Validation of a fecal test for Alzheimer's disease markers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Grenoble Alpes University Hospital
  Grenoble, France Recruiting

Study contacts

• Principal investigator: Mathilde SAUVEE — University Hospital, Grenoble
• Study coordinator: Mathilde SAUVEE
• Email: MSauvee@chu-grenoble.fr
• Phone: 33 (0)4 76 76 57 90

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.