Alzheimer Disease, Early OnsetMIMA-PNCT06099587
MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease
A study testing high-resolution diffusion MRI in people with Alzheimer Disease, Early Onset, run by Rennes University Hospital at 1 site in France.
Trial 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%. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Alzheimer Disease, Early Onset
- What is being tested?
- high-resolution diffusion MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jul 2024to 2 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Rennes
Rennes
Pierre-Yves JONIN, PhD
Pierre-Yves JONIN, PhD
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Early Onset
- Being tested
- high-resolution diffusion MRI
- Keywords
- Alzheimer disease, Mild Cognitive Impairment, Subjective cognitive decline-plus, Diffusion MRI, Microstructure, Memory
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high-resolution diffusion MRIDiagnostic test
Also called Memory tests
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).
| Study group | Role | What they receive |
|---|---|---|
| SCD+ | Experimental | Patients with subjective cognitive decline-plus due to Alzheimer's disease (or "DCS" in french) Receives: Diagnostic Test: high-resolution diffusion MRI |
| MCI | Experimental | Patients with mild neurocognitive impairment due to Alzheimer's disease (or "TCL" in french) Receives: Diagnostic Test: high-resolution diffusion MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours and 30 minutes
Secondary outcomes (2)
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.
Measured: 2 hours and 30 minutes
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.
Measured: 2 hours and 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start2 Jul 2024
- Primary completion3 Jul 2028 (estimated)
- Study completion2 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Prospective single-center
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Yves JONIN, PhD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06099587
- Sponsor's protocol ID
- 35RC23_8900_MIMA-P
- Acronym
- MIMA-P
- Status last verified
- Jun 2026
- First submitted
- 19 Oct 2023
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06099587
- Acronym / sponsor ID
- MIMA-P / 35RC23_8900_MIMA-P
- Conditions
- Alzheimer Disease, Early Onset
- Keywords
- Alzheimer disease, Mild Cognitive Impairment, Subjective cognitive decline-plus, Diffusion MRI, Microstructure, Memory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- 3 Jul 2028 (estimated)
- Study completion
- 2 Mar 2029 (estimated)
- First posted
- 25 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective single-center
| Arm | Type | Receives |
|---|---|---|
| SCD+ | Experimental | Diagnostic Test: high-resolution diffusion MRIPatients with subjective cognitive decline-plus due to Alzheimer's disease (or "DCS" in french) |
| MCI | Experimental | Diagnostic Test: high-resolution diffusion MRIPatients with mild neurocognitive impairment due to Alzheimer's disease (or "TCL" in french) |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| high-resolution diffusion MRIAlso: Memory testsThe 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). | Diagnostic test | MCI, SCD+ |
Primary outcome
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.
2 secondary outcomes
Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure
Time frame: 2 hours and 30 minutes
Relationships between medial temporal lobe gray matter microstructure and memory
Time frame: 2 hours and 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pierre-Yves JONIN, PhD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high-resolution diffusion MRI in people with Alzheimer Disease, Early Onset, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre-Yves JONIN, PhD (299284321 ext. +33, pierreyves.jonin@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure (time frame: 2 hours and 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.