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RIDE

RecruitingPhase 1 / PHASE2

Rifaximin SSD in Dementia Trial

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

Lead sponsor

Jasmohan Bajaj

Asset

Rifaximin SSD

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia

Key I/E criteria

•Multiple dementia etiologies•Study partner/caregiver required

Primary endpoints

•Stool and serum short-chain fatty acid levels•Bile acids in stool and serum

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID1817324

NCT IDNCT06718686

Timeline

Milestones

Study first posted2024-12-05actual

Study start2024-12-30actual

Last update posted2026-04-03actual

Primary completion2027-10-30estimated

Study completion2027-12-30estimated

Assets

Drug assets

Rifaximin SSD

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementia

Eligibility

Who can enroll

Minimum age65 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Caregiver / quality of life

Global cognition

Function / daily living

Executive function / language

Amyloid biomarkers

Safety / tolerability / PK

Global cognition

2 endpoints

Secondary/protocol endpoint

MMSE

Time frame:10 weeks

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Secondary/protocol endpoint

Clinical Dementia Rating - Sum of Boxes (CDR-SB)

Time frame:10 weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Executive function / language

1 endpoint

Secondary/protocol endpoint

EncephalApp Stroop performance

Time frame:10 weeks

change from baseline, improvement

Function / daily living

2 endpoints

Secondary/protocol endpoint

Katz Index of Independence in Activity of Daily Living (ADL)

Time frame:10 weeks

change from baseline, improvement

Secondary/protocol endpoint

Lawton-Brody Instrumental Activities of Daily Living (IADL)

Time frame:10 weeks

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Change in dementia biomarkers

Time frame:10 weeks

change from baseline, improvement

Caregiver / quality of life

3 endpoints

Secondary/protocol endpoint

Zarit Burden Interview short form

Time frame:10 weeks

change from baseline, improvement

Secondary/protocol endpoint

Sickness Impact profile

Time frame:10 weeks

change from baseline, improvement

Secondary/protocol endpoint

PROMIS-29

Time frame:10 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Safety

Time frame:10 weeks

event count, event

Other (unclassified)

6 endpoints

Primary/protocol endpoint/low confidence

Change in stool and serum short-chain fatty acid levels

Time frame:10 weeks

change from baseline, improvement

Primary/protocol endpoint/low confidence

Change in bile acids in stool and serum

Time frame:10 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Systemic inflammatory change

Time frame:10 weeks

descriptive

Secondary/protocol endpoint/low confidence

Stool microbiome composition

Time frame:10 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Cognitive testing using Psychometric Hepatic Encephalopathy Score

Time frame:10 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Critical flicker fusion analysis

Time frame:10 weeks

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.