Alzheimer DiseaseMICMALZNCT04841135
Blood Microbiota Signature of Alzheimer's Disease
A study testing Multiomics quantification and Polysomnography in people with Alzheimer Disease and Elderly With Normal Cognition, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study aims to validate a difference in blood microbial signature between Alzheimer's patients and control subjects in order to propose potential innovative strategies Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Elderly With Normal Cognition
- What is being tested?
- Multiomics quantification and Polysomnography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2021to Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- General criteria for AD and control groups:
- Male and/or female;
- Age between 50-85 years;
- Having given their free, informed, written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
- Patient benefiting from a social security scheme
- AD group:
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- Diagnosis of Alzheimer's disease according to the international ATN criteria of Albert et al, (1) who had a diagnostic lumbar puncture and CSF biomarker assay and brain imaging with analysis of hippocampal atrophy; topographic and pathophysiological markers must be positive to confirm the etiopathogenic diagnosis;
- Mild to moderate stage with MMSE score between 10 and 26 ;
- Symptomatic treatments specific to Alzheimer's disease (acetylcholinesterase inhibitors and memantine) and psychotropic treatments (anxiolytics, antidepressants, neuroleptics) are authorized but must be at fixed doses for more than 3 months ;
- Control group:
- Patients seen in memory consultation for concern of having AD but for whom the workup is normal. These patients will have had a diagnostic lumbar puncture during the same memory consultation.
- Neurotypical group criteria:
- Male and/or female ;
- Age between 18-35 years or between 50-85 years;
- Having given their free, informed, written and signed consent by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
- Patients without cognitive complaints seen in memory consultation but for whom the assessment is normal or young subjects recruited by advertisement. These participants will have an ex-post determination of plasma Aß and tau biomarkers.
Who cannot join
- General criteria for AD and control groups:
- Absence of a family caregiver to complete the neuropsychological scales and questionnaires ;
- Patient living in a medical institution;
- Illiteracy or inability to complete the psycho-behavioral tests;
- Major physical or neurosensory problems likely to interfere with the tests;
- Contra-indication or refusal to perform the biological tests;
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- Refusal to carry out neuropsychological tests.
- Refusal of stool collection
- Digestive neoplasia in progress or < 5 years old
- Digestive surgery with intestinal resection ;
- Presence of inflammatory bowel disease or other familial gastrointestinal pathology ;
- Chronic use of laxatives;
- Antibiotics taken within one month prior to inclusion;
- Short-term life-threatening conditions (active cancer, unstable heart failure, severe liver, kidney and respiratory failure);
- Chronic psychosis or psychotic episodes;
- Alcohol or drug addiction;
- Epilepsy and other non-degenerative diseases of the central nervous system
- Vitamin B12 deficiency and unsupplemented folic acid ;
- Untreated hypothyroidism;
- Patient deprived of liberty, by judicial or administrative decision;
- Major protected by law;
- Patient in a period of relative exclusion from another protocol;
- Refusal to participate in the protocol.
- AD group :
- Insufficient clinical and paraclinical information for the diagnosis of AD;
- Genetic form of AD (known genetic mutation);
- Control and neurotypical groups: No specific non-inclusion criteria
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Montpellier university hospital
Montpellier
Karim BENNYS, MD, PhD, +33 4 67 33 72 32, k-bennys@chu-montpellier.fr
Sylvie CLAEYSEN, +33 4 34 35 92 15, sylvie.claeysen@igf.cnrs.fr
About this study
Official title: Analysis of the Blood Signature of the Microbiota as a Diagnostic Marker of Alzheimer's Disease in the Early Stages of the Process: Pilot Study
This study aims to validate a difference in blood microbial signature between Alzheimer's patients and control subjects in order to propose potential innovative strategies
Read the detailed description
This is a pilot study only carried out in Montpellier, aimed at comparing AD patients with control subjects, including men / women aged between 50 and 85 years. The diagnosis of AD patients is based on international criteria. Metagenomics and proteomics will be used to determine the composition of the microbiota in whole blood and stools, but also the metabolomic profile in plasma, stool and the urines.
- Conditions
- Alzheimer Disease, Elderly With Normal Cognition
- Being tested
- Multiomics quantification, Polysomnography
- Keywords
- Alzheimer, Memory, Aging, Microbiota
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiomics quantificationOther
One time blood, stool and urine samples will be taken.
