Examining mitochondrial function and metabolomic profiles in Alzheimer's disease
Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With Alzheimer's Disease and Related Dementias
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nice Academic / other |
| Locations | 1 site (Nice, PACA) |
| Trial ID | NCT06880406 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with Alzheimer's disease or other neurocognitive disorders as per established diagnostic criteria.
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.
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 performed: 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.
Eligibility criteria
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) Exclusion Criteria: \- Vulnerable people
Where this trial is running
Nice, PACA
- CHU de Nice — Nice, Paca, France (Recruiting)
Study contacts
- Principal investigator: Guillaume SACCO, MD,PhD — Centre Hospitalier Universitaire de Nice
- Study coordinator: Justine Lemaire
- Email: lemaire.j@chu-nice.fr
- Phone: 33492034778
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.