Network-based biOmarker Discovery of Neurodegenerative Diseases Using Multimodal Connectivity

NCT06080659 | Recruiting

• 1 other identifier: 35RC22_9712_NODAL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 estimation of the multimodal connectome.

Conditions

Alzheimer Disease, Early Onset; Parkinson Disease

Keywords

connectome

Outcome Measures

Primary Outcomes (1)

• Multimodal connectivity graph metrics across diseases

  Multi-layer graph combining the functional and structural connectivity will provide an ideal framework for identifying multimodal features. The first layer corresponds to the functional connectivity where links represent the similarity between the fMRI signal from different cerebral regions (i.e. the nodes), using the cross-correlation. The second layer represents the structural connectivity where the edges are the fiber density between the nodes. Topological metrics of graph: 1/ the nodal centrality which quantifies how important a node is within a network, 2/ the betweenness defined as the ratio of the number of the shortest paths comprising the node to the total number of shortest paths in the graph, measures the hub property of the node and 3/ local efficiency which quantify the ability of a network to transmit information at the global and local level, will be compared between patients at-risk for Alzheimer's Disease, patients with Parkinson's Disease and healthy controls.

  2 hours and 30 minutes

Secondary Outcomes (2)

• Multimodal connectivity graph metrics across stages of disease

  2 hours and 30 minutes

• Correlation between multimodal connectivity graph metrics and cognitive scores

  Up to 6 months (maximum delay between the study visit and the collection of standard tasks).

Study Arms (5)

DCS+

EXPERIMENTAL

Patient with subjective cognitive decline, prodromal condition of Alzheimer's disease

Diagnostic Test: fMRI; Diagnostic Test: CONFMEM

TCL-MA

EXPERIMENTAL

Patient with mild neurocognitive disorder linked to Alzheimer's disease

Diagnostic Test: fMRI; Diagnostic Test: CONFMEM

MPdn

EXPERIMENTAL

early-stage or de novo Parkinson's disease patients with no cognitive deficits

Diagnostic Test: fMRI; Diagnostic Test: CONFMEM

TCL-MP

EXPERIMENTAL

Patient with mild neurocognitive disorder linked to Parkinson's disease

Diagnostic Test: fMRI; Diagnostic Test: CONFMEM

Healthy volunteers

ACTIVE COMPARATOR

Healthy volunteers

Diagnostic Test: fMRI; Diagnostic Test: CONFMEM

Interventions

fMRI DIAGNOSTIC_TEST

functional MRI

DCS+; Healthy volunteers; MPdn; TCL-MA; TCL-MP

CONFMEM DIAGNOSTIC_TEST

The aim of this paradigm is to identify the impact of cognitive conflict situations on recognition memory (the ability to judge whether or not a stimulus has been previously presented).

DCS+; Healthy volunteers; MPdn; TCL-MA; TCL-MP

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Parkinson Disease

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pierre-Yves JONIN, PhD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

marie-laure gervais, Phd

CONTACT

299282555; marie-laure.gervais@chu-rennes.fr

Pierre-Yves JONIN, PhD

CONTACT

299284321; pierreyves.jonin@chu-rennes.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: September 22, 2023
• First Posted: October 12, 2023
• Study Start: November 6, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Locations

FR (1)