RecruitingPhase 1Phase 2NCT06718686

Rifaximin SSD in Dementia Trial

Rifaximin in Dementia Trial (RIDE): Gut-Brain Modulation With Rifaximin SSD in Dementia

Sponsor

Jasmohan Bajaj

Enrollment

20 participants

Start Date

Dec 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.

Min Age: 65 Years

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.

Dementia not due to AD or VaD
Clinically significant agitation or aggression (requiring treatment with antipsychotic medication)
Delusions and/or hallucinations
Severe psychopathology including major depression
Unstable, severe, or poorly controlled medical conditions evident from physical examination or clinical history
Visual and/or hearing disorder that prevents completion of neuropsychologic evaluations.
Diarrhea
Hypersensitivity to rifaximin, components of rifaximin,
and any rifamycin antimicrobial agent
Antibiotic use in the prior 6 months
Taking medications that interact with Rifaximin. P-glycoprotein (P-gp) inhibitor treatment is permitted as long as the use of P-gp inhibitors is discussed with the investigator.
History of alcohol and/or drug abuse
Participation in another investigational drug trial in the last 30 days