UMIN-CTR Clinical Trial

Basic information
Public title	Elucidation of the mechanism of visual hallucinations in dementia and development of a new test
Acronym	Elucidation of the mechanism of visual hallucinations in dementia and development of a new test
Scientific Title	Elucidation of the mechanism of visual hallucinations in dementia and development of a new test
Scientific Title:Acronym	Elucidation of the mechanism of visual hallucinations in dementia and development of a new test
Region	Japan

Condition
Condition	1. Patients with dementia, mild cognitive impairment, or subjective cognitive impairment 2. Healthy volunteers
Classification by specialty	Psychiatry Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to develop an algorithm to estimate the presence and severity of dementia, mild cognitive impairment, and subjective cognitive impairment using data from the Pareidolia test, and to extract features of the diseases and build a face detection model to emulate visual hallucination.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Features extracted from the results of the pareidolia test using machine learning.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who meet the following 1), 2), and 3) criteria will be included in the prospective observation, and patients who meet the following 4) criteria will be included in the retrospective observation. 1) Out/in-patients at study sites diagnosed as dementia, mild cognitive impairment, or subjective cognitive impairment, or healthy volunteers who are offered participation to the study through web site. 2) 20 years old or older 3) Decisionally not impaired judged by treating physician. If judged as decisionally impaired, patients' guardians can give consent 4) Patients who underwent pareidolia testing for clinical necessity at study sites between June 1, 2012 and November 30, 2020, and who were20 years old or older.
Key exclusion criteria	1) Patients whose illness can be exacerbated by interview of the study. 3) Those who are considered to be ineligible by the PI or investigators.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Taishiro Middle name Last name Kishimoto
Organization	Keio University School of Medicine
Division name	Hills Joint Research Laboratory for Future Preventive Medicine and Wellnes
Zip code	106-0032
Address	Roppongi Hills North Tower 7F, 6-2-31 Roppongi, minato-ku, Tokyo, Japan
TEL	03-5786-0006
Email	tkishimoto@keio.jp

Public contact
Name of contact person	1st name Momoko Middle name Last name Kitazawa
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Zip code	160-8582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
TEL	03-5363-3492
Homepage URL	http://psy.keiomed.jp/research/34.html_http://psy.keiomed.jp/research/34.html
Email	m.kitazawa@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	National Institute of Informatics Tokyo Dental College Ichikawa General Hospital Tsutsuji Mental Hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Clinical and Translational Research Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo, JAPAN
Tel	03-3353-1211
Email	med-rinri-jimu@adst.keio.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 24 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2021 Year 05 Month 11 Day
Date of IRB	2021 Year 06 Month 28 Day
Anticipated trial start date	2021 Year 07 Month 24 Day
Last follow-up date	2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

This study will use both newly collected pareidolia test data from prospective observation and existing pareidolia test data collected from retrospective observation. Consent forms will be obtained for subjects undergoing prospective observation, and opt-out will be provided for use of data under retrospective observation. For healthy volunteers, the Mini-Mental State Examination (MMSE) will be administered in conjunction with the Pareidolia test to confirm that they do not have DSM-5 dementia or mild cognitive impairment. The observation items for the prospective and retrospective observations are as follows, A: Background factors and information on cognitive function Background information on diagnosis, gender, severity, and duration of illness will be obtained from medical records. The MMSE will be administered to healthy volunteers. B: Results of pareidolia test The number of correct answers, the number of pareidolia, the number of oversights, the illusory response rate, and the location of the illustration where the hallucination occurred.

Management information
Registered date	2022 Year 01 Month 20 Day
Last modified on	2022 Year 01 Month 21 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053251

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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