Validation of a fecal test for Alzheimer's disease markers

Validation of a Diagnostic and/or Prognostic Marker for Alzheimer's Disease by Fecal Determination of Amyloid Peptides and Tau Proteins

This study is testing a new stool test to see if it can help detect early signs of Alzheimer's disease in people with the condition, those with cognitive issues, and healthy volunteers.

Quick facts

• Study type: Observational
• Enrollment: 115 (estimated)
• Ages: 40 Years and up
• Sex: All
• Sponsor: University Hospital, Grenoble (Academic / other)
• Locations: 1 site (Grenoble)
• Trial ID: NCT06481878 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate a fecal assay for detecting amyloid peptides and tau proteins as biomarkers for Alzheimer's disease (AD). It focuses on individuals diagnosed with AD, as well as those with cognitive impairments and healthy volunteers, to assess the effectiveness of fecal analysis in early diagnosis. The study seeks to address the challenge of late diagnosis in AD, which often leads to irreversible neurodegeneration. By identifying biomarkers in feces, the research hopes to provide a non-invasive diagnostic tool for early detection of AD.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 40 and older diagnosed with Alzheimer's disease or those with cognitive impairments.

Not a fit: Patients who are younger than 40 or do not have any cognitive impairments may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier diagnosis and intervention for Alzheimer's disease, potentially slowing its progression.

How similar studies have performed: While there have been studies exploring biomarkers for Alzheimer's disease, the use of fecal assays for this purpose is relatively novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

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

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

Exclusion Criteria:

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

Where this trial is running

Grenoble

• Grenoble Alpes University Hospital — Grenoble, France (Recruiting)

Study contacts

• Principal investigator: Mathilde SAUVEE — University Hospital, Grenoble
• Study coordinator: Mathilde SAUVEE

Conditions Alzheimer Disease