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Could a gut pill boost brain health in dementia?

NCT ID NCT06718686

Disease control Sponsor: Jasmohan Bajaj Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new version of a gut antibiotic called rifaximin in 20 people with mild-to-moderate Alzheimer's or vascular dementia. The goal is to see if changing the bacteria in the gut can improve brain function and reduce inflammation. Participants will take the drug or a placebo in two phases, and researchers will measure changes in blood and stool markers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Alzheimer disease dementia vascular dementia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dementia Alzheimer type Dementia associated with cerebrovascular disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Richmond VA Medical Center

    RECRUITING

    Richmond, Virginia, 23249, United States

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