UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035971 |
|---|---|
| Receipt number | R000040953 |
| Scientific Title | prospective study of mild cognitive impairment and dementia in Kurashiki. |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2023/02/24 19:49:04 |
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Basic information
Public title
prospective study of mild cognitive impairment and dementia in Kurashiki.
Acronym
prospective study of mild cognitive impairment and dementia in Kurashiki.
Scientific Title
prospective study of mild cognitive impairment and dementia in Kurashiki.
Scientific Title:Acronym
prospective study of mild cognitive impairment and dementia in Kurashiki.
Region
| Japan |
Condition
Condition
dementia,Mild cognitive impairment
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishiment of clinical biomarker for dementia.
Basic objectives2
Others
Basic objectives -Others
Clinical information to be collected (patient basic information, diagnosis, comprehensive function, neuropsychological data, physical function, brain imaging, blood, cerebrospinal fluid), efficiently register, and data accumulation to create a system that can utilize data.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
neuropsychological data(MMSE, HDS-R, FAB)
Key secondary outcomes
EEG, MRI, SPECT
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 over the age of 20 who have been diagnosed with dementia or MCI.
Key exclusion criteria
no
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masahito |
| Middle name | |
| Last name | Mihara |
Organization
Kawasaki Medical School
Division name
Neurology
Zip code
7010192
Address
577 Matsushima, Kurashiki Okayama 701-0192, Japan
TEL
0864621111
mihara@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Yumiko |
| Middle name | |
| Last name | Kutoku |
Organization
Kawasaki Medical School
Division name
neurology
Zip code
7010192
Address
577 Matsushima, Kurashiki Okayama 701-0192, Japan
TEL
0864621111
Homepage URL
kutoku@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
Funding Source
Organization
Kawasaki Medical School
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki Medical School
Address
577 Matsushima, Kurashiki Okayama 701-0192, Japan
Tel
0864621111
kutoku@med.kawasaki-m.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
| 2019 | Year | 05 | 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
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
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is prospective cohot investigating effective biomarker for dementia progression,using annual clinical data(neuropsychological examination, EEG, MRI and SPECT etc.)
Management information
Registered date
| 2019 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040953
