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Mitochondrial Function and Metabolomic Profile in Alzheimer's Disease and Related Dementias

Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With Alzheimer's Disease and Related Dementias

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06880406
Acronym
AMPAlz
Enrollment
250
Registered
2025-03-17
Start date
2025-07-01
Completion date
2029-04-01
Last updated
2026-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Keywords

Alzheimer, mitochondrial function, metabolomic

Brief 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.

Detailed description

Study will be proposed to the patient of the Nice Memory center who had a lumbar puncture and who agreed on the storage of a sample of their cerebrospinal fluid. Two groups of patients will be compared: the Alzheimer"s disease patient with positive amyloid on the cerebrospinal fluid and the non Alzheimer patient with negative amyloid on the cerebrospinal fluid. there will also be a group of healthy volonteer with one blood sample Blood samples will be collected at inclusion and one year to obtain the mitochondrial metabolomic signature

Interventions

OTHERMMSE and blood draw

Each patient will be evaluated by Mini-Mental State Examination (MMSE) and will have a blood draw

Sponsors

Centre Hospitalier Universitaire de Nice
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mitochondrial oxygen consumption of peripheral blood cellsAt BaselineComparison of the rate of mitochondrial oxygen consumption of peripheral blood cells between alzheimer (amyloid positive) and non-Alzheimer participant (amyloid negative) in pmol/min/cell mesured by Extracellular Flux Analyzer

Secondary

MeasureTime frameDescription
Mitochondrial metabolomic signatureAt Baseline and at one yearDescription of the panel of mitochondrial metabolites of peripheral blood cells according to the status of the participants (amyloid positive vs amyloid negative).
Mini Mental State Examination Scores for Cognitive ImpairmentAt Baseline and at one year30 questions, good response to a question = 1, bad response to a question = 0, global scoring between 0 and 30, Pathological threshold according to the socio-cultural level : without diploma : total score \<22 secondary education without the 3rd class : total score \<23 secondary education from 3rd class to the senior year class (without bachelor degree) higher education : total score \<26

Countries

France

Contacts

CONTACTJustine Lemaire
lemaire.j@chu-nice.fr33492034778
PRINCIPAL_INVESTIGATORAurélie MOUTON, MD,PhD

Centre Hospitalier Universitaire de Nice

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 19, 2026