PolysomnographyOther
Facultative polysomnography
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer disease group | Other | Not described Receives: Other: Multiomics quantification; Other: Polysomnography |
| Control | Other | Not described Receives: Other: Multiomics quantification; Other: Polysomnography |
| Neurotypicals | Other | Not described Receives: Other: Multiomics quantification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of bacterial 16S rDNA in stools
Concentration of bacterial 16S rDNA in stools
Measured: 22 months
Secondary outcomes (2)
Concentration of bacterial 16s DNA in blood
Concentration of bacterial 16s DNA in blood
Measured: 22 months
Multiomics microbiota signature in AD
Multiomics microbiota signature in AD
Measured: 22 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start3 Jun 2021
- Primary completionApr 2024 (estimated)
- Study completionJan 2026 (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 University Hospital, MontpellierThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim BENNYS, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04841135
- Sponsor's protocol ID
- RECHMPL19_0041
- Acronym
- MICMALZ
- Status last verified
- Apr 2023
- First submitted
- 8 Apr 2021
- Last updated
- 20 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Blood Signature of the Microbiota as a Diagnostic Marker of Alzheimer's Disease in the Early Stages of the Process: Pilot Study
- ClinicalTrials.gov ID
- NCT04841135
- Acronym / sponsor ID
- MICMALZ / RECHMPL19_0041
- Conditions
- Alzheimer Disease, Elderly With Normal Cognition
- Keywords
- Alzheimer, Memory, Aging, Microbiota
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 3 Jun 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 12 Apr 2021 (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 study aims to validate a difference in blood microbial signature between Alzheimer's patients and control subjects in order to propose potential innovative strategies
Detailed description
This is a pilot study only carried out in Montpellier, aimed at comparing AD patients with control subjects, including men / women aged between 50 and 85 years. The diagnosis of AD patients is based on international criteria. Metagenomics and proteomics will be used to determine the composition of the microbiota in whole blood and stools, but also the metabolomic profile in plasma, stool and the urines.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alzheimer disease group | Other | Other: Multiomics quantification, Other: Polysomnography |
| Control | Other | Other: Multiomics quantification, Other: Polysomnography |
| Neurotypicals | Other | Other: Multiomics quantification |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male and/or female;
- Age between 50-85 years;
- Having given their free, informed, written consent, signed by the participant and the investigator (at the latest on the day of inclusion and before any examination required by the research);
- Patient benefiting from a social security scheme
- Diagnosis of Alzheimer's disease according to the international ATN criteria of Albert et al, (1) who had a diagnostic lumbar puncture and CSF biomarker assay and brain imaging with analysis of hippocampal atrophy; topographic and pathophysiological markers must be positive to confirm the etiopathogenic diagnosis;
Key exclusion criteria (27 listed)
- Absence of a family caregiver to complete the neuropsychological scales and questionnaires ;
- Patient living in a medical institution;
- Illiteracy or inability to complete the psycho-behavioral tests;
- Major physical or neurosensory problems likely to interfere with the tests;
- Contra-indication or refusal to perform the biological tests;
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 |
|---|---|---|
| Multiomics quantificationOne time blood, stool and urine samples will be taken. | Other | Alzheimer disease group, Control, Neurotypicals |
| PolysomnographyFacultative polysomnography | Other | Alzheimer disease group, Control |
Primary outcome
Concentration of bacterial 16S rDNA in stools
Time frame: 22 months
Concentration of bacterial 16S rDNA in stools
2 secondary outcomes
Concentration of bacterial 16s DNA in blood
Time frame: 22 months
Multiomics microbiota signature in AD
Time frame: 22 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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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. This study is not recruiting at the moment.
Karim BENNYS, MD, PhD principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiomics quantification and Polysomnography in people with Alzheimer Disease and Elderly With Normal Cognition, run by University Hospital, Montpellier 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 16 inclusion and 27 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: status not confirmed, as of the sponsor's last update on 20 Apr 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karim BENNYS, MD, PhD (+33 4 67 33 72 32, k-bennys@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of bacterial 16S rDNA in stools (time frame: 22 months). 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 20 Apr 2023.