rifaximin 550 milligrams (mg) orally twice daily for 3 months

Alzheimer's Disease

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.

Rifaximin 550 milligrams (MG)

Duke University Medical Center

Trial of Rifaximin in Probable Alzheimer's Disease

Pilot, Single Center, Open, Trial of Rifaximin in Probable Alzheimer's Disease

Done at Baseline, 3 month and 5 month visits. ADAS-Cog is a widely used cognitive endpoint in AD clinical trials and changes on this scale, over time, are considered clinically meaningful. ADAS-11 range is 0-70 with higher scores indicating worse performance. Errors from 11 items are added to generate the total score.

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.

Done at Baseline, 3 month and 5 month visits. When brain tissue is damaged, it releases substances (serum neuronal markers) into the blood, such as Neurofilament Light. The investigators will be looking for the amount of these serum neuronal markers to decrease after three months of Rifaximin treatment, indicating less brain tissue damage.

The investigators will be looking for changes in the amounts of the following pro-inflammatory markers:
Interleukin (IL) 1 beta, IL 2, IL 4, IL 5, IL 6, IL 8, IL 10, IL 13, Tumor necrosis factor - alpha

The study drug, Rifaximin, is an antibiotic. It changes the mixture of bacteria in the colon. The investigators will analyze the types of bacteria that are in the patient's colon. The microbiome variables the investigators will use standard FDR correction to examine nominal significance of change from baseline. The investigators will be assessing the Escherichia, shigella, pseudomonas, bacteroides, eubacterium and Faecalibacterium.

Assessed at every visit. The patients will be followed closely to see if they are tolerating the drug, Rifaximin. The of the number of side effects would indicate that the patient may not be tolerating the drug. Most of these side effects are minor and include headache, nausea, vomiting, tiredness. A potentially fatal side effect would be the development of clostridium difficile diarrhea. 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 from baseline global cognitive scores at month 3). Global cognitive performance will be assessed by a psychometrician using the (MMSE). It is a brief cognitive questionnaire with a maximum score of 30 points. MMSE range is 0-30 with lower scores indicating worse performance. The number of correct answers is added to generate the total score.

Safety will be measured through adverse events as reported by the subjects

Clinically significant deviations from the baseline on CBC will be considered an AE and clinically significant

Clinically significant deviations from baseline to month 3 in blood pressure.

Clinically significant deviations from baseline to month 3 in pulse.

Clinically significant deviations from the baseline on Chemistry values as defined as Creatine, blood urine nitrogen, electrolytes and sodium potassium chloride results will be considered an AE.

Clinically significant deviations from the baseline on LFT will be considered an AE.

Clinically significant deviations from the baseline on clinically significant and newly emergent C Difficile infection will be considered.

glutaminase/nekróza

Trial of Rifaximin in Probable Alzheimer's Disease

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