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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2029-04-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Alzheimer Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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ALZHEIMER PATIENTS and NON ALZHEIMER PATIENTS

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

Group Type EXPERIMENTAL

MMSE and blood draw

Intervention Type OTHER

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

Interventions

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MMSE and blood draw

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

Intervention Type OTHER

Eligibility Criteria

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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)