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Gut Microbiota and Alzheimer's Diseases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03827733
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : April 19, 2021
Information provided by (Responsible Party):
Yuan Shen, MD, PhD, Shanghai 10th People's Hospital

Brief Summary:
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.

Condition or disease
Alzheimer Disease

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Gut Microbiota and Alzheimer's Diseases
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

AD patients
Participants who are diagnosed with AD.
Partners of the AD patients
Partners of AD patients who live together with the AD patients.
Elderly participants with normal cognition
Community dwelling elderly with normal cognition and with AD.

Primary Outcome Measures :
  1. Gut beta-amyloid 42 [ Time Frame: Through study completion, an average of 4 year ]
    Gut amyloid-beta 42 will be determined by digital ELISA, traditional ELISA and western blot.

Secondary Outcome Measures :
  1. Gut microbiota [ Time Frame: Through study completion, an average of 4 year ]
    We will use DNA sequencing to define the profile of gut microbiota.

  2. Oral microbiota [ Time Frame: Through study completion, an average of 4 year ]
    We will use DNA sequencing to define the profile of gut microbiota.

  3. Cognitive function by Mini-mental State Examination (MMSE) [ Time Frame: through study completion, an average of 4 year ]
    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).

Biospecimen Retention:   Samples Without DNA
Fecal sample collection

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Elderly participants with normal congition will be collected from community. Alzheimer's disease participants and their spouse will be collected from Shanghai Tenth People's Hopital.

Inclusion Criteria:

  • aged 60 and older

Exclusion Criteria:

  • with other acute gastrointestinal diseases
  • with other severe neuropsychiatric disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03827733

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Contact: Yuan Shen, MD, PhD 02166303649
Contact: Zhongyong Shi, MD 18701915271

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China, Shanghai
Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Yanxia Guo, M.D.    021-65982875   
Sponsors and Collaborators
Shanghai 10th People's Hospital
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Principal Investigator: Yuan Shen, MD, PhD Shanghai 10th People's Hospital
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Responsible Party: Yuan Shen, MD, PhD, Chief of Psychiatry Department, Shanghai 10th People's Hospital Identifier: NCT03827733    
Other Study ID Numbers: dsyy004
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: April 19, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yuan Shen, MD, PhD, Shanghai 10th People's Hospital:
Gut Microbiota
Alzheimer's Diseases
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders