Probiotic Supplementation Safety and Feasibility Study in Preclinical Alzheimer's Disease
University of Wisconsin, Madison
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.
Description
40 participants will be enrolled. 20 with dementia or mild cognitive impairment (MCI) due to Alzheimer's disease (biomarker confirmed amyloid positivity), and 20 unimpaired cognition, enriched for elevated amyloid (approximately 75-80% amyloid positive). Dementia/mild cognitive impairment will be determined according to 2024 NIA-AA criteria. Primary Objective * To assess the safety and feasibility (recruitment, eligibility, enrollment, completion, and follow-up) of an oral probiotic supplementation (PS) intervention in humans with or at risk for dementia due to AD. Exploratory Objectives *…
Eligibility
- Age range
- 60+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * MCI/AD or cognitively unimpaired, referred from a Wisconsin clinic that is part of the Wisconsin Alzheimer's Institute's (WAI) network, or recruited from the community. May have participated in: * Alzheimer's Disease Research Center (ADRC) clinical core study (2011-0030) * ADCP (26695, MCW IRB) * Synapse study (2018-1283) * ADRC Recruitment Registry (2016-0735) * At least 60 years of age or older * Good general health (other than cognitive impairment/dementia) with no conditions/medications affecting the gut microbiome (see exclusion criteria below) * Willing an…
Interventions
- DrugProbiotic
A single dose of oral PS will be administered once daily for 6 months
- OtherPlacebo
A placebo will be given once daily for 6 months.
Location
- University of Wisconsin Hospitals and ClinicsMadison, Wisconsin