NCT06880406Recruiting
Mitochondrial Function and Metabolomic Profile in Alzheimer's Disease and Related Dementias
Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With Alzheimer's Disease and Related Dementias
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 7 Mar 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 1 Jul 2028
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Diseases
- Alzheimer disease
- NCT number
- NCT06880406
What you commit to
- Study type: Interventional
- Planned participants: 250
- From 1 Jul 2025 to the primary completion date, 1 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- \- Vulnerable people
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.