Rifaximin SSD in Dementia Trial

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Jasmohan Bajaj
Study ID
NCT06718686
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • Dementia Alzheimer Type
  • Dementia Associated With Cerebrovascular Disease

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rifaximin SSD 40 mg IR tablet — DRUG
    Drug therapy vs placebo
  • Placebo — DRUG
    Placebo drug

Study Details

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.

Key Dates

Start date
Dec 30, 2024
Status verified
Apr 2026
Primary completion
Oct 30, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: Placebo
    Patients will be given placebo and actual drug sequentially with the order hidden
  • Experimental: Rifaximin SSD 40mg IR BID
    Patients will be given placebo and actual drug sequentially with the order hidden

Primary Outcome Measure

Change in stool and serum short-chain fatty acid levels [ Time Frame: 10 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Richmond VA Medical CenterRichmondVirginia23249
Haley Obolewicz, RN
804-675-5000

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