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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028708
Receipt No. R000032863
Scientific Title A cross-sectional study of dementia in people with intellectual disability
Date of disclosure of the study information 2017/11/01
Last modified on 2019/08/19

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Basic information
Public title A cross-sectional study of dementia in people with intellectual disability
Acronym A cross-sectional study of dementia in people with intellectual disability
Scientific Title A cross-sectional study of dementia in people with intellectual disability
Scientific Title:Acronym A cross-sectional study of dementia in people with intellectual disability
Region
Japan

Condition
Condition intellectual disability
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 This study aims to investigate the prevalence of dementia among people with intellectual disability, and to evaluate the frequency of the symptoms associated with dementia.
Basic objectives2 Others
Basic objectives -Others Evaluating the reliability and the validity of the dementia screening tool for intellectual disability used abroad.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of dementia by age
Key secondary outcomes 1.Demography (age, sex, diagnosis)
2.Diagnosis of dementia
3.Type of dementia
4.Dementia symptoms
(Memory, Executive Function, Behavioral and Psychological Symptoms of Dementia, Activity of Daily Living, Adaptability)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Doctors perform a medical examination and diagnose the presence or absence of dementia.
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 using the target welfare facilities in Okayama prefecture managed by collaborative research institutes in November 1, 2017.
2.Patients with intellectual disability
3.Legal representatives of patients fully understand this study and give written informed consent for the participation in this study. (If the patient has ability to understand this study and to give written informed consent to participate in this study, both the patient and his/her legal representative give written informed consent. )
Key exclusion criteria Patients who are not appropriate for participation in this study because of their health condition as judged by the doctor.
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Seishi
Middle name
Last name Terada
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Neuropsychiatry
Zip code 700-8558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL 086-235-7246
Email terada@okayama-u.ac.jp

Public contact
Name of contact person
1st name Seishi
Middle name
Last name Terada
Organization Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Division name Department of Neuropsychiatry
Zip code 700-8558
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
TEL 086-235-7246
Homepage URL
Email terada@okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization Okayama University
Japan Society for the Promotion of Science/MEXT(Japan)
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Asahigawasou
Asahigawasou Research Institute
Name of secondary funder(s) None

IRB Contact (For public release)
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address 2-5-1, Shikata-cho, Kita-ku, Okayama, 700-8558, Japan.
Tel 086-235-6503
Email mae6605@adm.okayama-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 旭川荘(岡山県)

Other administrative information
Date of disclosure of the study information
2017 Year 11 Month 01 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 493
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 Completed
Date of protocol fixation
2017 Year 08 Month 22 Day
Date of IRB
2017 Year 08 Month 22 Day
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
2019 Year 03 Month 30 Day
Date of closure to data entry
2019 Year 03 Month 30 Day
Date trial data considered complete
2019 Year 03 Month 30 Day
Date analysis concluded
2019 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 17 Day
Last modified on
2019 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032863

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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