UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000055015 |
|---|---|
| Receipt number | R000062851 |
| Scientific Title | Development and validation of Japanese version of Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) |
| Date of disclosure of the study information | 2024/07/18 |
| Last modified on | 2024/07/18 19:38:22 |
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Basic information
Public title
Development and validation of Japanese version of Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL)
Acronym
Development of Japanese version of ADCS-MCI-ADL
Scientific Title
Development and validation of Japanese version of Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL)
Scientific Title:Acronym
Development and validation of Japanese version of ADCS-MCI-ADL
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to develop and validate the Japanese version of ADCS-MCI-ADL (ADCS-MCI-ADL-J).
Basic objectives2
Others
Basic objectives -Others
To develop and validate the ADCS-MCI-ADL-J
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reliability, validity, and interpretability of ADCS-MCI-ADL-J
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Inclusion criteria>
- Diagnosis of MCI due to AD or ADD according to the National Institute on Aging-Alzheimer's Association 2011 criteria
- Clinical Dementia Rating (CDR) global score < 2
- Over 40 years old
- Existence of caregivers who are familiar with participant's daily livings
- Written informed consent was obtained from patients and/or caregivers.
<Inclusion criteria for healthy control>
- Over 40 years old
- Absence of subjective cognitive decline
- Absence of obvious cognitive impairment
- Absence of obvious disability in ADL
- Written informed consent was obtained from participants
Key exclusion criteria
<Exclusion criteria>
- Drug induced, or vascular dementia
- Existence of severe medical disease
- Comorbidity of other psychiatric disease such as schizophrenia, mood disorders, or drug abuse
- Judgment made by the research director/co-researcher that study participation would negatively influence the patient's condition
<Exclusion criteria for healthy control>
- Existence of psychiatric or neurological disease that impair the cognitive function
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Ikeda |
Organization
Osaka University
Division name
Department of Psychiatry, Course of Integrated Medicine, Graduate School of Medicine
Zip code
565-0871
Address
2-2 D3, Yamadaoka, Suita-city, Osaka
TEL
06-6879-3051
mikeda@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Daiki |
| Middle name | |
| Last name | Ishimaru |
Organization
Osaka University Hospital
Division name
Department of Medical Technology
Zip code
565-0871
Address
2-15, Yamadaoka, Suita-city, Osaka
TEL
06-6879-3051
Homepage URL
d.ishimaru@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board Osaka University Hospital
Address
2-2, Yamadaoka, Suita-city, Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
| 2024 | Year | 07 | Month | 18 | 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
| 2023 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 11 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Participants are inpatients or outpatients at study institutions between 13 October 2023 and 31 March 2026, who meet the inclusion criteria and do not meet the exclusion criteria.
Management information
Registered date
| 2024 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062851
