CHU de Nice
Nice, PACA, 06000, France
Location status: Recruiting
NCT Number: NCT06880406
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Nice, PACA, 06000, France
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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:
Exclusion criteria
Each patient will be evaluated by Mini-Mental State Examination (MMSE) and will have a blood draw
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
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
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).
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
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire de Nice
Other
Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With Alzheimer's Disease and Related Dementias
Acronym: AMPAlz
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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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