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NCT06481878Recruiting

Validation of an Alzheimer's Disease Marker by Fecal Assay of Amyloid Peptides and Tau Proteins

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

Source: ClinicalTrials.gov · Last updated 5 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
115 (estimated)
First submitted
31 May 2024
Start date
11 Oct 2024
Primary completion date
6 Oct 2027
Lead sponsor
University Hospital, Grenoble
NCT number
NCT06481878

What you commit to

  • Study type: Observational
  • Planned participants: 115
  • From 11 Oct 2024 to the primary completion date, 6 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Grenoble Alpes University Hospital
Coordinator of this site? Confirm its status
GrenobleFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.