Clinical trial NCT06718686: Rifaximin SSD in Dementia Trial
Official title: Rifaximin in Dementia Trial (RIDE): Gut-Brain Modulation With Rifaximin SSD in Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Dementia Alzheimer Type
Dementia Associated With Cerebrovascular Disease
Keywords: dementia
rifaximin
gut-brain
Alzheimer&#39;s
vascular dementia
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2024-12-05
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Hypothesis: Rifaximin SSD therapy is safe and well tolerated in patients with AD and VaD with beneficial changes in systemic inflammation and systemic biomarkers of dementia due to improvement in microbiota function compared to placebo-related changes in a single-blind, placebo-controlled Phase 1b/2a trial .

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.

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

Primary outcomes:
measure: Change in stool and serum short-chain fatty acid levels
timeFrame: 10 weeks
measure: Change in bile acids in stool and serum
timeFrame: 10 weeks
Secondary outcomes:
measure: Systemic inflammatory change
timeFrame: 10 weeks
measure: Stool microbiome composition
timeFrame: 10 weeks
measure: Change in dementia biomarkers
timeFrame: 10 weeks
measure: MMSE
timeFrame: 10 weeks
measure: Cognitive testing using Psychometric Hepatic Encephalopathy Score
timeFrame: 10 weeks
measure: Clinical Dementia Rating - Sum of Boxes (CDR-SB)
timeFrame: 10 weeks
measure: EncephalApp Stroop performance
timeFrame: 10 weeks
measure: Critical flicker fusion analysis
timeFrame: 10 weeks
measure: Katz Index of Independence in Activity of Daily Living (ADL)
timeFrame: 10 weeks
measure: Lawton-Brody Instrumental Activities of Daily Living (IADL)
timeFrame: 10 weeks
measure: Zarit Burden Interview short form
timeFrame: 10 weeks
measure: Sickness Impact profile
timeFrame: 10 weeks
measure: PROMIS-29
timeFrame: 10 weeks
measure: Safety
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Richmond VA Medical Center
state: Virginia
Study officials:
affiliation: Richmond VA Medical Center
name: Jasmohan Bajaj
role: PRINCIPAL_INVESTIGATOR
References: