Tokyo, March 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060727) titled 'Identification of oral bacteria involved in mild cognitive impairment and research on methods for controlling them' on March 1.
Study Type:
Observational
Primary Sponsor:
Institute - Yamaguchi University
Condition:
Condition - Mild cognitive impairment
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The objective of this study is to identify oral bacteria associated with the promotion of Alzheimer's disease onset, one of the pathophysiological hypotheses involving brain inflammation.
Basic objectives2 - Bio-availability
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - (1) Patient group: 1) Diagnosed with mild cognitive impairment according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) by the American Psychiatric Association, and 2) scored 25 or below on the Montreal Cognitive Assessment (MoCA)-J, which evaluates multiple cognitive functions, and 20 or above on the Mini Mental State Examination (MMSE)-J.
(2) Control group: Outpatients of the Department of Oral and Maxillofacial Surgery at our hospital with normal cognitive function (MoCA score 26 points or more, MMSE-J score 28 points or more).
Key exclusion criteria - 1) History of head trauma, brain tumors, or neurodegenerative diseases.
2) For the patient group, outpatient primary care physicians have already prescribed anti-dementia drugs, steroids, or antibiotics that affect oral bacteria.
Target Size - 225
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2019 Year 12 Month 20 Day
Date of IRB - 2020 Year 07 Month 31 Day
Anticipated trial start date - 2020 Year 08 Month 01 Day
Last follow-up date - 2028 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069471
Disclaimer: Curated by HT Syndication.
