or other), pacemaker (cardiac simulator) or neurostimulator (pain treatment), cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, vascular clips implanted on a cranial aneurysm.
  • Claustrophobia or any other condition preventing full MRI.
  • Montreal Cognitive Assessment (MOCA) test < 25/30
  • Pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).
  • For Progressive Supra-nuclear Palsy:
  • Patients aged 40 to 80
  • Fulfilling the diagnostic criteria for soPSP (Höglinger et al., 2017) :
  • First motor symptom (rigidity, akinesia, tremor) or falls or cognitive impairment (frontal syndrome or language disorder or cortico-basal syndrome) occurring less than 36 months ago
  • Patients benefiting from or affiliated to a social security scheme
  • Patients who have understood, completed and signed the study participation consent form
  • Patient with a neurological disease of the central nervous system other than those studied (including history of stroke, repeated head trauma, documented encephalitis). In case of doubt, this criterion will be left to the discretion of the principal investigator, who is a neurologist.
  • Contraindications to 7T MRI: presence of an ocular metallic foreign body (accidental shrapnel or other), pacemaker (cardiac simulator) or neurostimulator (pain treatment), cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, vascular clips implanted on a cranial aneurysm.
  • Claustrophobia or any other condition preventing MRI.
  • Pregnant or breast-feeding woman or protected person (under guardianship, curatorship, deprived of liberty).
  • For Control group:
  • Subjects aged between 40 and 80
  • Subjects benefiting from or affiliated with a social security plan
  • Subjects who have understood, completed and signed the study participation consent form
  • Subjects with a known history of neurological disease of the central nervous system (e.g. Parkinson's disease, Alzheimer's, stroke, brain tumor, multiple sclerosis, amyotrophic lateral sclerosis, repeated head trauma, documented encephalitis, etc.). In case of doubt, this criterion will be left to the discretion of the principal investigator, who is a neurologist.
  • Contraindications to 7T MRI: presence of an ocular metallic foreign body (accidental shrapnel or other), pacemaker (cardiac simulator) or neurostimulator (pain treatment), cochlear implants or any implanted electronic medical equipment in general, metallic heart valve, vascular clips implanted on a cranial aneurysm.
  • Claustrophobia or any other condition preventing MRI.
  • Pregnant or breast-feeding women or protected persons (under guardianship, curatorship, deprived of liberty).

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will undergo a very‑high‑field (7 Tesla) brain MRI and complete questionnaires and clinical scales (the registry lists measures such as the Montreal Cognitive Assessment, UPDRS, PDQ‑39, smell, sleep, mood and other questionnaires). The same procedures apply to the Parkinson, PSP and healthy volunteer groups. Measurements and assessments are planned between enrollment (month 0) and up to month 3 after inclusion. The study excludes people with MRI contraindications or who cannot tolerate an MRI (for example due to claustrophobia).

How the study is structured. Interventional diagnostic study with three non-randomized parallel groups (PD, PSP, healthy volunteers). Participants receive 7T MRI scans and complete questionnaires; imaging and clinical data are analyzed and compared across groups. There is no masking (open-label). Measurements are taken between inclusion and up to three months afterwards, as described in the registry.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry says recruitment has not started. When is it expected to open, and can I register interest now?
  • The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on progressive supranuclear palsy

Clinical trials45 trials listed for progressive supranuclear palsyEvery trial the registry lists for progressive supranuclear palsy, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in progressive supranuclear palsy researchLatest monthly update: September 2026. Includes: PSP vs Parkinsons. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start
Jan 15, 2024 (estimated)
Primary completion
Jan 15, 2026 (estimated)
Study completion
Jan 15, 2028 (estimated)
Target enrollment
63 participants (estimated)
Last updated on registry
Dec 5, 2023
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Assistance Publique Hopitaux De Marseille

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (6)

  • Ch Pays D'Aix

    Aix-en-Provence, 13080 · France

  • Hôpital Privé La Casamance - Service de Neurologie

    Aubagne, 13400 · France

  • Centre Hospitalier Avignon - Service de Neurologie

    Avignon, 84000 · France

  • CENTRE HOSPITALIER UNIVERSITAIRE NICE - Service de Neurologie

    Nice, 06000 · France

  • CENTRE HOSPITALIER NIMES - Service de Neurologie

    Nîmes, 30000 · France

  • CENTRE HOSPITALIER SAINTE MUSSE - Toulon

    Toulon, 83000 · France

Terms used on this page · explanations by MedicalUpdates.ai

biomarkers
Something measurable in the body, such as a blood test result or an imaging finding, that indicates how a condition or treatment is behaving.
MRI
A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
principal investigator
The doctor or scientist responsible for running the study at a site or overall.
Contraindications
A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
Control group
The group the study treatment is compared with. It may receive a placebo, an existing treatment (active comparator), a sham procedure, or no intervention.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

← Back to clinical trials