Alzheimer DiseaseAMPAlzNCT06880406
Mitochondrial Function and Metabolomic Profile in Alzheimer's Disease and Related Dementias
A study testing MMSE and blood draw in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- MMSE and blood draw
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2025to 1 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- Vulnerable people
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, PACA, 06000
Justine Lemaire, 33492034778, lemaire.j@chu-nice.fr
Aurélie MOUTON, MD,PhD
About this study
Official title: 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.
Read the 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.
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
- Conditions
- Alzheimer Disease
- Being tested
- MMSE and blood draw
- Keywords
- Alzheimer, mitochondrial function, metabolomic
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MMSE and blood drawOther
Each patient will be evaluated by Mini-Mental State Examination (MMSE) and will have a blood draw
| Study group | Role | What they receive |
|---|---|---|
| ALZHEIMER PATIENTS and NON ALZHEIMER PATIENTS | Experimental | Recruitment of 75 patients with amyloid positive marker on cerebrospinal fluid and 75 patients with amyloid negative marker on cerebrospinal fluid and 75 healthy volonteers Receives: Other: MMSE and blood draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At Baseline
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
Measured: At 1 year
Secondary outcomes (2)
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).
Measured: 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
Measured: At Baseline and at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2025
- Study start1 Jul 2025
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aurélie MOUTON, MD,PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06880406
- Sponsor's protocol ID
- 24-PP-19
- Acronym
- AMPAlz
- Status last verified
- Jun 2026
- First submitted
- 7 Mar 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Alterations of Peripheral Mitochondrial Function and Metabolomic Profile in Patients With Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT06880406
- Acronym / sponsor ID
- AMPAlz / 24-PP-19
- Conditions
- Alzheimer Disease
- Keywords
- Alzheimer, mitochondrial function, metabolomic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 17 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALZHEIMER PATIENTS and NON ALZHEIMER PATIENTS | Experimental | Other: MMSE and blood drawRecruitment of 75 patients with amyloid positive marker on cerebrospinal fluid and 75 patients with amyloid negative marker on cerebrospinal fluid and 75 healthy volonteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (1 listed)
- Vulnerable people
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MMSE and blood drawEach patient will be evaluated by Mini-Mental State Examination (MMSE) and will have a blood draw | Other | ALZHEIMER PATIENTS and NON ALZHEIMER PATIENTS |
Primary outcome
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
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
2 secondary outcomes
Mitochondrial metabolomic signature
Time frame: At Baseline and at one year
Mini Mental State Examination Scores for Cognitive Impairment
Time frame: At Baseline and at one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aurélie MOUTON, MD,PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MMSE and blood draw in people with Alzheimer Disease, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justine Lemaire (33492034778, lemaire.j@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mitochondrial oxygen consumption of peripheral blood cells (time frame: At Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.