Gut Microbiota and Alzheimer's Diseases
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
November 28, 2018
CompletedFirst Posted
Study publicly available on registry
February 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedApril 19, 2021
April 1, 2021
4.9 years
November 28, 2018
April 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Gut microbiota
Through study completion, an average of 4 year
Oral microbiota
Through study completion, an average of 4 year
Cognitive function by Mini-mental State Examination (MMSE)
through study completion, an average of 4 year
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- aged 60 and older
You may not qualify if:
- with other acute gastrointestinal diseases
- with other severe neuropsychiatric disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072, China
Biospecimen
Fecal sample collection
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yuan Shen, MD, PhD
Shanghai 10th People's Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief of Psychiatry Department
Study Record Dates
First Submitted
November 28, 2018
First Posted
February 1, 2019
Study Start
February 1, 2018
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
April 19, 2021
Record last verified: 2021-04