Health TrialsbyHealthPanel

Rifaximin SSD in Dementia Trial

ConditionsDementia Alzheimer TypeDementia Associated With Cerebrovascular Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age65+
SponsorJasmohan Bajaj

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • Rifaximin SSD 40 mg IR tablet

    Drug

    Drug therapy vs placebo

  • Placebo

    Drug

    Placebo drug

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: Rifaximin SSD 40mg IR BIDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in stool and serum short-chain fatty acid levels

Change in SCFA in stool and serum in rifaximin SSD phase vs placebo phase

Time frame
10 weeks
2

Change in bile acids in stool and serum

Change in bile acids in stool and serum in rifaximin SSD phase vs placebo phase

Time frame
10 weeks

Secondary outcomes

1

Systemic inflammatory change

serum lipopolysaccharide-binding protein (LBP), inflammatory cytokines (IL-6, TNF-α, IL-10, IL-1β) in placebo phase vs Rifaximin SSD phase

Time frame
10 weeks
2

Stool microbiome composition

16SrRNA microbiome composition and diversity change in placebo vs Rifaximin SSD phase

Time frame
10 weeks
3

Change in dementia biomarkers

Plasma concentrations of Aβ42 and Aβ40 to calculate amyloid-β (Aβ)42/40 ratio and plasma concentration of phospho-tau (p-tau)181 in placebo vs Rifaximin SSD phase

Time frame
10 weeks
4

MMSE

Change in MMSE between the 2 phases

Time frame
10 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jasmohan Bajaj

Lead sponsor

Hunter Holmes Mcguire Veteran Affairs Medical Center

Sponsor institution

Bausch Health Americas, Inc.

Collaborator

Source ClinicalTrials.gov
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