Early Biomarkers of Neurodegeneration in Parkinsonian Syndromes

NCT06155942 | Not Yet Recruiting

• 2 other identifiers: RCAPHM22_0291ID-RCB
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Parkinson Disease; Progressive Supranuclear Palsy

Keywords

MRI; Parkinson disease; progressive supranuclear palsy; biomarkers

Outcome Measures

Primary Outcomes (1)

• Sodium accumulation between Parkinson disease patients and Progressive Supranuclear Palsy

  Comparison of intracerebral sodium accumulation measured by very high-field (7T) cerebral MRI between subjects with Idiopathic Parkinson's Disease and subjects with early-stage Progressive Supra-Nuclear Palsy

  Between month 0 and month 3 after inclusion

Secondary Outcomes (91)

• Sodium accumulation between Parkinson disease patients (MPI) and control subjects

  Between month 0 and month 3 after inclusion

• Sodium accumulation between Progressive Supra-nuclear patients (soPSP) and control subjects

  Between month 0 and month 3 after inclusion

• Brain atrophy between MPI and soPSP patients

  Between month 0 and month 3 after inclusion

• Brain atrophy between MPI and control group

  Between month 0 and month 3 after inclusion

• Brain atrophy between soPSP and control group

  Between month 0 and month 3 after inclusion

Study Arms (3)

Patients with Parkinson Disease

OTHER

Procedure: 7 Tesla MRI

Patients with Progressive Supranuclear Palsy

OTHER

Procedure: 7 Tesla MRI

Healthy volunteers

OTHER

Procedure: 7 Tesla MRI

Interventions

7 Tesla MRI PROCEDURE

Patients will have a 7T MRI and questionnaires

Also known as: Questionnaires

Healthy volunteers; Patients with Parkinson Disease; Patients with Progressive Supranuclear Palsy

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (6)

Ch Pays D'Aix

Aix-en-Provence, 13080, France

Location

Hôpital Privé La Casamance - Service de Neurologie

Aubagne, 13400, France

Location

Centre Hospitalier Avignon - Service de Neurologie

Avignon, 84000, France

Location

CENTRE HOSPITALIER UNIVERSITAIRE NICE - Service de Neurologie

Nice, 06000, France

Location

CENTRE HOSPITALIER NIMES - Service de Neurologie

Nîmes, 30000, France

Location

CENTRE HOSPITALIER SAINTE MUSSE - Toulon

Toulon, 83000, France

Location

MeSH Terms

Conditions

Parkinson Disease; Supranuclear Palsy, Progressive

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Francois Cremieux

  AP-HM

  STUDY DIRECTOR

Central Study Contacts

Stephan Grimaldi, MD

CONTACT

0491385266; stephan.grimaldi@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: December 5, 2023
• Study Start: January 15, 2024
• Primary Completion: January 15, 2026
• Study Completion (Estimated): January 15, 2028
• Last Updated: December 5, 2023

Record last verified: 2023-11

Locations

FR (6)