Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rifaximin 550 milligrams · 1 trial · 1 indication
Collected at every visit and follow-up phone visits. A rare side effect of Rifaximin is diarrhea caused by clostridium difficile. This is a very serious form of diarrhea that can be fatal if not treated. The investigators will be following the patients closely during treatment and for 2 months following treatment to see if the patient has any signs or symptoms of this diarrhea. If a patient does develop clostridium difficile diarrhea, they will be promptly treated.
Change in Alzheimer's Disease Assessment Scale - Cognition test with 11 tasks (ADAS Cog 11) scores following 3 months of oral Rifaximin. Scores range from minimum 0 - maximum 70. Higher scores mean worse outcome.
| Arm | Type | Description |
|---|---|---|
| Rifaximin | EXPERIMENTAL | rifaximin 550 milligrams (mg) orally twice daily for 3 months |
| Name | Type | Description |
|---|---|---|
| Rifaximin 550 milligrams (MG) | DRUG | Rifaximin (Xifaxan, Salix Pharmaceuticals, Bridgewater, N.J.) (See Package Insert) is a drug that is approved by the FDA for use in humans for the treatment of Hepatic Encephalopathy, Traveler's Diarrhea and Irritable Bowel Syndrome. It is commercially available. It will be used in accordance with approved labeling as pertains to dosage and administration for Hepatic Encephalopathy, contraindications and warnings. However, it will be used investigationally in this trial as rifaximin is not FDA approved for the treatment of Alzheimer's Disease. |
Inclusion Criteria: * · 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. ...
Top 20 of 24 competitors
Rifaximin 550 milligrams is an investigational small molecule being studied for the treatment of Alzheimer's Disease. It is being developed by Bausch + Lomb Corporation (NYSE: BLCO). The drug is currently in Phase 2 clinical development, though it is not yet approved for this use.
Rifaximin 550 milligrams is a small molecule antibiotic that targets the gut microbiome. By modulating gut bacteria, it may influence the gut-brain axis, which is hypothesized to play a role in Alzheimer's Disease. However, the exact mechanism in this context is still under investigation.
Rifaximin 550 milligrams is being developed by Bausch + Lomb Corporation, which trades on the New York Stock Exchange under the ticker symbol BLCO. The company is conducting clinical research to evaluate the drug's potential in Alzheimer's Disease.
Rifaximin 550 milligrams is in Phase 2 clinical development for Alzheimer's Disease. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 trial has been completed to assess its safety and efficacy in this patient population.
Rifaximin 550 milligrams has one completed Phase 2 trial, identified by the National Clinical Trial number NCT03856359. The trial, titled 'Trial of Rifaximin in Probable Alzheimer's Disease,' enrolled 10 participants in the United States. It was an uncontrolled, open-label study that included a biomarker-selected patient population.
Rifaximin 550 milligrams is a specific dosage form of the drug rifaximin, which is also marketed under the brand name Xifaxan for other indications. However, in the context of Alzheimer's Disease research, it is being investigated as an investigational therapy and is not approved for this condition.