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

Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With 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.

Study Overview

• Status: Recruiting
• Conditions: Alzheimer Disease
• Intervention / Treatment: Other: MMSE and blood draw

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

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Justine Lemaire; Phone Number: 33492034778; Email: lemaire.j@chu-nice.fr

Study Locations

• France
  • Paca
    • Nice, Paca, France, 06000
      • Recruiting
      • CHU de Nice
      • Contact: Justine Lemaire; Phone Number: 33492034778; Email: lemaire.j@chu-nice.fr
      • Principal Investigator: Guillaume SACCO, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: MMSE and blood draw; Each patient will be evaluated by Mini-Mental State Examination (MMSE) and will have a blood draw

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	At 1 year
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	At Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	At Baseline and at one year
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	At Baseline and at one year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: Guillaume SACCO, MD,PhD, Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: March 7, 2025
• First Submitted That Met QC Criteria: March 11, 2025
• First Posted (Actual): March 17, 2025

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Alzheimer; metabolomic; mitochondrial function
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Dementia
• Other Study ID Numbers: 24-PP-19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No