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

Recruitingn/aAges 40 Years - anyAllUniversity Hospital, Grenoble
NCT06481878 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 (Aฮฒ) 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 mec

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ 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
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What it tests

  • faecal analysis
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Where

1 site
Grenoble Alpes University Hospital
Grenoble, France
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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