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Anti-biotic
Rifaximin for Dementia (RIDE Trial)
Richmond, VA
Phase 1 & 2
Recruiting
Research Sponsored by Jasmohan Bajaj
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Probable Alzheimer's Disease (AD) or Vascular Dementia (VaD) mild or moderate based on Clinical Dementia Rating Scale
Males and Females Age ≥ 65 years
Must not have
Antibiotic use in the prior 6 months
Unstable, severe, or poorly controlled medical conditions evident from physical examination or clinical history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 weeks
Summary
This trial is testing a new form of rifaximin, an antibiotic that is not absorbed by the body, to see if it can help improve the gut microbes of patients with dementia.
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Who is the study for?
This trial is for individuals aged 65 or older with mild to moderate Alzheimer's Disease or Vascular Dementia. Participants must be able to consent (or have a legal guardian who can), speak English, and live in the community with a caregiver available.Check my eligibility
What is being tested?
The study tests Rifaximin SSD, a new non-absorbable antibiotic formulation, against a placebo to see if it positively affects gut microbes in dementia patients.See study design
What are the potential side effects?
While specific side effects are not listed here, antibiotics like Rifaximin may cause digestive issues such as bloating or gas, and changes in bowel habits.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with mild or moderate Alzheimer's or Vascular Dementia.
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I am 65 years old or older.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not taken antibiotics in the last 6 months.
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Select...
I do not have any severe or poorly controlled health conditions.
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Select...
My dementia is not caused by Alzheimer's or vascular issues.
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I need antipsychotic medication for my severe agitation or aggression.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in bile acids in stool and serum
Change in stool and serum short-chain fatty acid levels
Secondary study objectives
Change in dementia biomarkers
Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Cognitive testing using Psychometric Hepatic Encephalopathy Score
+11 moreSide effects data
From 2015 Phase 3 trial • 40 Patients • NCT0312419936%
Diarrhea
25%
Metallic Taste
14%
Headache
14%
Nausea
3%
abdominal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rifaximin
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Rifaximin SSD 40mg IR BIDExperimental Treatment1 Intervention
Patients will be given placebo and actual drug sequentially with the order hidden
Group II: PlaceboPlacebo Group1 Intervention
Patients will be given placebo and actual drug sequentially with the order hidden
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Rifaximin SSD 40 mg IR tablet
2013
Completed Phase 2
~420
Find a Location
Closest Location:Richmond VA Medical Center· Richmond, VA· 395 miles
Who is running the clinical trial?
Jasmohan BajajLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
Bausch Health Companies, INC.UNKNOWN
1 Previous Clinical Trials
70 Total Patients Enrolled
Bausch Health Americas, Inc.Industry Sponsor
264 Previous Clinical Trials
81,986 Total Patients Enrolled