MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease

NCT06099587 | Recruiting

• 1 other identifier: 35RC23_8900_MIMA-P
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease, Early Onset

Keywords

Alzheimer disease; Mild Cognitive Impairment; Subjective cognitive decline-plus; Diffusion MRI; Microstructure; Memory

Outcome Measures

Primary Outcomes (1)

• Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure

  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.

  2 hours and 30 minutes

Secondary Outcomes (2)

• Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure

  2 hours and 30 minutes

• Relationships between medial temporal lobe gray matter microstructure and memory

  2 hours and 30 minutes

Study Arms (2)

SCD+

EXPERIMENTAL

Patients with subjective cognitive decline-plus due to Alzheimer's disease (or "DCS" in french)

Diagnostic Test: high-resolution diffusion MRI

MCI

EXPERIMENTAL

Patients with mild neurocognitive impairment due to Alzheimer's disease (or "TCL" in french)

Diagnostic Test: high-resolution diffusion MRI

Interventions

high-resolution diffusion MRI DIAGNOSTIC_TEST

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).

Also known as: Memory tests

MCI; SCD+

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• items modified Hachinski ischemic score \>2 (Hachinski et al., 2012)
• Dementia (McKhann et al., 2011)

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

CHU Rennes

Rennes, France

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Pierre-Yves JONIN, PhD

  CHU Rennes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Yves JONIN, PhD

CONTACT

299284321; pierreyves.jonin@chu-rennes.fr

Isabelle LEROYER

CONTACT

299289747; isabelle.leroyer@chu-rennes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective single-center

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: July 2, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

FR (1)