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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.
 
ClinicalTrials.gov Identifier: NCT03827733
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
Massachusetts General Hospital
Information provided by (Responsible Party):
Yuan Shen, MD, PhD, Shanghai 10th People's Hospital

Brief Summary:
The investigator will perform clinical studies to test the hypothsis that participants who had Alzhemer's disease will have different gut microbiota in the feaces as compared to participants who did not have Alzhemer's disease, as well as compared to their spouse.The investigators plan to perfoem the studies in 150 participants in Shanghai Tenth's People's Hospital.

Condition or disease
Alzheimer Disease

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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, 2019
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
AD patients
Participants who are diagnosed with AD.
Spouse of the AD patients
Spouse of AD patients, and live together with AD patients.
Elderly participants with normal congition
Community dwelling elderly with normal cognition .



Primary Outcome Measures :
  1. Gut amyloid-beta 42 [ Time Frame: within 1 year after the participants was assessed ]
    Gut amyloid-beta 42 will be determined by elisa, BCA, western blot,.etc.


Biospecimen Retention:   Samples Without DNA
Fecal sample collection


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT03827733


Contacts
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Contact: Yuan Shen, MD, PhD 02166303649 kmshy@tongji.edu.cn
Contact: Zhongyong Shi, MD 18701915271 szy0721@126.com

Locations
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China, Shanghai
Shanghai Tenth People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Yanxia Guo, M.D.    021-65982875    guoyx_2000@tongji.edu.cn   
Sponsors and Collaborators
Shanghai 10th People's Hospital
Massachusetts General Hospital
Investigators
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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
ClinicalTrials.gov Identifier: NCT03827733    
Other Study ID Numbers: dsyy004
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: April 2019
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
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders