NCT06099587 MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease
| NCT ID | NCT06099587 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rennes University Hospital |
| Condition | Alzheimer Disease, Early Onset |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2024-07-02 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with Mild Cognitive Impairment (MCI) or Subjective Cognitive Decline (SCD) may or may not develop Alzheimer's disease (AD) dementia. Yet identifying patients at risk is crucial: delaying the onset of the disease by 5 years could reduce prevalence by 50%. To achieve this, we need affordable biomarkers combined with clinically meaningful assessment tools. Current approaches (cognition, imaging or Tau and Amyloid peptide assays) lack precision or specificity (e.g., age-related memory deficits) and involve invasive and costly procedures, sometimes inaccessible in France (e.g., the "AT(N)" framework). Recently, quantitative diffusion MRI (dMRI) has identified in-vivo gray matter microstructural changes linked to hyperphosphorylated Tau protein, which are of great diagnostic value. Still, we ignore whether and how these changes are responsible for early memory impairment in AD. The MIMA-P project will combine multi-compartment models of the high-resolution diffusion signal with a cognitive assessment of memory based on recent models of medial temporal lobe function to assess the relevance of a new affordable, rapid and non-invasive early marker of the disease.
Eligibility Criteria
Inclusion Criteria: * aged between 50 and 80 * native French speaking * right-handed * with a level of education equal to or higher than the Certificat d'Etudes Primaires (primary school leaving certificate) * free of any medical or psychiatric condition likely to interfere with cognition, other than a diagnosis of SCD / MCI * affiliated with a social security scheme * having received oral and written information abou the protocol and having signed a consent form to participate in this research * patients with 'subjective cognitive decline-plus' (hereafter 'SCD', criteria of Jessen et al., 2014) or patients with mild neurocognitive impairment due to Alzheimer's disease (hereafter 'MCI', criteria of Albert et al., 2011) Exclusion Criteria: * contraindications to MRI : Abdominal circumference + upper limbs stuck 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. * sensory deficit interfering with experimental tests * pregnant or breast-feeding women * adults under legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty * 7-items modified Hachinski ischemic score \>2 (Hachinski et al., 2012) * Dementia (McKhann et al., 2011)
Contact & Investigator
Pierre-Yves JONIN, PhD
PRINCIPAL INVESTIGATOR
Rennes University Hospital
Frequently Asked Questions
Who can join the NCT06099587 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Alzheimer Disease, Early Onset. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06099587 currently recruiting?
Yes, NCT06099587 is actively recruiting participants. Contact the research team at pierreyves.jonin@chu-rennes.fr for enrollment information.
Where is the NCT06099587 trial being conducted?
This trial is being conducted at Rennes, France.
Who is sponsoring the NCT06099587 clinical trial?
NCT06099587 is sponsored by Rennes University Hospital. The principal investigator is Pierre-Yves JONIN, PhD at Rennes University Hospital. The trial plans to enroll 50 participants.
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