CHU Rennes
Rennes, France
Location status: Recruiting
Location contact
Pierre-Yves JONIN, PhD
CONTACT
Pierre-Yves JONIN, PhD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT06099587
MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
50 year–80 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
The study will combine multi-compartment models (e.g. Archer et al., 2020; Parker et al., 2020) of high-resolution diffusion MRI within medial temporal lobes regions of interest defined through the ASHS algorithm (Yushkevich et al., 2015), with theoretically driven cognitive assessment medial temporal lobes functions. The '4 mountains test' and the 'Memory entities' test will allow specific probing of hippocampal and rhinal cortices functions, respectively (Hartley et al., 2007; Besson et al., 2020).
25 patients with 'subjective cognitive decline-plus' (hereafter 'SCD', criteria of Jessen et al., 2014) and 25 patients with mild neurocognitive impairment due to Alzheimer's disease (hereafter 'MCI', criteria of Albert et al., 2011) matched for gender, socio-professional category and level of education. The 25 healthy volunteers required have already been included in a different study.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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)
Treatment and study plan
high-resolution diffusion MRI
Diagnostic TestThe study will combine multi-compartment models (e.g. Archer et al., 2020; Parker et al., 2020) of high-resolution diffusion MRI within medial temporal lobes regions of interest defined through the ASHS algorithm (Yushkevich et al., 2015), with theoretically driven cognitive assessment medial temporal lobes functions. The '4 mountains test' and the 'Memory entities' test will allow specific probing of hippocampal and rhinal cortices functions, respectively (Hartley et al., 2007; Besson et al., 2020).
Other names: Memory tests
Primary outcomes
-
Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure
Time frame: 2 hours and 30 minutes
Free-water and free-water corrected Fractional anisotropy are two parameters that can be estimated through Multi-Compartment Modelling of the diffusion MRI signal within medial temporal lobes gray matter. We will compute these parameters for the hippocampus and the surroundings rhinal cortices. These measures will be compared between patients and healthy controls.
Secondary outcomes
-
Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure
Time frame: 2 hours and 30 minutes
Free-water and free-water corrected Fractional anisotropy are two parameters that can be estimated through Multi-Compartment Modelling of the diffusion MRI signal within medial temporal lobes gray matter. We will compute these parameters for the hippocampus and the surroundings rhinal cortices. These measures will be compared across patients groups.
-
Relationships between medial temporal lobe gray matter microstructure and memory
Time frame: 2 hours and 30 minutes
Free-water and free-water corrected Fractional anisotropy are two parameters that can be estimated through Multi-Compartment Modelling of the diffusion MRI signal within medial temporal lobes gray matter. We will compute these parameters for the hippocampus and the surroundings rhinal cortices. Memory accuracy scores will be computed for the two memory tasks "The '4 mountains test' and the 'Memory entities' test" . Correlational analyses will be performed across groups between gray matter microstructure estimates and memory scores.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Rennes University Hospital
Other
Registry information
Acronym: MIMA-P
Important dates
- Study start
- 2024
- Primary completion
- 2028
- Study completion
- 2029
- First posted
- Oct 25, 2023
- Registry last updated
- Jun 17, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
A Multifocal tDCS-EEG Protocol for Improving Symptoms of Mild Cognitive Impairment and Early Dementia
NCT06668610
Alzheimer Disease, Alzheimer Disease, Early Onset
Caserta, Italy
View Trial Details
Recruiting
Repurposing Nucleoside Reverse Transcriptase Inhibitors for Treatment of AD
NCT04500847
Alzheimer Disease, Alzheimer Disease, Early Onset
Los Angeles, California, United States
View Trial Details
Recruiting
GnRH Therapy on Cognition in Down Syndrome
NCT04390646
Abnormalities, Multiple, Alzheimer Disease
Lausanne, Canton of Vaud, Switzerland
View Trial Details
Active, Not Recruiting
A Pivotal Study of Sensory Stimulation in Alzheimer's Disease (HOPE Study)
NCT05637801
Alzheimer Disease, Alzheimer Disease 1
Gilbert, Arizona, United States
View Trial Details