Alzheimer Disease
Conditions
Keywords
probiotics
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.
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.
Sponsors
University of Wisconsin, Madison
International Flavors & Fragrances Inc.
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Safety and feasibility study, randomized, double blinded, placebo-controlled
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
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 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) * Meets NIA-AA criteria for MCI or AD.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Contacts
CONTACTAlfred Braceros, BA
PRINCIPAL_INVESTIGATORBarbara Bendlin, PhD
UW School of Medicine and Public Health
PRINCIPAL_INVESTIGATORFederico Rey, PhD
Department of Bacteriology
Outcome results
None listed