Clinical trial NCT06880406: Mitochondrial Function and Metabolomic Profile in Alzheimer's Disease and Related Dementias
Official title: Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With Alzheimer's Disease and Related Dementias
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: Alzheimer
mitochondrial function
metabolomic
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-03-17
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Blood samples will be collected at inclusion and one year to obtain the mitochondrial metabolomic signature

Eligibility 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

Primary outcomes:
measure: Mitochondrial oxygen consumption of peripheral blood cells
timeFrame: At Baseline
measure: Mitochondrial oxygen consumption of peripheral blood cells
timeFrame: At 1 year
Secondary outcomes:
measure: Mitochondrial metabolomic signature
timeFrame: At Baseline and at one year
measure: Mini Mental State Examination Scores for Cognitive Impairment
timeFrame: At Baseline and at one year
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Paca
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Guillaume SACCO, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: