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RecruitingPhase 1 / Phase 2

Rifaximin SSD in Dementia Trial

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests a new form of rifaximin, an antibiotic that stays in the gut. It looks at whether it can improve gut microbes in people age 65 or older with mild or moderate Alzheimer's disease or vascular dementia.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have likely Alzheimer's disease or vascular dementia (dementia linked to blood flow problems), rated mild or moderate on a dementia scale.
  • Be age 65 or older.
  • Live in the community and have a caregiver who can join study visits and take part in the study.
  • Be able to give consent, or have a legal guardian give consent while you also agree to take part.
  • Have the same person serve as your caregiver and legally authorized representative.
  • You and your caregiver must read, write, and speak English well enough for study visits.

Who can't join

  • Have dementia caused by something other than Alzheimer's disease or vascular dementia.
  • Have agitation or aggression needing antipsychotic medicine; false beliefs or seeing or hearing things that are not there; or a serious mental health condition, including major depression.
  • Have a severe, unstable, or poorly controlled medical condition, or vision or hearing problems that prevent tests of thinking skills.
  • Have diarrhea or an allergy to rifaximin, its ingredients, or any rifamycin antibiotic.
  • Have used antibiotics in the past 6 months.
  • Take medicines that interact with rifaximin. Medicines called P-gp inhibitors are allowed if their use is discussed with the study doctor.
  • Have a history of alcohol or drug abuse.
  • Have taken part in another study testing a drug in the past 30 days.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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

Study sites (1)

VA