Probiotic Supplementation Safety and Feasibility Study in Preclinical Alzheimer's Disease
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Safety: Proportion of participants with an adverse event (AE) occurring during any point of the study
Overview
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.
Detailed 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
- To demonstrate the effects of PS on the composition and function of the gut microbiota in humans with or at risk for dementia due to AD.
- To collect preliminary data in order to estimate sample size and other critical parameters for a larger study.
- To examine potential mechanisms by which the gut impacts brain, including leading candidate mechanisms such as intestinal permeability and change to bile acid milieu.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •Willing and able to comply with all study procedures for the duration of the study
- •Able to provide signed and dated informed consent form
- •Participant is not pregnant, lactating or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile)
- •Able to take oral medications
- •An informant to answer questionnaires about the participant
- •Additional inclusion criteria for unimpaired participants:
- •Has MOCA score that falls within the range defined for cognitively healthy individuals
- •Additional inclusion criteria for participants with MCI/AD
- •Abnormal cognitive function documented by neuropsychological testing
- •ADRC (2015-0030) Consensus Diagnosis Conference indicates dementia or MCI due to AD (for ADRC, ADCP, and Synapse participants only)
Arms & Interventions
Cognitively Impaired due to AD: Probiotic
Diagnosis of mild cognitive impairment (MCI) or dementia
Intervention: Probiotic (Drug)
Cognitively Impaired due to AD: Placebo
Diagnosis of mild cognitive impairment (MCI) or dementia
Intervention: Placebo (Other)
Cognitively Unimpaired Amyloid Positive: Probiotic
Intervention: Probiotic (Drug)
Cognitively Unimpaired Amyloid Positive: Placebo
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Safety: Proportion of participants with an adverse event (AE) occurring during any point of the study
Time Frame: up to 36 weeks
Safety: Proportion of participants with a severe adverse event (SAE) occurring during any point of the study
Time Frame: up to 36 weeks
Feasibility: Number of weeks or months needed to meet study group numbers
Time Frame: up to 36 weeks
Feasibility: Proportion of individuals expressing interest in study who are Eligible
Time Frame: baseline
Feasibility: Proportion of Participants Who Complete All Oral PS
Time Frame: week 24
Feasibility: Proportion of Participants Who Complete Intervention
Time Frame: up to 36 weeks
Secondary Outcomes
No secondary outcomes reported