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Rifaximin SSD in Dementia Trial

This study is testing a new form of rifaximin SSD, an antibiotic, to see if it can positively change gut microbes in people with Alzheimer's disease (AD) or vascular dementia (VaD). Researchers want to understand if these changes might help with dementia. You may be able to join if you are 65 or older, live in the community, and have mild to moderate AD or VaD. You also need a caregiver who can come with you to study visits. The main goals are to measure changes in certain substances in your stool and blood, called short-chain fatty acids and bile acids, after 10 weeks of treatment. The study aims to enroll 20 participants, but its current status is unclear.

Study design
This is a single-blind, placebo-controlled study, meaning some participants will receive rifaximin SSD and others will receive a placebo (an inactive substance), and you won't know which you are getting. It plans to enroll 20 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary measurements for this study are taken at 10 weeks.

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NCT06718686

Rifaximin SSD in Dementia Trial

Recruiting
PHASE1Ages 65+InterventionalTreatment
Jasmohan Bajaj
~20 participants
Updated 2026-04-03 on ClinicalTrials.gov
What's tested:Rifaximin SSD 40 mg IR tabletPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in stool and serum short-chain fatty acid levels
Measured over 10 weeks
+1 more outcome measured

Conditions

Dementia Alzheimer Type
Dementia Associated With Cerebrovascular Disease

Explore related trials

Alzheimer's DiseaseVascular Dementia

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Jasmohan Bajaj · PRINCIPAL_INVESTIGATOR · Richmond VA Medical Center

Who to contact

Jasmohan S Bajaj, MD
[email protected]
804-675-5802
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 this trial measures

  • Change in stool and serum short-chain fatty acid levels10 weeks

    Change in SCFA in stool and serum in rifaximin SSD phase vs placebo phase

  • Change in bile acids in stool and serum10 weeks

    Change in bile acids in stool and serum in rifaximin SSD phase vs placebo phase