NCT06481878 · RECRUITING
Validation of an Alzheimer's Disease Marker by Fecal Assay of Amyloid Peptides and Tau Proteins
This trial is testing whether Alzheimer's-related proteins — amyloid and tau — can be detected in stool samples. The idea is that the brain may clear these toxic proteins through the gut, making a simple fecal test a possible early diagnostic tool. This is a validation study, not a treatment trial, so it is focused on proving whether the test works, not on any therapy. Details on phase are not specified.
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2024-10-28