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| Name | Class |
|---|---|
| Bausch Health Americas, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Patients will be given placebo and actual drug sequentially with the order hidden |
|
| Rifaximin SSD 40mg IR BID | Experimental | Patients will be given placebo and actual drug sequentially with the order hidden |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rifaximin SSD 40 mg IR tablet | Drug | Drug therapy vs placebo |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in stool and serum short-chain fatty acid levels | Change in SCFA in stool and serum in rifaximin SSD phase vs placebo phase | 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 | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 10 weeks |
| Stool microbiome composition |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jasmohan S Bajaj, MD | Contact | 804-675-5802 | jasmohan.bajaj@vcuhealth.org | |
| Haley Obolewicz, RN | Contact | 804-675-5705 | haley.obolewicz@va.gov |
| Name | Affiliation | Role |
|---|---|---|
| Jasmohan Bajaj | Richmond VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Richmond VA Medical Center | Recruiting | Richmond | Virginia | 23249 | United States |
Not IRB approved to do so
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D015140 | Dementia, Vascular |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| Placebo |
| Drug |
Placebo drug |
|
16SrRNA microbiome composition and diversity change in placebo vs Rifaximin SSD phase
| 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 | 10 weeks |
| MMSE | Change in MMSE between the 2 phases | 10 weeks |
| Cognitive testing using Psychometric Hepatic Encephalopathy Score | Change in PHES in placebo vs rifaximin SSD phase | 10 weeks |
| Clinical Dementia Rating - Sum of Boxes (CDR-SB) | Change in CDR-SB in placebo vs Rifaximin SSD phase | 10 weeks |
| EncephalApp Stroop performance | Change in off time and on time in seconds between placebo and rifaximin SSD phases | 10 weeks |
| Critical flicker fusion analysis | change in threshold to see CFF fusion in rifaximin SSD vs placebo phases | 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 | 10 weeks |
| Lawton-Brody Instrumental Activities of Daily Living (IADL) | Change in instrument score above by caregivers in rifaximin SSD vs placebo phase | 10 weeks |
| Zarit Burden Interview short form | Change in instrument score above by caregivers in rifaximin SSD vs placebo phase | 10 weeks |
| Sickness Impact profile | change in score of the QOL instrument above in placebo vs rifaximin SSD phases | 10 weeks |
| PROMIS-29 | change in score of the QOL instrument above in placebo vs rifaximin SSD phases | 10 weeks |
| Safety | Serious adverse event rates in placebo versus rifaximin SSD phases | 10 weeks |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D002537 | Intracranial Arteriosclerosis |
| D020765 | Intracranial Arterial Diseases |
| D056784 | Leukoencephalopathies |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |