Alzheimer Disease, Early OnsetNODALNCT06080659
Network-based biOmarker Discovery of Neurodegenerative Diseases Using Multimodal Connectivity
A study testing fMRI and CONFMEM in people with Alzheimer Disease, Early Onset and Parkinson Disease, run by Rennes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Early Onset, Parkinson Disease
- What is being tested?
- fMRI and CONFMEM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2023to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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))
Who cannot join
- 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 ;
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Rennes
Rennes
Pierre-Yves JONIN
Pierre-Yves JONIN, PhD
About this study
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.
Read the 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 cognitive and/or motor symptoms appear. A major challenge for clinical neuroscience is the availability of reliable, non-invasive and inexpensive biomarkers to enable early diagnosis, be clinically relevant, and ideally contribute to prognosis and patient monitoring.
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
- Alzheimer Disease, Early Onset, Parkinson Disease
- Being tested
- fMRI, CONFMEM
- Keywords
- connectome
- Medical subject headings
- Alzheimer Disease, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIDiagnostic test
functional MRI
CONFMEMDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| DCS+ | Experimental | Patient with subjective cognitive decline, prodromal condition of Alzheimer's disease Receives: Diagnostic Test: fMRI; Diagnostic Test: CONFMEM |
| TCL-MA | Experimental | Patient with mild neurocognitive disorder linked to Alzheimer's disease Receives: Diagnostic Test: fMRI; Diagnostic Test: CONFMEM |
| MPdn | Experimental | early-stage or de novo Parkinson's disease patients with no cognitive deficits Receives: Diagnostic Test: fMRI; Diagnostic Test: CONFMEM |
| TCL-MP | Experimental | Patient with mild neurocognitive disorder linked to Parkinson's disease Receives: Diagnostic Test: fMRI; Diagnostic Test: CONFMEM |
| Healthy volunteers | Active comparator | Healthy volunteers Receives: Diagnostic Test: fMRI; Diagnostic Test: CONFMEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours and 30 minutes
Secondary outcomes (2)
Multimodal connectivity graph metrics across stages of disease
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 correlation between the fMRI signal. 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 and 3/ local efficiency which quantify the ability of a network to transmit information, will be compared between patients at-risk for Alzheimer's Disease at the Subjective Cognitive Decline stage and at the Mild Cognitive Impairment stage. Similarly, patients with Parkinson's Disease without cognitive impairment and with Parkinson's Disease with Mild Cognitive will be compared.
Measured: 2 hours and 30 minutes
Correlation between multimodal connectivity graph metrics and cognitive scores
Cognitive scores will include standard tasks (MOCA, Symbol Digit Modality Test - oral, Digit span, 16-items Free \& Cued Selective Reminding Test, 10/36 spatial recall test, Oral Letter-Number Sequencing test, D-KEFS Color-Word Interference Test, Benton Judgment of Line Orientation, CLOX clock-drawing test, Boston Naming Test, Animal fluency) and an experimental recognition memory task. As for the latter, the scores used will be the congruency effect during study (RT in milliseconds), global recognition accuracy, and the effect of congruency on subsequent memory (difference in recognition accuracy between congruent and incongruent trials at study).
Measured: Up to 6 months (maximum delay between the study visit and the collection of standard tasks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start6 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves JONIN, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06080659
- Sponsor's protocol ID
- 35RC22_9712_NODAL
- Acronym
- NODAL
- Status last verified
- Dec 2025
- First submitted
- 22 Sep 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network-based biOmarker Discovery of Neurodegenerative Diseases Using Multimodal Connectivity
- ClinicalTrials.gov ID
- NCT06080659
- Acronym / sponsor ID
- NODAL / 35RC22_9712_NODAL
- Conditions
- Alzheimer Disease, Early Onset, Parkinson Disease
- Keywords
- connectome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 6 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 cognitive and/or motor symptoms appear. A major challenge for clinical neuroscience is the availability of reliable, non-invasive and inexpensive biomarkers to enable early diagnosis, be clinically relevant, and ideally contribute to prognosis and patient monitoring.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| DCS+ | Experimental | Diagnostic Test: fMRI, Diagnostic Test: CONFMEMPatient with subjective cognitive decline, prodromal condition of Alzheimer's disease |
| TCL-MA | Experimental | Diagnostic Test: fMRI, Diagnostic Test: CONFMEMPatient with mild neurocognitive disorder linked to Alzheimer's disease |
| MPdn | Experimental | Diagnostic Test: fMRI, Diagnostic Test: CONFMEMearly-stage or de novo Parkinson's disease patients with no cognitive deficits |
| TCL-MP | Experimental | Diagnostic Test: fMRI, Diagnostic Test: CONFMEMPatient with mild neurocognitive disorder linked to Parkinson's disease |
| Healthy volunteers | Active comparator | Diagnostic Test: fMRI, Diagnostic Test: CONFMEMHealthy volunteers |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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)
Key exclusion criteria (18 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIfunctional MRI | Diagnostic test | DCS+, Healthy volunteers, MPdn, TCL-MA, TCL-MP |
| CONFMEMThe 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). | Diagnostic test | DCS+, Healthy volunteers, MPdn, TCL-MA, TCL-MP |
Primary outcome
Multimodal connectivity graph metrics across diseases
Time frame: 2 hours and 30 minutes
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 secondary outcomes
Multimodal connectivity graph metrics across stages of disease
Time frame: 2 hours and 30 minutes
Correlation between multimodal connectivity graph metrics and cognitive scores
Time frame: Up to 6 months (maximum delay between the study visit and the collection of standard tasks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre-Yves JONIN, PhD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI and CONFMEM in people with Alzheimer Disease, Early Onset and Parkinson Disease, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact marie-laure gervais, Phd (299282555 ext. +33, marie-laure.gervais@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multimodal connectivity graph metrics across diseases (time frame: 2 hours and 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.