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

Primary Purpose

Alzheimer Disease, Early Onset

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high-resolution diffusion MRI
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease, Early Onset focused on measuring Alzheimer disease, Mild Cognitive Impairment, Subjective cognitive decline-plus, Diffusion MRI, Microstructure, Memory

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • CHU Rennes

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

SCD+

MCI

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 across patients groups.
Relationships between medial temporal lobe gray matter microstructure and memory
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.

Full Information

First Posted
October 19, 2023
Last Updated
October 19, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06099587
Brief Title
MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease
Acronym
MIMA-P
Official Title
MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
November 2025 (Anticipated)
Study Completion Date
July 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Early Onset
Keywords
Alzheimer disease, Mild Cognitive Impairment, Subjective cognitive decline-plus, Diffusion MRI, Microstructure, Memory

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective single-center
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SCD+
Arm Type
Experimental
Arm Description
Patients with subjective cognitive decline-plus due to Alzheimer's disease (or "DCS" in french)
Arm Title
MCI
Arm Type
Experimental
Arm Description
Patients with mild neurocognitive impairment due to Alzheimer's disease (or "TCL" in french)
Intervention Type
Diagnostic Test
Intervention Name(s)
high-resolution diffusion MRI
Other Intervention Name(s)
Memory tests
Intervention Description
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).
Primary Outcome Measure Information:
Title
Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure
Description
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.
Time Frame
2 hours and 30 minutes
Secondary Outcome Measure Information:
Title
Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure
Description
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.
Time Frame
2 hours and 30 minutes
Title
Relationships between medial temporal lobe gray matter microstructure and memory
Description
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.
Time Frame
2 hours and 30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Yves JONIN, PhD
Phone
299284321
Ext
+33
Email
pierreyves.jonin@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle LEROYER
Phone
299289747
Ext
+33
Email
isabelle.leroyer@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves JONIN, PhD
Organizational Affiliation
CHU Rennes
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes
City
Rennes
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Yves JONIN, PhD
First Name & Middle Initial & Last Name & Degree
Pierre-Yves JONIN, PhD

12. IPD Sharing Statement

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

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