Examining mitochondrial function and metabolomic profiles in Alzheimer's disease
Official title: Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With Alzheimer's Disease and Related Dementias
Run by Centre Hospitalier Universitaire de Nice · NCT06880406 · Data updated 2026-11-12
This study is testing if changes in energy production and certain substances in the blood can help us understand Alzheimer's disease better by comparing patients with Alzheimer's to those with other memory problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, PACA) |
| Status | Recruiting |
| Started | July 1, 2025 |
| Main results expected | July 1, 2028 |
| Study ends | April 1, 2029 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT06880406 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with Alzheimer's disease or other neurocognitive disorders as per established diagnostic criteria.
✕Probably not a fit
Patients with neurocognitive disorders not related to Alzheimer's disease who do not meet the inclusion criteria may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project investigates early mitochondrial changes and metabolomic biomarkers in patients with Alzheimer's disease and related dementias. It compares two groups: patients with Alzheimer's disease who have positive amyloid markers in their cerebrospinal fluid and those with other neurocognitive disorders who have negative amyloid markers. Blood samples will be collected at the start and after one year to analyze the mitochondrial metabolomic signature. The study aims to provide insights into the relationship between mitochondrial function and Alzheimer's pathology.
Why it matters
Potential benefit: If successful, this study could lead to the identification of novel biomarkers for early diagnosis and treatment of Alzheimer's disease.
How similar studies have gone: While there have been studies on mitochondrial function and Alzheimer's, this approach combining functional analyses and metabolomic assessments in the same cohort is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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's running
-
CHU de Nice
Nice, Paca, France Recruiting
Study contacts
- Principal investigator: Aurélie MOUTON, MD,PhD — Centre Hospitalier Universitaire de Nice
- Study coordinator: Justine Lemaire
- Email: lemaire.j@chu-nice.fr
- Phone: 33492034778
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.