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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Nice

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • MMSE and blood draw

    Other intervention

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

Treatment groups

250 Participants
are divided into 1 treatment group
Group A: ALZHEIMER PATIENTS and NON ALZHEIMER PATIENTSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Mitochondrial oxygen consumption of peripheral blood cells

Comparison 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

Time frame
At Baseline
2

Mitochondrial oxygen consumption of peripheral blood cells

Comparison 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

Time frame
At 1 year

Secondary outcomes

1

Mitochondrial metabolomic signature

Description of the panel of mitochondrial metabolites of peripheral blood cells according to the status of the participants (amyloid positive vs amyloid negative).

Time frame
At Baseline and at one year
2

Mini Mental State Examination Scores for Cognitive Impairment

30 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

Time frame
At Baseline and at one year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.