Rifaximin SSD in Dementia Trial
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorJasmohan Bajaj
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- Rifaximin SSD 40 mg IR tablet
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Jasmohan Bajaj
Lead sponsor
Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor institution
Bausch Health Americas, Inc.
Collaborator
Source ClinicalTrials.gov