Rifaximin SSD in Dementia Trial

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Change in stool and serum short-chain fatty acid levels [Срок оценки: 10 weeks]
• Change in bile acids in stool and serum [Срок оценки: 10 weeks]

Вторичные конечные точки (12)

• Systemic inflammatory change [Срок оценки: 10 weeks]
• Stool microbiome composition [Срок оценки: 10 weeks]
• Change in dementia biomarkers [Срок оценки: 10 weeks]
• MMSE [Срок оценки: 10 weeks]
• Cognitive testing using Psychometric Hepatic Encephalopathy Score [Срок оценки: 10 weeks]
• Clinical Dementia Rating - Sum of Boxes (CDR-SB) [Срок оценки: 10 weeks]
• EncephalApp Stroop performance [Срок оценки: 10 weeks]
• Critical flicker fusion analysis [Срок оценки: 10 weeks]
• Katz Index of Independence in Activity of Daily Living (ADL) [Срок оценки: 10 weeks]
• Lawton-Brody Instrumental Activities of Daily Living (IADL) [Срок оценки: 10 weeks]
• Zarit Burden Interview short form [Срок оценки: 10 weeks]
• Sickness Impact profile [Срок оценки: 10 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Последовательный дизайн

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Richmond VA Medical Center — Richmond

Идентификаторы

NCT: NCT06718686 · 1817324

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