Network-based BiOmarker Discovery of Neurodegenerative Diseases Using Multimodal Connectivity

Launched by RENNES UNIVERSITY HOSPITAL · Oct 5, 2023

Keywords

ClinConnect Summary

The NODAL clinical trial is exploring new ways to detect early signs of neurodegenerative diseases like Alzheimer's and Parkinson's. Researchers are focusing on identifying low-cost and non-invasive biomarkers, which are indicators that can help understand these diseases better and potentially lead to earlier diagnosis. The study is currently recruiting participants aged between 18 and 29 years who are French speakers and right-handed, with at least a primary school education. To be included, participants should be free of serious medical or psychiatric conditions that could affect their thinking, and they must agree to participate after receiving detailed information about the trial.

Participants in this study will undergo various assessments to help researchers understand the brain's connectivity and how it may relate to these diseases. People diagnosed with mild cognitive impairment related to Alzheimer's or newly diagnosed Parkinson's disease, as well as those experiencing mild cognitive issues related to Parkinson's, are particularly encouraged to join. It’s important to note that individuals with certain medical devices or conditions, like those who are pregnant or have severe anxiety about MRI machines, may not be eligible. Overall, this trial aims to contribute to better understanding and early detection of these serious conditions, which could lead to improved care for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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 Criteria:
• • 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)