MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease
New MRI Technique Explores Early Alzheimer's Brain Changes
Plain English Summary
MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease is a Not Applicable clinical trial sponsored by Rennes University Hospital studying Alzheimer Disease, Early Onset. This study tests a new MRI method to look at tiny changes in the brain's memory center. It's for individuals aged 50-80 who have mild memory concerns or a diagnosis of Mild Cognitive Impairment (MCI). Participants will undergo a special MRI scan and memory tests. Current alternatives include cognitive tests, standard imaging, and invasive blood/spinal fluid tests. The trial aims to enroll 50 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 50 and 80 years old, speak French, are right-handed, and have at least a primary school education. You must have mild memory concerns or Mild Cognitive Impairment (MCI) and no other major medical or psychiatric conditions that could affect thinking. You cannot join if you have MRI contraindications (like pacemakers or claustrophobia), significant sensory deficits, are pregnant or breastfeeding, or have advanced dementia. This trial is studying Alzheimer Disease, Early Onset, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The study measures tiny changes in the brain's gray matter using a special MRI, which helps understand how these changes might be affecting memory in the early stages of Alzheimer's. The specific primary outcome measures are: Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure (2 hours and 30 minutes). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to find a better, non-invasive way to detect early signs of Alzheimer's disease, which is crucial for timely intervention and potentially delaying disease progression. This research targets Alzheimer Disease, Early Onset, where improved treatment options are needed.
Investor Insight
This pilot study explores a novel, potentially more accessible diagnostic tool for early Alzheimer's, addressing a significant unmet need in a large and growing market.
Is This Trial Right for Me?
Ask your doctor if this study is right for you and what the MRI procedure involves. Participation includes a specialized MRI scan and memory assessments, taking about 2.5 hours. You will need to be able to lie still in the MRI machine and understand French. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 50 participants
Interventions
- DIAGNOSTIC_TEST: high-resolution diffusion MRI — 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., 2
Primary Outcomes
- Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure (2 hours and 30 minutes)
Secondary Outcomes
- 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)
Full 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)
Trial Locations
- CHU Rennes, Rennes, France
Frequently Asked Questions
What is clinical trial NCT06099587?
NCT06099587 is a Not Applicable INTERVENTIONAL study titled "MIMA Pilot Study: MIcrostructure of the Medial Temporal Lobe in Early Alzheimer's Disease." It is currently recruiting and is sponsored by Rennes University Hospital. The trial targets enrollment of 50 participants.
What conditions does NCT06099587 study?
This trial investigates treatments for Alzheimer Disease, Early Onset. The primary condition under study is Alzheimer Disease, Early Onset.
What treatments are being tested in NCT06099587?
The interventions being studied include: 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., 2
What does Not Applicable mean for NCT06099587?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT06099587?
This trial is currently "Recruiting." It started on 2024-07-02. The estimated completion date is 2027-03.
Who is sponsoring NCT06099587?
NCT06099587 is sponsored by Rennes University Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06099587?
The trial aims to enroll 50 participants. The trial is currently recruiting and accepting new participants.
How is NCT06099587 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT06099587?
The primary outcome measures are: Diffusion-MRI based parameters estimates of medial temporal lobe gray matter microstructure (2 hours and 30 minutes). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06099587 being conducted?
This trial is being conducted at 1 site, including Rennes (France).
Where can I find official information about NCT06099587?
The official record for NCT06099587 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06099587. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06099587 testing in simple terms?
This study tests a new MRI method to look at tiny changes in the brain's memory center. It's for individuals aged 50-80 who have mild memory concerns or a diagnosis of Mild Cognitive Impairment (MCI).
Why is this trial significant?
This trial aims to find a better, non-invasive way to detect early signs of Alzheimer's disease, which is crucial for timely intervention and potentially delaying disease progression.
What are the potential risks of participating in NCT06099587?
The main risk is discomfort or anxiety related to the MRI scan, especially if you are claustrophobic. Potential side effects are generally mild and related to the MRI procedure, such as temporary headache or dizziness. There are no known risks associated with the diagnostic information gathered by the MRI itself. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06099587?
Ask your doctor if this study is right for you and what the MRI procedure involves. Participation includes a specialized MRI scan and memory assessments, taking about 2.5 hours. You will need to be able to lie still in the MRI machine and understand French. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06099587 signal from an investment perspective?
This pilot study explores a novel, potentially more accessible diagnostic tool for early Alzheimer's, addressing a significant unmet need in a large and growing market. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will undergo a special MRI scan and memory tests. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Alzheimer Disease, Early Onset Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.