Rifaximin in Dementia Trial (RIDE): Gut-Brain Modulation With Rifaximin SSD in Dementia
Jasmohan Bajaj
Summary
Using a new formulation of rifaximin, a non-absorbable antibiotic, to test if it can affect microbes in the gut of patients with dementia favorably.
Description
Hypothesis: Rifaximin SSD therapy is safe and well tolerated in patients with AD and VaD with beneficial changes in systemic inflammation and systemic biomarkers of dementia due to improvement in microbiota function compared to placebo-related changes in a single-blind, placebo-controlled Phase 1b/2a trial . Overall Objective: In a single blind placebo-controlled trial in patients with Alzheimer's or vascular dementia, to determine the effect of rifaximin SSD compared to placebo on gut microbial structure and function, cognitive and daily function, and caregiver burden.
Eligibility
- Age range
- 65+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Probable Alzheimer's Disease (AD) or Vascular Dementia (VaD) mild or moderate based on Clinical Dementia Rating Scale. * Males and Females Age ≥ 65 years * Community living with availability of caregiver to accompany participant to study visits and to participate in the study. * Able to consent or legal guardian who can consent (with participant assent). * Legally authorized representative (LAR) and caregiver for the study is the same individual. * Fluency (both participant and caregiver) in written and spoken English to participate in study visits. Exclusion Criteria:…
Interventions
- DrugRifaximin SSD 40 mg IR tablet
Drug therapy vs placebo
- DrugPlacebo
Placebo drug
Location
- Richmond VA Medical CenterRichmond, Virginia