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Recruiting Phase 1, Phase 2 NCT06718686

Rifaximin SSD in Dementia Trial

Trial Parameters

Condition Dementia Alzheimer Type
Sponsor Jasmohan Bajaj
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 20
Sex ALL
Min Age 65 Years
Max Age N/A
Start Date 2024-12-30
Completion 2025-12
Interventions
Rifaximin SSD 40 mg IR tabletPlacebo

Brief 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.

Eligibility Criteria

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: * 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 neuropsy

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