Rifaximin in Dementia Trial (RIDE): Gut-Brain Modulation With Rifaximin SSD in Dementia
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in stool and serum short-chain fatty acid levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
- •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
研究组 & 干预措施
Placebo
Patients will be given placebo and actual drug sequentially with the order hidden
干预措施: Placebo (Drug)
Rifaximin SSD 40mg IR BID
Patients will be given placebo and actual drug sequentially with the order hidden
干预措施: Rifaximin SSD 40 mg IR tablet (Drug)
结局指标
主要结局
Change in stool and serum short-chain fatty acid levels
时间窗: 10 weeks
Change in SCFA in stool and serum in rifaximin SSD phase vs placebo phase
Change in bile acids in stool and serum
时间窗: 10 weeks
Change in bile acids in stool and serum in rifaximin SSD phase vs placebo phase
次要结局
- Systemic inflammatory change(10 weeks)
- Stool microbiome composition(10 weeks)
- Change in dementia biomarkers(10 weeks)
- MMSE(10 weeks)
- Cognitive testing using Psychometric Hepatic Encephalopathy Score(10 weeks)
- Clinical Dementia Rating - Sum of Boxes (CDR-SB)(10 weeks)
- EncephalApp Stroop performance(10 weeks)
- Critical flicker fusion analysis(10 weeks)
- Katz Index of Independence in Activity of Daily Living (ADL)(10 weeks)
- Lawton-Brody Instrumental Activities of Daily Living (IADL)(10 weeks)
- Zarit Burden Interview short form(10 weeks)
- Sickness Impact profile(10 weeks)
- PROMIS-29(10 weeks)
- Safety(10 weeks)
研究者
Jasmohan Bajaj
Staff Physician
Hunter Holmes Mcguire Veteran Affairs Medical Center