Alzheimer DiseaseFecAlzNCT06481878
Validation of an Alzheimer's Disease Marker by Fecal Assay of Amyloid Peptides and Tau Proteins
An observational study of Alzheimer Disease, run by University Hospital, Grenoble at 1 site in France.
Trial summary
Alzheimer's disease (AD) is the leading cause of dementia in humans, currently affecting almost one million people in France. It results from an irreversible degeneration of neurons responsible for a progressive decline in the main cognitive and memory functions due to a cerebral accumulation of plaques containing… Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- faecal analysis
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- 11 Oct 2024to 6 Oct 2027
- Phase
- Observational
- 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 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Single-center study, recruitment among patients consulting the CMRR of the Alpine arc
Who may be able to join
- For subjects with Alzheimer's disease MA TCM (A+ T+):
- Subjects diagnosed with AD according to IWG 2021 criteria
- Subject at the stage of major cognitive impairment
- At least 40 years of age
- Presence of a caregiver or support person
- No informed opposition
Show all 25Show fewer
- For subjects with AD TCm (A+ T+):
- Subject diagnosed with AD according to IWG 2021 criteria
- Subject at the stage of minor cognitive impairment
- Minimum age 40
- No informed opposition For subjects with minor or major cognitive impairment who do not have AD TC Non-AD LCR negative (A- T-)
- Subject at stage of minor or major cognitive impairment
- CSF negative (A-T-) for Alzheimer's disease biomarkers: A-T- according to ATN classification
- Minimum age 40
- No informed objection and TCm CSFdiscordant (A+ T-) or (A- T+):
- Subject at stage of minor cognitive impairment
- CSF discordant (A-T+ or A+T-) with Alzheimer's disease biomarkers
- Minimum age 40
- No informed opposition
- For healthy volunteers (VS) :
- No cognitive complaints
- MMSE ≥ 26
- CDR 0
- Minimum age 40
- No informed opposition
Who cannot join
- For MA TCM (A+ T+), MA TCm (A+T+) and TC Non MA LCR negatif (A-T-) and TCm LCRdiscordant (A+ T-) or (A- T+):
- Inability to understand search instructions or to give informed non-opposition
- Absence of social security affiliation or plan
- Persons covered by articles L1121-5 to L1121-8 of the CSP (legally protected adult, subject under administrative or judicial supervision)
- For healthy volunteers:
- Incapacity to understand research instructions or to give informed non-opposition
- Persons covered by articles L1121-5 to L1121-8 of the CSP (legally protected adult, subject under administrative or judicial supervision)
- Absence of social security affiliation or of such a scheme
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
Grenoble Alpes University Hospital
Grenoble, 38043
Sandrine KEIGNART, 33 (0)4 76 76 62 32, SKeignart@chu-grenoble.fr
Mathilde SAUVEE
About this study
Official title: Validation of a Diagnostic and/or Prognostic Marker for Alzheimer's Disease by Fecal Determination of Amyloid Peptides and Tau Proteins
Alzheimer's disease (AD) is the leading cause of dementia in humans, currently affecting almost one million people in France. It results from an irreversible degeneration of neurons responsible for a progressive decline in the main cognitive and memory functions due to a cerebral accumulation of plaques containing fibrillary amyloid peptide (Aβ) and neurofibrillary tangles composed of truncated, hyperphosphorylated tau protein (pTau).
There is currently no curative treatment for this disease in France. However, two treatments aimed at reducing beta-amyloid plaques in the brain have been approved by the U.S. Food and Drug Administration. The failure of the latest therapeutic strategies is largely due to the fact that the disease is diagnosed too late, starting with a long asymptomatic phase, which is the one that needs to be targeted in order to prevent irreversible neurodegenerative mechanisms.
Read more
The development of diagnostic tools is gradually making it possible to detect such a sequence, but this has its drawbacks (radioactive load, invasive procedure, cumbersome set-up).
Over the last ten years, research has focused on the development of plasma or salivary markers. Although encouraging, these studies show either a lack of sensitivity or reproducibility, or a lack of specificity or precocity.
The expression of Aβ and Tau proteins has recently been demonstrated in the enteric nervous system and enterocytes. Intestinal Aβ is involved in various gut functions and regulation.
What recent work by investigators demonstrates is the essential and hitherto unrecognized role of the gut-brain axis in maintaining brain homeostasis. In a mouse model of AD, the investigators have demonstrated a mechanism for intestinal elimination (clearance) of toxic brain forms of Tau and Aβ proteins, via the lymphatic network.
