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

Study acronym: MIMA-P
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Primary completion pushed from Jul 2026 to Jul 3, 2028
    • Study completion pushed from Mar 2027 to Mar 2, 2029
    v4
  2. Minor Re-verified, no change to tracked fieldsv3
  3. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Primary completion date: Nov 2025 to Jul 2026
    • Start date changed from estimate of Nov 2023 to Jul 2, 2024
    • Study completion date: Jul 2026 to Mar 2027
    • Site details revised
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06099587
Lead Sponsor Rennes University Hospital
Conditions
(from sponsor)
Alzheimer Disease, Early Onset
Related terms Alzheimer Disease, Cognitive Dysfunction
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov