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Alzheimer Disease / Probiotic · Phase 1 Trial
ClinicalTrials.gov · September 4, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 1 registration for a safety and feasibility study of oral probiotic supplementation in individuals with Alzheimer's disease or mild cognitive impairment. The study has not yet begun recruitment and contains no outcome data; it is intended to establish tolerability, adverse event rates, and enrollment feasibility prior to larger trials.
Phase 1, Interventional, Randomized, Parallel, Double masking, Treatment purpose. Alzheimer Disease; age from 60 Years; accepts healthy volunteers. Intervention: Cognitively Impaired due to AD: Probiotic; Cognitively Unimpaired Amyloid Positive: Probiotic. Compared with: Cognitively Impaired due to AD: Placebo — Placebo Comparator; Cognitively Unimpaired Amyloid Positive: Placebo — Placebo Comparator. n = 40. 1 site: United States.
This is a Phase 1 registration for a safety and feasibility study of oral probiotic supplementation in individuals with Alzheimer's disease or mild cognitive impairment. The study has not yet begun recruitment and contains no outcome data; it is intended to establish tolerability, adverse event rates, and enrollment feasibility prior to larger trials.
No efficacy endpoints are specified; primary outcomes are safety and feasibility measures.
This preliminary registration describes a planned Phase 1 study. Clinicians should not interpret this as evidence of efficacy; results, when available, will address only safety tolerability and feasibility in this population. Any therapeutic claim for probiotics in Alzheimer's disease remains premature.
This is a Phase 1 safety and feasibility trial in a neurodegenerative disease population with no results yet posted; it is designed to generate early evidence on tolerability and enrollment, not to establish efficacy.
As stated by the source record.
Quoted from the source exactly as published.
This preliminary registration describes a planned Phase 1 study. Clinicians should not interpret this as evidence of efficacy; results, when available, will address only safety tolerability and feasibility in this population. Any therapeutic claim for probiotics in Alzheimer's disease remains premature.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07413744). This is a study registration, not published results. Lead sponsor: University of Wisconsin, Madison. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 40 participants (ESTIMATED). Conditions: Alzheimer Disease. Interventions: DRUG: Probiotic; OTHER: Placebo. Primary outcome measures: Safety: Proportion of participants with an adverse event (AE) occurring during any point of the study , up to 36 weeks; Safety: Proportion of participants with a severe adverse event (SAE) occurring during any point of the study , up to 36 weeks; Feasibility: Number of weeks or months needed to meet study group numbers , up to 36 weeks; Feasibility: Proportion of individuals expressing interest in study who are Eligible , baseline; Feasibility: Proportion of Participants Who Complete 80 percent of Oral PS , week 24; Feasibility: Proportion of Participants Who Complete Intervention , up to 36 weeks. Brief summary: The purpose of this study is to assess the safety and feasibility of an oral probiotic supplement (PS) intervention in individuals with dementia or mild-cognitive impairment (MCI) due to Alzheimer's disease or at risk of dementia due to Alzheimer's disease (AD). 40 participants will be enrolled and can expect to be on study for up to 1 year.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.