Mitochondrial Function and Metabolomic Profile in Alzheimer's Disease and Related Dementias (NCT06880406) | Clinical Trial Compass
RecruitingNot Applicable
Mitochondrial Function and Metabolomic Profile in Alzheimer's Disease and Related Dementias
France250 participantsStarted 2025-07-01
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study seems focused on measuring mitochondrial function in blood cells rather than testing a new treatment — can you help me understand what I or my family member would actually gain from participating, since it appears to be observational rather than offering a new therapy?
2The trial is measuring mitochondrial oxygen consumption from peripheral blood — what does that involve practically, like how much blood would be drawn and how many visits would be required, and would that fit with our current care schedule?
3Since this is listed as Phase NA, which often means it's a non-interventional or observational study, does that mean there's no experimental treatment being tested, and how does that change the risk-benefit calculation compared to a drug trial?
4Could the data collected from this study about mitochondrial and metabolomic profiles eventually help guide my loved one's treatment decisions, or is the benefit more likely to help future patients down the line?
5Are there any standard diagnostic workups or treatments for Alzheimer's we should be prioritizing right now, and would participating in this research study in any way interfere with or delay those options?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mitochondrial oxygen consumption of peripheral blood cells
Timeframe: At Baseline
2
Mitochondrial oxygen consumption of peripheral blood cells