The clearance of cerebral Tau and Aβ proteins in the stool may constitute a reliable and powerful diagnostic signature of AD. Its study would represent a new, non-invasive and easily accessible technique for the early diagnosis of AD in humans.
- Conditions
- Alzheimer Disease
- Being tested
- faecal analysis
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
faecal analysisDiagnostic test
Collection of medical data and stool sampling
| Study group | Role | What they receive |
|---|---|---|
| 35 MA TCM (A+ T+) | Group of patients with established Alzheimer's disease at the stage of major cognitive impairment Receives: Diagnostic Test: faecal analysis | |
| 15 MA TCm (A+ T+) | Group of patients with established Alzheimer's disease at the stage of minor cognitive impairment Receives: Diagnostic Test: faecal analysis | |
| 15 TC Non MA LCR negatif (A- T-) | Group of patients with minor or major cognitive impairment but without AD Receives: Diagnostic Test: faecal analysis | |
| 15 TCm LCRdiscordant (A+ T-) ou (A- T+) | Group of patients with minor cognitive impairment and discordant CSF Receives: Diagnostic Test: faecal analysis | |
| 35 VS | Group of healthy volunteers Receives: Diagnostic Test: faecal analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the amount of fibrillar and oligomeric amyloid peptide and phosphorylated tau protein measured in the stools of subjects issued as soon as possible after recruitment
Quantity of AD biomarkers in stool.
The biomarkers studied will be :
In Lumipulse (CHUGA platform): beta-amyloid 42,beta-amyloid 40, Ptau and total tau.
Dotblot (GIN): Soluble forms of phosphorylated tau (Tau-pThre205, Tau-pThre181, Tau-pThre217, Tau-pser404) or total tau (panTau), as well as toxic oligomeric forms of the beta-amyloid peptide (E22P). Finally, insoluble fibrillar forms of Tau (AT8) and beta-amyloid peptide (OC).
Measured: Between inclusion and Month 6
Secondary outcomes (3)
To observe the evolution and kinetics of AD biomarkers in subjects with Alzheimer's disease at the stage of minor cognitive impairment (AD TCm A+ T+).
Quantity of AD biomarkers in the stool of subjects with Alzheimer's disease at the TCm stage between M6 and M12 (AD TCm A+ T+)
Measured: between Month 6 and Month 12
Follow the efficacy of a treatment if the AD TCm (A+ T+) subject takes one
Increase or decrease in the quantity of AD biomarkers in the stool of subjects with Alzheimer's disease at the TCm stage under treatment between M6 and M12 (AD TCm A+ T+).
Measured: between Month 6 and Month 12
Observe the evolution and kinetics of AD biomarkers in subjects without Alzheimer's disease at the stage of minor cognitive impairment (TCm LCRdiscordant).
Quantity of AD biomarkers in the stool of non-Alzheimer's subjects at stage TCm CSFdiscordant) between M6 and M12
Measured: between Month 6 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start11 Oct 2024
- Primary completion6 Oct 2027 (estimated)
- Study completion6 Oct 2027 (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, GrenobleThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 115 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathilde SAUVEE, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481878
- Sponsor's protocol ID
- 38RC24.0026
- Other IDs
- 2024-A00378-39
- Acronym
- FecAlz
- Status last verified
- Apr 2026
- First submitted
- 31 May 2024
- Last updated
- 5 May 2026
- 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 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Diagnostic and/or Prognostic Marker for Alzheimer's Disease by Fecal Determination of Amyloid Peptides and Tau Proteins
- ClinicalTrials.gov ID
- NCT06481878
- Acronym / sponsor ID
- FecAlz / 38RC24.0026
- Conditions
- Alzheimer Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 115 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 6 Oct 2027 (estimated)
- Study completion
- 6 Oct 2027 (estimated)
- First posted
- 1 Jul 2024 (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.
Alzheimer's disease (AD) is the leading cause of dementia in humans, currently affecting almost one million people in France. It results from an irreversible degeneration of neurons responsible for a progressive decline in the main cognitive and memory functions due to a cerebral accumulation of plaques containing fibrillary amyloid peptide (Aβ) and neurofibrillary tangles composed of truncated, hyperphosphorylated tau protein (pTau).
There is currently no curative treatment for this disease in France. However, two treatments aimed at reducing beta-amyloid plaques in the brain have been approved by the U.S. Food and Drug Administration. The failure of the latest therapeutic strategies is largely due to the fact that the disease is diagnosed too late, starting with a long asymptomatic phase, which is the one that needs to be targeted in order to prevent irreversible neurodegenerative mechanisms.
