NCT06718686

Rifaximin SSD in Dementia Trial

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Jasmohan Bajaj · Federal
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dementia Alzheimer Type
• Dementia Associated With Cerebrovascular Disease

Interventions

Type	Name	Description
DRUG	Rifaximin SSD 40 mg IR tablet	Drug therapy vs placebo
DRUG	Placebo	Placebo drug

Timeline

• Start date: 2024-12-30
• Primary completion: 2027-10-30
• Completion: 2027-12-30
• First posted: 2024-12-05
• Last updated: 2026-04-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study