BridgeMD
New treatment option for Dementia Alzheimer Type
Official title Rifaximin SSD in Dementia Trial
ClinicalTrials.gov ID: NCT06718686
What this study is testing
What is Rifaximin SSD 40 mg IR tablet?
Rifaximin SSD 40 mg IR tablet is an investigational medicine, given as an once-daily, being studied as a potential treatment for dementia alzheimer type.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.