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