Discovering biomarkers for early diagnosis of Alzheimer's and Parkinson's diseases
Network-based biOmarker Discovery of Neurodegenerative Diseases Using Multimodal Connectivity
This study is testing if simple and affordable brain scans can help find early signs of Alzheimer's and Parkinson's diseases in people with mild cognitive issues or newly diagnosed Parkinson's.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 1 site (Rennes) |
| Trial ID | NCT06080659 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify low-cost, non-invasive biomarkers for early-stage Alzheimer's and Parkinson's diseases by analyzing the multimodal connectome. Participants, including patients with mild cognitive impairment and newly diagnosed Parkinson's disease, will undergo clinical assessments and MRI scans to evaluate brain connectivity. The study seeks to improve diagnostic accuracy and facilitate early intervention, which is crucial for managing these neurodegenerative conditions effectively.
Who should consider this trial
Good fit: Ideal candidates include French-speaking, right-handed individuals with early-stage Alzheimer's or Parkinson's disease, as well as healthy control volunteers.
Not a fit: Patients with significant medical or psychiatric conditions that could interfere with cognition will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate diagnoses of Alzheimer's and Parkinson's diseases, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using neuroimaging and connectome analysis for biomarker discovery, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Rennes
- CHU Rennes — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Pierre-Yves JONIN, PhD — Rennes University Hospital
- Study coordinator: marie-laure gervais, Phd
- Email: marie-laure.gervais@chu-rennes.fr
- Phone: 299282555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.