Probiotic Supplementation Safety and Feasibility Study in Preclinical Alzheimer's Disease

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: DOUBLE
• Enrollment: 40 participants

Interventions

• DRUG: Probiotic — A single dose of oral PS will be administered once daily for 6 months
• OTHER: Placebo — A placebo will be given once daily for 6 months.

Primary Outcomes

• 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 All Oral PS (week 24)

Trial Locations

• University of Wisconsin Hospitals and Clinics, Madison, Wisconsin, United States

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