Rifaximin SSD in Dementia Trial (NCT06718686) | Clinical Trial Compass
RecruitingPhase 1/2
Rifaximin SSD in Dementia Trial
United States20 participantsStarted 2024-12-30
Plain-language 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.
Who can participate
Age range65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 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
What they're measuring
1
Change in stool and serum short-chain fatty acid levels