Clinical trial Recruiting at 1 site Interventional Ages 18 and up

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 typeInterventional
Ages18 Years and up
SexAll
Enrollment250 (estimated)
SponsorCentre Hospitalier Universitaire de Nice
Academic / other
Locations1 site (Nice, PACA)
StatusRecruiting
StartedJuly 1, 2025
Main results expectedJuly 1, 2028
Study endsApril 1, 2029
Registry record updatedJune 18, 2026
Trial IDNCT06880406 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.