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

Centre Hospitalier Universitaire de Nice

Status: Enrolling

Conditions: Alzheimer Disease

Treatments: Other: MMSE and blood draw

Study type: Interventional

Funder types: Other

Identifiers

NCT06880406

24-PP-19

Details and patient eligibility

About

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.

Full 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

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 1 patient group

ALZHEIMER PATIENTS and NON ALZHEIMER PATIENTS

Experimental group

Description:

Recruitment of 75 patients with amyloid positive marker on cerebrospinal fluid and 75 patients with amyloid negative marker on cerebrospinal fluid

Treatment:

Other: MMSE and blood draw