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RECRUITINGPHASE1/PHASE2

Rifaximin SSD in Dementia Trial

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

NCT06718686•Jasmohan Bajaj

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

Age

65 - No limit years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

Locations (1)

Richmond VA Medical Center

Richmond, Virginia, United States

Key Dates

Start Date

December 30, 2024

Primary Completion Date

December 1, 2025

Completion Date

May 1, 2026

Last Updated

December 31, 2024

Enrollment

ESTIMATED participants

Conditions

Dementia Alzheimer TypeDementia Associated With Cerebrovascular Disease

Interventions

Rifaximin SSD 40 mg IR tablet

DRUG

Placebo

DRUG

Contacts

Jasmohan S Bajaj, MD

CONTACT

804-675-5802 jasmohan.bajaj@vcuhealth.org

Haley Obolewicz, RN

CONTACT

804-675-5705 haley.obolewicz@va.gov

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 31, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Rifaximin SSD in Dementia Trial

Inclusion Criteria

Exclusion Criteria

Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus for Alzheimer Disease (AD)

Effectiveness of Strength-based Intervention for Elderly With Dementia Living in the Community

Effects on the Olfactory Epithelium and the Olfactory Nerve From Exposure to Diesel Exhaust