Exploring brain microstructure in early Alzheimer's disease
MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease
This study is trying to see if special brain scans can help identify early signs of Alzheimer's disease in people with mild cognitive issues and those who feel their memory is slipping.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 50 Years to 80 Years |
| Sex | All |
| Sponsor | Rennes University Hospital Academic / other |
| Locations | 1 site (Rennes) |
| Trial ID | NCT06099587 on ClinicalTrials.gov |
What this trial studies
This study investigates the microstructural changes in the medial temporal lobe of patients with Mild Cognitive Impairment (MCI) and Subjective Cognitive Decline (SCD) using high-resolution diffusion MRI. By combining advanced imaging techniques with cognitive assessments, the study aims to identify early biomarkers that could predict the progression to Alzheimer's disease. A total of 50 participants will be enrolled, including 25 with SCD, 25 with MCI, and 25 healthy volunteers from a previous study. The goal is to enhance diagnostic precision and potentially delay the onset of Alzheimer's disease.
Who should consider this trial
Good fit: Ideal candidates are French-speaking, right-handed individuals aged 50 to 80 with either subjective cognitive decline or mild neurocognitive impairment due to Alzheimer's disease.
Not a fit: Patients with conditions that interfere with cognition or those who cannot undergo MRI due to medical contraindications will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier and more accurate identification of individuals at risk for Alzheimer's disease, allowing for timely interventions.
How similar studies have performed: Other studies utilizing diffusion MRI to assess brain microstructure in Alzheimer's disease have shown promising results, indicating that this approach is both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Rennes
- CHU Rennes — Rennes, France (Recruiting)
Study contacts
- Principal investigator: Pierre-Yves JONIN, PhD — Rennes University Hospital
- Study coordinator: Pierre-Yves JONIN, PhD
- Email: pierreyves.jonin@chu-rennes.fr
- Phone: 299284321
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.