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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000046682 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | 1. Patients with dementia, mild cognitive impairment, or subjective cognitive impairment
2. Healthy volunteers |
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Classification by specialty |
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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 | |
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Blocking | |
Concealment |
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Eligibility | ||||
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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. |
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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. |
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Target sample size | 200 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053251 |
Research Plan | |
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Research case data specifications | |
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Research case data | |
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