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Clinical Trials in France / NCT06880406
Recruiting Not applicable

Mitochondrial Function and Metabolomic Profile in Alzheimer's Disease and Related Dementias

NCT06880406 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Nice
Phase
Not applicable
Started
2025-07-01
Last updated
2026-06-18

Condition(s) studied

Alzheimer Disease

Investigational drug(s) / intervention(s)

MMSE and blood draw

MMSE and blood draw: Each patient will be evaluated by Mini-Mental State Examination (MMSE) and will have a blood draw

Study summary

This project aims to study on one hand the early mitochondrial alterations, common or specific, occurring in peripheral cells of patients with Alzheimer's disease or related dementia and, on the other hand, identify the metabolomic biomarkers that may be at the origin of mitochondrial disturbances associated with the disease. This will be the first study combining functional analyses of mitochondria and exploratory metabolomic assessments in the same cohort at early stages of the disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Neurocognitive disorder with spontaneous complaint or reported for at least 6 months * Diagnostic process according to current Haute Autorité de Santé (HAS) recommendations. * cerebrospinal fluid biomarker dosage done within the study center and agreement to bio-collection of residual cerebrospinal fluid * Patient having agreed to sign the informed consent * Patient affiliated or beneficiary of a social security scheme For alzheimer group : diagnosis of Alzheimer's disease according to NIA-AA 2024 criteria (presence of a pathogenic amyloid process in the cerebrospinal fluid) For non alzheimer group : diagnosis of mild or major neurocognitive disorder according to Manuel diagnostique et statistique des troubles mentaux edition 5 (DSM-V) criteria, not linked to Alzheimer's disease (absence of pathogenic amyloid process in the cerebrospinal fluid) For healthy volonteers: * Adult patients * No history of neurological or psychiatric disorders * No complaints of memory problems or cognitive impairment * Mini-Mental State Examination (MMSE) score ≥ 27/30 * Clinical Dementia Rating - Sum of Boxes (CDR-SOB) equal to 0 * Patient affiliated with or covered by a social security scheme Exclusion Criteria: \- Vulnerable people

Primary outcome measure(s)

  • Mitochondrial oxygen consumption of peripheral blood cells — At Baseline
    Comparison of the rate of mitochondrial oxygen consumption of peripheral blood cells between alzheimer (amyloid positive) and non-Alzheimer participant (amyloid negative) in pmol/min/cell mesured by Extracellular Flux Analyzer
  • Mitochondrial oxygen consumption of peripheral blood cells — At 1 year
    Comparison of the rate of mitochondrial oxygen consumption of peripheral blood cells between alzheimer (amyloid positive) and non-Alzheimer participant (amyloid negative) in pmol/min/cell mesured by Extracellular Flux Analyzer

Trial sites (1)

FacilityCityRegionStatus
CHU de Nice Nice PACA Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06880406 on ClinicalTrials.gov ↗ ← All trials in France