Testing rifaximin for improving gut health in dementia patients
Official title: Rifaximin in Dementia Trial (RIDE): Gut-Brain Modulation With Rifaximin SSD in Dementia
Run by Hunter Holmes Mcguire Veteran Affairs Medical Center · NCT06718686 · Data updated 2026-11-12
This study is testing if a new form of rifaximin can improve gut health and help people with Alzheimer's and Vascular Dementia feel better and function more effectively.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 65 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Hunter Holmes Mcguire Veteran Affairs Medical Center Federal |
| Locations | 1 site (Richmond, Virginia) |
| Status | Recruiting |
| Started | December 30, 2024 |
| Main results expected | October 30, 2027 |
| Study ends | December 30, 2027 |
| Registry record updated | April 3, 2026 |
| Trial ID | NCT06718686 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 65 and older with mild to moderate Alzheimer's Disease or Vascular Dementia who can provide consent or have a legal guardian to do so.
✕Probably not a fit
Patients with dementia not due to Alzheimer's or Vascular Dementia, or those with severe psychiatric conditions, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of a new formulation of rifaximin, a non-absorbable antibiotic, on gut microbiota in patients with Alzheimer's Disease (AD) and Vascular Dementia (VaD). It aims to determine whether rifaximin SSD can lead to beneficial changes in systemic inflammation and biomarkers associated with dementia. The study is designed as a single-blind, placebo-controlled trial, comparing the effects of rifaximin to a placebo on cognitive function, daily living activities, and caregiver burden. Participants will be monitored for safety and tolerability throughout the trial.
Why it matters
Potential benefit: If successful, this treatment could improve cognitive function and quality of life for patients with dementia.
How similar studies have gone: While the approach of targeting gut microbiota in dementia is novel, similar studies have shown promising results in other conditions, suggesting potential for success.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Richmond VA Medical Center
Richmond, Virginia, United States Recruiting
Study contacts
- Principal investigator: Jasmohan Bajaj — Richmond VA Medical Center
- Study coordinator: Jasmohan S Bajaj, MD
- Email: jasmohan.bajaj@vcuhealth.org
- Phone: 804-675-5802
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.