Studying Mitochondria and Metabolites in Early Alzheimer's and Related Dementias
Studies early mitochondrial changes and metabolite markers in blood cells of adults with Alzheimer's disease.
Key facts
- Who runs it
- Centre Hospitalier Universitaire de Nice
- Where
- Nice, FranceSee the site
- Trial code
- Registry title
- Mitochondrial Function and Metabolomic Profile in Alzheimer's Disease and Related Dementias
- Status
- Recruiting
- People taking part
- 250 people, planned
- Started
- 1 Jul 2025
- Expected to end
- 1 Apr 2029
- Type of study
- Interventional
- Treatments tested
- MMSE and blood draw
- Record updated
- 18 June 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with memory or thinking problems from Alzheimer's disease or another dementia, and for healthy adult volunteers.
- Age
- 18 years or older
- Sex
- All sexes
- Disease stage
- Patients with a mild or major neurocognitive disorder (memory and thinking problems), with or without Alzheimer's disease.
- Biomarker or test result
- Alzheimer group: signs of the Alzheimer amyloid process in the cerebrospinal fluid. Non-Alzheimer group: no such signs in the cerebrospinal fluid.
Main reasons for not taking part
- Vulnerable people
- Healthy volunteers: any history of neurological or psychiatric disorders
- Healthy volunteers: memory or thinking complaints
- Healthy volunteers: MMSE score below 27/30
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- Vulnerable people
Where in France
- CHU de NiceNice, FranceContact: Justine LemaireTaking people
About the trial
What the trial wants to find out
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.
The group in the trial
- ALZHEIMER PATIENTS and NON ALZHEIMER PATIENTSTreatment being tested
Recruitment of 75 patients with amyloid positive marker on cerebrospinal fluid and 75 patients with amyloid negative marker on cerebrospinal fluid and 75 healthy volonteers
Treatment: MMSE and blood draw
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With Alzheimer's Disease and Related Dementias
- Plain-language title
- Studying Mitochondria and Metabolites in Early Alzheimer's and Related DementiasGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 18 June 2026