Mitochondrial Function and Metabolomic Profile in Alzheimer's Disease and Related Dementias
Recruiting · NCT06880406 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier Universitaire de Nice
View the official record on ClinicalTrials.gov →Interventions studied
MMSE and blood draw
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- CHU de Nice - Nice, PACA, France