UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055033 |
|---|---|
| Receipt number | R000062354 |
| Scientific Title | A cross-sectional study on the proportion of treatable dementia patients in our outpatient clinic |
| Date of disclosure of the study information | 2024/07/22 |
| Last modified on | 2024/07/31 14:37:27 |
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Basic information
Public title
A cross-sectional study on the proportion of treatable dementia patients in our outpatient clinic
Acronym
A cross-sectional study on the proportion of treatable dementia patients in our outpatient clinic
Scientific Title
A cross-sectional study on the proportion of treatable dementia patients in our outpatient clinic
Scientific Title:Acronym
A cross-sectional study on the proportion of treatable dementia patients in our outpatient clinic
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Medicine in general | Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Dementia is not a single disease, but a general term for diseases that cause cognitive impairment. Some diseases that cause cognitive impairment are treatable, and these are known as treatable dementias. However, there are currently no reports on the prevalence of treatable dementia in dementia. We aim to determine the prevalence and breakdown of treatable dementia in patients with forgetfulness, and to explore the extent to which therapeutic intervention can improve cognitive function in treatable dementia.
Basic objectives2
Others
Basic objectives -Others
This is an epidemiological study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of treatable dementia patients who visited the hospital with forgetfulness as their main complaint
Key secondary outcomes
Whether or not the dementia is treatable is the independent variable, and the dependent variable is the MMSE score 3 months after diagnosis minus the MMSE score at diagnosis. Is there a correlation between the mean of the dependent variable and the independent variable?
Whether or not the dementia is treatable is the independent variable, and the dependent variable is the FAB score 3 months after diagnosis minus the FAB score at diagnosis. Is there a correlation between the mean of the dependent variable and the independent variable?
Whether or not the dementia is treatable is the independent variable, and the dependent variable is the TMT-A score 3 months after diagnosis minus the TMT-A score at diagnosis. Is there a correlation between the mean of the dependent variable and the independent variable?
Whether or not the dementia is treatable is the independent variable, and the dependent variable is the TMT-B score 3 months after diagnosis minus the TMT-B score at diagnosis. Is there a correlation between the mean of the dependent variable and the independent variable?
Whether or not the dementia is treatable is the independent variable, and the dependent variable is the Rey complex figure score 3 months after diagnosis minus the Rey complex figure score at diagnosis. Is there a correlation between the mean of the dependent variable and the independent variable?
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who visit Musashino Hospital's forgetfulness outpatient clinic with the main complaint of cognitive impairment.
2. Patients who are able to cooperate with physical examinations, neuropsychological tests, and imaging tests.
3. Patients or their representatives are able to communicate in Japanese.
Key exclusion criteria
Those who did not give consent to participate in this study.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | MAKISHI |
Organization
Musashino Hospital, Koyukai Medical Corporation
Division name
Department of Neurology
Zip code
184-0031
Address
1-23-10 Ogawa-Higashimachi Kodaira city Tokyo
TEL
042-313-5520
nmakishi.ryk@gmail.com
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | MAKISHI |
Organization
Medical Corporation Koyukai Musashino Hospital
Division name
Department of Neurology
Zip code
184-0031
Address
1-23-10 Ogawa-Higashimachi Kodaira city Tokyo
TEL
042-313-5520
Homepage URL
nmakishi.ryk@gmail.com
Sponsor or person
Institute
Musashino Hospital, Koyukai Medical Corporation
Institute
Department
Personal name
Naoko MAKISHI
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Musashino Hospital, Koyukai Medical Corporation
Address
1-23-10 Ogawa-higashimachi Kodaiira city, Tokyo
Tel
042-313-5520
musashino.hosp-irb@koyu-kai.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20240001
Org. issuing International ID_1
Ethics Committee of Musashino Hospital, Koyukai Medical Corporation
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 22 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All patients will be asked to participate in this study during their first visit to the monognosis outpatient clinic at Musashino Hospital.
Specifically, at the end of the medical examination, the research director or the research collaborator at the research partner institution will explain the outline of this study in writing, and the participant will be asked to respond in a designated format (consent form) regarding their intention to participate in the study.
Based on the diagnosis name, dementia is classified into treatable and non-curable dementia, and a breakdown of each is obtained. In addition, the changes in scores of neuropsychological tests (MMSE, FAB, TMT-A/B, Rey's complex figure) are also described for each.
Treatable and non-treatable dementia are defined in the attached document.
Management information
Registered date
| 2024 | Year | 07 | Month | 21 | Day |
Last modified on
| 2024 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062354
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
