Menu
Recruiting NCT06718686

Rifaximin SSD in Dementia Trial

Phase I / Phase II Interventional Dementia Alzheimer Type Dementia Associated With Cerebrovascular Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Rifaximin SSD 40 mg IR tablet, Placebo.
Who it may be relevant to
Registry conditions: Dementia Alzheimer Type, Dementia Associated With Cerebrovascular Disease. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Rifaximin in Dementia Trial (RIDE): Gut-Brain Modulation With Rifaximin SSD in Dementia

Overview

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.

Interventions

  • Drug Rifaximin SSD 40 mg IR tablet
    Drug therapy vs placebo
  • Drug Placebo
    Placebo drug

Primary outcome measures

  • Change in stool and serum short-chain fatty acid levels [Time frame: 10 weeks]
  • Change in bile acids in stool and serum [Time frame: 10 weeks]
Secondary outcome measures (12)
  • Systemic inflammatory change [Time frame: 10 weeks]
  • Stool microbiome composition [Time frame: 10 weeks]
  • Change in dementia biomarkers [Time frame: 10 weeks]
  • MMSE [Time frame: 10 weeks]
  • Cognitive testing using Psychometric Hepatic Encephalopathy Score [Time frame: 10 weeks]
  • Clinical Dementia Rating - Sum of Boxes (CDR-SB) [Time frame: 10 weeks]
  • EncephalApp Stroop performance [Time frame: 10 weeks]
  • Critical flicker fusion analysis [Time frame: 10 weeks]
  • Katz Index of Independence in Activity of Daily Living (ADL) [Time frame: 10 weeks]
  • Lawton-Brody Instrumental Activities of Daily Living (IADL) [Time frame: 10 weeks]
  • Zarit Burden Interview short form [Time frame: 10 weeks]
  • Sickness Impact profile [Time frame: 10 weeks]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Sequential
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Richmond VA Medical Center — Richmond

Identifiers

NCT: NCT06718686 · 1817324

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