UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046682 |
|---|---|
| Receipt number | R000053251 |
| Scientific Title | Elucidation of the mechanism of visual hallucinations in dementia and development of a new test |
| Date of disclosure of the study information | 2022/01/24 |
| Last modified on | 2022/01/21 17:01:42 |
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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
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
m.kitazawa@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053251
