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Clinical Trials/NCT03827733
NCT03827733
Unknown
Not Applicable

Gut Microbiota and Alzheimer's Diseases

Shanghai 10th People's Hospital1 site in 1 country200 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Shanghai 10th People's Hospital
Enrollment
200
Locations
1
Primary Endpoint
Gut beta-amyloid 42
Last Updated
5 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
December 31, 2022
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Shanghai 10th People's Hospital
Responsible Party
Principal Investigator
Principal Investigator

Yuan Shen, MD, PhD

Chief of Psychiatry Department

Shanghai 10th People's Hospital

Eligibility Criteria

Inclusion Criteria

  • aged 60 and older

Exclusion Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

  • 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)
  • Gut microbiota(Through study completion, an average of 4 year)

Study Sites (1)

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