RECRUITINGPhase 1 / Phase 2INTERVENTIONAL
Rifaximin SSD in Dementia Trial
Rifaximin in Dementia Trial (RIDE): Gut-Brain Modulation With Rifaximin SSD in Dementia
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Rifaximin SSD 40 mg IR tablet
Drug therapy vs placebo
DRUG
Placebo
Placebo drug
Locations (1)
Richmond VA Medical Center
Richmond, Virginia, United States