RecruitingAlzheimer Disease
The Gut - PRO Study
Eligible age
60+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: University of Wisconsin, Madison
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ Active or previous (within 6 months) participation in an Alzheimer's clinical intervention/trial (can be included if previously enrolled in placebo or control group)
- ✕ Standard clinical care for dementia and medications used to treat MCI and Alzheimer's disease are acceptable, including monoclonal antibody therapy
- ✕ Significant neurologic disease: Any significant neurologic disease, such as Parkinson's disease, stroke, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, subdural hematoma, multiple sclerosis, seizure disorder, or other significant deficits other than Alzheimer's or Mild Cognitive Impairment
- ✕ Alcohol/substance: history of alcohol/substance dependence in the past year.
- ✕ Significant medical illness: any significant systemic illness or unstable medical condition occurring during ADRC participation that could affect cognition (other than MCI/AD). Examples include malignant cancer, chemotherapy, HIV, untreated thyroid disease, heart failure, or renal insufficiency
- ✕ Current diagnosis with diabetes
- ✕ Illiterate, blind, or non-English speaking
- ✕ Known periodic antibiotic use (i.e., prior to dental appointments)
Where it's recruiting
Wisconsin
Madison
Source: ClinicalTrials.gov · NCT07413744 · last updated 2026-09-21