Status:
RECRUITING
Network-based biOmarker Discovery of Neurodegenerative Diseases Using Multimodal Connectivity
Lead Sponsor:
Rennes University Hospital
Conditions:
Alzheimer Disease, Early Onset
Parkinson Disease
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
The aim of the NODAL clinical trial is to demonstrate the feasibility of new, low-cost, non-invasive biomarkers of neurodegenerative pathologies as early Alzheimer and Parkinson, based on the estimati...
Detailed Description
Alzheimer's (AD) and Parkinson's (PD) diseases are characterized by pre-clinical and asymptomatic phases, which can extend over decades, before progressing through different clinical stages where cogn...
Eligibility Criteria
Inclusion
- For all participants:
- French mother tongue
- right-handed
- with a level of education equal to or higher than the Certificat d'Études Primaires (Primary School Certificate)
- Free of any medical or psychiatric condition likely to interfere with cognition (excluding diagnosis for patients)
- Affiliated with a social security scheme
- Having received oral and written information about the protocol and having signed a consent form to participate in this research.
- DCS+ group:
- \- Meeting the diagnostic criteria for "subjective cognitive decline-plus" (Jessen criteria (Jessen et al., 2014).
- Alzheimer's patients "Mild Cognitive Impairment due to Alzheimer's Disease," "MCI-MA":
- \- Meeting the diagnostic criteria for "Mild neurocognitive disorder due to Alzheimer's disease" (criteria of (Albert et al., 2011))
- De novo" Parkinsonian patients, "MPdn":
- \- Presenting with newly diagnosed ("de novo") Parkinson's disease and free of cognitive deficits (criteria of Postuma et al., 2015 (Postuma et al., 2015))
- Parkinsonian patients with "Mild Cognitive Impairment, "MCI-MP":
- \- Presenting Parkinson's disease associated with "mild neurocognitive impairment" (criteria of Litvan et al., 2012 (Litvan et al., 2012))
Exclusion
- All participants (healthy volunteers and patients)
- Contraindications to MRI :
- Abdominal circumference + upper limbs sticking to the body \> 200 cm;
- Implantable pacemaker or defibrillator;
- Neurosurgical clips;
- Cochlear implants ;
- Neural or peripheral stimulator;
- Intra-orbital or encephalic metallic foreign bodies;
- Endoprostheses fitted less than 4 weeks ago and osteosynthesis devices fitted less than 6 weeks ago;
- Claustrophobia.
- Pregnant or breast-feeding women;
- Adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
- Patients only
- Score \>2 on the modified Hachinski scale (Hachinski et al., 2012)
- Dementia according to McKhann criteria (McKhann et al., 2011)
- Sensory deficit interfering with experimental tests
- Healthy volunteers only
- \- Cognitive impairment (MoCA score \< 26)
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06080659
Start Date
November 6 2023
End Date
December 1 2026
Last Update
January 5 2026
Active Locations (1)
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1
CHU Rennes
Rennes, France