Rifaximin SSD in Dementia Trial

Launched by JASMOHAN BAJAJ · Dec 2, 2024

Keywords

ClinConnect Summary

The Rifaximin SSD in Dementia Trial is studying a new form of rifaximin, a type of antibiotic that doesn't get absorbed into the bloodstream, to see if it can positively influence the bacteria in the gut of people living with dementia, specifically those with Alzheimer's Disease or vascular dementia. The trial is currently looking for participants aged 65 and older who have been diagnosed with mild to moderate forms of these types of dementia. To be eligible, participants must live in the community and have a caregiver who can help them attend study visits.

If you or a loved one qualifies for this trial, you can expect to be part of research that aims to understand how this antibiotic might help with dementia symptoms. Participants will need to be able to provide consent, or have a legal guardian who can do so for them. It's important to note that certain medical conditions and medications may exclude someone from participating, so a thorough check of eligibility will be conducted. This study hopes to shed light on how gut health may relate to brain health in dementia patients, potentially paving the way for new treatments.

Gender

ALL

Eligibility 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