Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03856359 | Trial of Rifaximin in Probable Alzheimer's Disease | PHASE2 | COMPLETED | 10 | — | — | Apr 9, 2019 | Nov 19, 2020 | Dec 17, 2021 | 1 | United States |
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. ...