A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease

Study Overview
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Brief Summary
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This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding Alzheimer's disease.

Detailed Description
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The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding Alzheimer's disease.

Official Title
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A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Alzheimer's Disease

Conditions
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Alzheimer Disease, Alzheimer Disease 1, Alzheimer Disease 2, Alzheimer Disease 3, Alzheimer Disease 4, Alzheimer Disease 5, Alzheimer Disease 6, Alzheimer Disease 7, Alzheimer Disease 8, Alzheimer Disease 9, Late-Onset, Alzheimer Disease 10, Alzheimer Disease 11, Alzheimer Disease 12, Alzheimer Disease 13, Alzheimer Disease 14, Alzheimer Disease 15, Alzheimer Disease 16, Alzheimer Disease 17, Alzheimer Disease 18, Alzheimer Disease 19, Alzheimer Disease, Early Onset, Alzheimer Disease, Late Onset, Alzheimer Disease Focal

Intervention / Treatment
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* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study Male or female patients age 18 and older Diagnosis of Alzheimer's disease or dementia by a physician Mini Mental Status Exam score less than 26 Exclusion Criteria: Refusal to sign informed consent form Treatment with antibiotics within 2 weeks prior to screening Treatment with probiotics within 2 weeks prior to screening History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alzheimer's disease patients<br>Patients who have been diagnosed with Alzheimer's disease | Other: No Intervention<br>* There is no intervention for this study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Alzheimer's Disease via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be correlated to Alzheimer's disease state | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiome