Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2024-12-30
2026-05-31
Brief Summary
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Detailed Description
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Overall Objective: In a single blind placebo-controlled trial in patients with Alzheimer's or vascular dementia, to determine the effect of rifaximin SSD compared to placebo on gut microbial structure and function, cognitive and daily function, and caregiver burden.
Conditions
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Keywords
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Study Design
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NA
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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Placebo
Patients will be given placebo and actual drug sequentially with the order hidden
Placebo
Placebo drug
Rifaximin SSD 40mg IR BID
Patients will be given placebo and actual drug sequentially with the order hidden
Rifaximin SSD 40 mg IR tablet
Drug therapy vs placebo
Interventions
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Rifaximin SSD 40 mg IR tablet
Drug therapy vs placebo
Placebo
Placebo drug
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
65 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Jasmohan Bajaj
FED
Responsible Party
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Jasmohan Bajaj
Staff Physician
Principal Investigators
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Jasmohan Bajaj
Role: PRINCIPAL_INVESTIGATOR
Richmond VA Medical Center
Locations
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Richmond VA Medical Center
Richmond, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Haley Obolewicz, RN
Role: primary
Other Identifiers
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1817324
Identifier Type: -
Identifier Source: org_study_id