The development of diagnostic tools is gradually making it possible to detect such a sequence, but this has its drawbacks (radioactive load, invasive procedure, cumbersome set-up).
Over the last ten years, research has focused on the development of plasma or salivary markers. Although encouraging, these studies show either a lack of sensitivity or reproducibility, or a lack of specificity or precocity.
The expression of Aβ and Tau proteins has recently been demonstrated in the enteric nervous system and enterocytes. Intestinal Aβ is involved in various gut functions and regulation.
What recent work by investigators demonstrates is the essential and hitherto unrecognized role of the gut-brain axis in maintaining brain homeostasis. In a mouse model of AD, the investigators have demonstrated a mechanism for intestinal elimination (clearance) of toxic brain forms of Tau and Aβ proteins, via the lymphatic network.
The clearance of cerebral Tau and Aβ proteins in the stool may constitute a reliable and powerful diagnostic signature of AD. Its study would represent a new, non-invasive and easily accessible technique for the early diagnosis of AD in humans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 35 MA TCM (A+ T+) | – | Diagnostic Test: faecal analysisGroup of patients with established Alzheimer's disease at the stage of major cognitive impairment |
| 15 MA TCm (A+ T+) | – | Diagnostic Test: faecal analysisGroup of patients with established Alzheimer's disease at the stage of minor cognitive impairment |
| 15 TC Non MA LCR negatif (A- T-) | – | Diagnostic Test: faecal analysisGroup of patients with minor or major cognitive impairment but without AD |
| 15 TCm LCRdiscordant (A+ T-) ou (A- T+) | – | Diagnostic Test: faecal analysisGroup of patients with minor cognitive impairment and discordant CSF |
| 35 VS | – | Diagnostic Test: faecal analysisGroup of healthy volunteers |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Single-center study, recruitment among patients consulting the CMRR of the Alpine arc
Key inclusion criteria (25 listed)
- Subjects diagnosed with AD according to IWG 2021 criteria
- Subject at the stage of major cognitive impairment
- At least 40 years of age
- Presence of a caregiver or support person
- No informed opposition
Key exclusion criteria (8 listed)
- For MA TCM (A+ T+), MA TCm (A+T+) and TC Non MA LCR negatif (A-T-) and TCm LCRdiscordant (A+ T-) or (A- T+):
- Inability to understand search instructions or to give informed non-opposition
- Absence of social security affiliation or plan
- Persons covered by articles L1121-5 to L1121-8 of the CSP (legally protected adult, subject under administrative or judicial supervision)
- Incapacity to understand research instructions or to give informed non-opposition
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 |
|---|---|---|
| faecal analysisCollection of medical data and stool sampling | Diagnostic test | 15 MA TCm (A+ T+), 15 TC Non MA LCR negatif (A- T-), 15 TCm LCRdiscordant (A+ T-) ou (A- T+), 35 MA TCM (A+ T+), 35 VS |
Primary outcome
to determine the amount of fibrillar and oligomeric amyloid peptide and phosphorylated tau protein measured in the stools of subjects issued as soon as possible after recruitment
Time frame: Between inclusion and Month 6
Quantity of AD biomarkers in stool. The biomarkers studied will be : In Lumipulse (CHUGA platform): beta-amyloid 42,beta-amyloid 40, Ptau and total tau. Dotblot (GIN): Soluble forms of phosphorylated tau (Tau-pThre205, Tau-pThre181, Tau-pThre217, Tau-pser404) or total tau (panTau), as well as toxic oligomeric forms of the beta-amyloid peptide (E22P). Finally, insoluble fibrillar forms of Tau (AT8) and beta-amyloid peptide (OC).
3 secondary outcomes
To observe the evolution and kinetics of AD biomarkers in subjects with Alzheimer's disease at the stage of minor cognitive impairment (AD TCm A+ T+).
Time frame: between Month 6 and Month 12
Follow the efficacy of a treatment if the AD TCm (A+ T+) subject takes one
Time frame: between Month 6 and Month 12
Observe the evolution and kinetics of AD biomarkers in subjects without Alzheimer's disease at the stage of minor cognitive impairment (TCm LCRdiscordant).
Time frame: between Month 6 and Month 12
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 5 May 2026.
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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.
Mathilde SAUVEE principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, run by University Hospital, Grenoble 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 25 inclusion and 8 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 5 May 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 Mathilde SAUVEE (33 (0)4 76 76 57 90, MSauvee@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to determine the amount of fibrillar and oligomeric amyloid peptide and phosphorylated tau protein measured in the stools of subjects issued as soon as possible after recruitment (time frame: Between inclusion and Month 6). 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 5 May 2026.