Rifaximin SSD in Dementia Trial

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Dementia Alzheimer Type, Dementia Associated With Cerebrovascular Disease

In brief

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.

Key facts

Study ID

NCT06718686

Run by

Jasmohan Bajaj

People needed

20

Starts

2024-12-30

Expected to finish

2027-12-30

Last updated by the study team

2026-04-03

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Richmond VA Medical Center — Richmond, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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