Gut Microbiota and Alzheimer's Diseases

Study Overview
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Brief Summary
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The investigator will perform clinical studies to test a hypothesis that participants who have Alzheimer's disease will have different gut/oral microbiota profile as compared to the participants who do not have Alzheimer's disease. The investigators will also check the microbiome of their partners in this study. The investigators plan to perform the studies in 150 participants in Shanghai Tenth's People's Hospital and also in the houses in Shanghai city. Investigators will also measure the beta-amyloid in the feces of the participants. Finally, the investigators will determine cognitive function in these participants.

Detailed Description
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Studies have shown that gut/oral microbiome and beta-amyloid in body may have a significant impact on the behavior and brain pathology consistent with Alzheimer's disease (AD) neuropathogenesis. The objective of this study is to assess whether the gut/oral microbiome and feces beta-amyloid of AD patients are different from those of the participants without AD and their partners. The investigators plan to recruit 150 subjects, including three groups of normal elders, AD patients and the partners of the AD patients. The cognitive function will be assessed and the feces and oral samples will be collected to determine whether there are differences or correlations.

Official Title
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Gut Microbiota and Alzheimer's Diseases

Conditions
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Alzheimer Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 60 and older Exclusion Criteria: with other acute gastrointestinal diseases with other severe neuropsychiatric disorders

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AD patients<br>Participants who are diagnosed with AD. | |
| Partners of the AD patients<br>Partners of AD patients who live together with the AD patients. | |
| Elderly participants with normal cognition<br>Community dwelling elderly with normal cognition and with AD. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut beta-amyloid 42 | Gut amyloid-beta 42 will be determined by digital ELISA, traditional ELISA and western blot. | Through study completion, an average of 4 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gut microbiota | We will use DNA sequencing to define the profile of gut microbiota. | Through study completion, an average of 4 year | 
| Oral microbiota | We will use DNA sequencing to define the profile of gut microbiota. | Through study completion, an average of 4 year | 
| Cognitive function by Mini-mental State Examination (MMSE) | We will assess the cognitive function in the participants using MMSE to promote the diagnosis of AD in these participants. The sum of MMSE ranges from 0 (worse) to 30 (better). | through study completion, an average of 4 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gut Microbiota, Alzheimer's Diseases