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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
Drug therapy vs placebo
Placebo drug
Richmond VA Medical Center
Richmond, Virginia, United States
RECRUITINGChange 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
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
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
Stool microbiome composition
16SrRNA microbiome composition and diversity change in placebo vs Rifaximin SSD phase
Time frame: 10 weeks
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
MMSE
Change in MMSE between the 2 phases
Time frame: 10 weeks
Cognitive testing using Psychometric Hepatic Encephalopathy Score
Change in PHES in placebo vs rifaximin SSD phase
Time frame: 10 weeks
Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Change in CDR-SB in placebo vs Rifaximin SSD phase
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Time frame: 10 weeks
EncephalApp Stroop performance
Change in off time and on time in seconds between placebo and rifaximin SSD phases
Time frame: 10 weeks
Critical flicker fusion analysis
change in threshold to see CFF fusion in rifaximin SSD vs placebo phases
Time frame: 10 weeks
Katz Index of Independence in Activity of Daily Living (ADL)
change in the score above judged by caregivers in placebo vs Rifaximin SSD phase
Time frame: 10 weeks
Lawton-Brody Instrumental Activities of Daily Living (IADL)
Change in instrument score above by caregivers in rifaximin SSD vs placebo phase
Time frame: 10 weeks
Zarit Burden Interview short form
Change in instrument score above by caregivers in rifaximin SSD vs placebo phase
Time frame: 10 weeks
Sickness Impact profile
change in score of the QOL instrument above in placebo vs rifaximin SSD phases
Time frame: 10 weeks
PROMIS-29
change in score of the QOL instrument above in placebo vs rifaximin SSD phases
Time frame: 10 weeks
Safety
Serious adverse event rates in placebo versus rifaximin SSD phases
Time frame: 10 weeks