Status:
COMPLETED
Trial of Rifaximin in Probable Alzheimer's Disease
Lead Sponsor:
Duke University
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
Brief Summary
This study aims to improve cognition and function in patients with Alzheimer's Disease (AD) by administering the oral antibiotic, Rifaximin. Rifaximin is a virtually non-absorbed antibiotic with the ...
Detailed Description
This study aims to improve cognition and function in patients with Alzheimer's Disease (AD) by administering the oral antibiotic, rifaximin. Rifaximin is a virtually non-absorbed antibiotic with the u...
Eligibility Criteria
Inclusion
- · Probable Alzheimer's Disease (National Institute of Neurological Disorders and Stroke (NINDS) criteria), mild to moderate severity
- Ages 55-85; both genders
- Mini Mental State Exam (MMSE) scores 10-23
- Willing and able to comply with all scheduled clinic visits.
- Stable medical health
- Has a family or professional caregiver who has regular contact with subject
- Ability to consent or legal guardian who can consent
- Living at home or in a facility
- On no AD therapies or on stable (2 months) concurrent AD therapies
Exclusion
- Past history of C diff infection
- Assessment, laboratory examination, physical examination or any other medical condition or circumstance making the volunteer unsuitable for participation in the study in the judgment of the study clinicians
- Allergy to Rifaximin
- Antibiotic use or hospitalization in the last 6 months
- Are taking medications that interact with rifaximin and/or pose a safety risk in the judgment of the PI
- Clinically significant abnormal hepatic or renal function
- Uncorrected thyroid or B12 abnormalities
- Participation in another investigational drug trial in the past 30 days
- History of febrile illness within 5 days prior to the study period
- Known Hyperammonemia caused by:
- Valproic acid Chemotherapy Lung transplant Bariatric surgery Ureterosigmoidoscopy Hyperalimentation Urinary tract infection Errors of metabolism: urea cycle, enzyme deficiencies, organic acidemias, fatty acid oxidation, amino acid transport defects
Key Trial Info
Start Date :
April 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03856359
Start Date
April 9 2019
End Date
November 19 2020
Last Update
December 17 2021
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710