Network-based biOmarker Discovery of Neurodegenerative Diseases Using Multimodal Connectivity
NCT ID: NCT06080659
Last Updated: 2026-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
120 participants
INTERVENTIONAL
2023-11-06
2026-12-31
Brief Summary
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Detailed Description
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Current criteria, which are essentially clinical, have a relatively low diagnostic accuracy, which is unfortunately responsible for a delay in diagnosis, whereas it has been established that early diagnosis makes it possible to postpone the loss of autonomy, open up opportunities for clinical trials for patients, and, epidemiologically speaking, ultimately reduce the prevalence of major neurocognitive disorders.
Recent advances in neuroimaging techniques and connectome analysis have led to the identification of innovative biomarkers that reflect the disorganization of brain networks and are associated with clinical symptoms.
After participant inclusion, the experimental visit will take place over half a day, for patients with early-stage Alzheimer's or Parkinson's disease and for healthy control volunteers.
After clinical assessment, participants will undergo an MRI scan and then perform the CONFMEM experimental task.
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).
The cerebral connectome will be assessed for each patient, with the aim of determining whether patterns can lead to pathology-specific markers.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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DCS+
Patient with subjective cognitive decline, prodromal condition of Alzheimer's disease
fMRI
functional MRI
CONFMEM
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).
TCL-MA
Patient with mild neurocognitive disorder linked to Alzheimer's disease
fMRI
functional MRI
CONFMEM
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).
MPdn
early-stage or de novo Parkinson's disease patients with no cognitive deficits
fMRI
functional MRI
CONFMEM
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).
TCL-MP
Patient with mild neurocognitive disorder linked to Parkinson's disease
fMRI
functional MRI
CONFMEM
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).
Healthy volunteers
Healthy volunteers
fMRI
functional MRI
CONFMEM
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).
Interventions
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fMRI
functional MRI
CONFMEM
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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
50 Years
80 Years
ALL
Yes
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Pierre-Yves JONIN, PhD
Role: PRINCIPAL_INVESTIGATOR
CHU Rennes
Locations
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CHU Rennes
Rennes, , France
Countries
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Central Contacts
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Facility Contacts
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Pierre-Yves JONIN
Role: primary
Other Identifiers
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35RC22_9712_NODAL
Identifier Type: -
Identifier Source: org_study_id
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