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NCT Number: NCT06880406

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nice

Nice, PACA, 06000, France

Location status: Recruiting

Location contact

Aurélie MOUTON, MD,PhD

PRINCIPAL_INVESTIGATOR

Justine Lemaire

CONTACT

[email protected]

33492034778

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MMSE and blood draw

Other

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

Primary outcomes

  1. Mitochondrial oxygen consumption of peripheral blood cells

    Time frame: At Baseline

    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

  2. Mitochondrial oxygen consumption of peripheral blood cells

    Time frame: At 1 year

    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

Secondary outcomes

  1. Mitochondrial metabolomic signature

    Time frame: At Baseline and at one year

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

  2. Mini Mental State Examination Scores for Cognitive Impairment

    Time frame: At Baseline and at one year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Justine Lemaire

CONTACT

[email protected]

33492034778

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: AMPAlz

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 17, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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