UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050417 |
|---|---|
| Receipt number | R000057410 |
| Scientific Title | Prospective cohort study on development of neurological disorders -Yahaba Active Aging and Healthy Brain study- |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/02/26 17:00:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prospective cohort study on development of neurological disorders -Yahaba Active Aging and Healthy Brain study-
Acronym
YAHABA study
Scientific Title
Prospective cohort study on development of neurological disorders -Yahaba Active Aging and Healthy Brain study-
Scientific Title:Acronym
YAHABA study
Region
| Japan |
Condition
Condition
Neurological disorders
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate prevalence rates, risk factors and development of the neurological disorders in community-dwelling older adults in Yahaba
Basic objectives2
Others
Basic objectives -Others
To investigate prevalence rates, risk factors and development of the neurological disorders in community-dwelling older adults in Yahaba
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Development of the neurological disorders including Alzheimer's disease, Parkinson's disease, cerebrovascular disease, and so on
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
| 65 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) 65 years or more at registration
(2) Community-dwelling person in Yahaba town
(3) Given informed consent
Key exclusion criteria
(1) People without informed consent
Target sample size
1500
Research contact person
Name of lead principal investigator
| 1st name | Tetsuya |
| Middle name | |
| Last name | Maeda |
Organization
Iwate Medical University
Division name
Division of Neurology and Gerontology, Department of Internal Medicine, School of Medicine
Zip code
028-3694
Address
1-1-1, Idaidori, Yahaba, Shiwa, Iwate
TEL
+81-19-651-5111
maeda@iwate-med.ac.jp
Public contact
Name of contact person
| 1st name | Tetsuya |
| Middle name | |
| Last name | Maeda |
Organization
Iwate Medical University
Division name
Division of Neurology and Gerontology, Department of Internal Medicine, School of Medicine
Zip code
028-3694
Address
1-1-1 Idaidori, Yahaba, Shiwa, Iwate
TEL
+81-19-651-5111
Homepage URL
maeda@iwate-med.ac.jp
Sponsor or person
Institute
Iwate Medical University
Institute
Department
Personal name
Tetsuya Maeda
Funding Source
Organization
Japan Agency of Medical Research and Development
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
Institutional Review Board of Iwate Medical University
Address
1-1-1 Idaidori, Yahaba, Shiwa, Iwate
Tel
+81-19-651-5111
kenkyu-rinri@j.iwate-med.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
| 2023 | Year | 06 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study investigating the prevalence rates, risk factors and development on the neurological disorders in community-dwelling older adults. Yahaba is a small town locating in Iwate prefecture of the north-eastern Japan, having around 8,000 older adults. This study registered around 1000 older people living in Yahaba town and screened their health-related various measures and corrected medical information. All participants are continuously investigated in age-related neurological diseases, which include Alzheimer's disease, Parkinson's disease, cerebrovascular disease, and so on. This study can supply the real-world epidemiological evidences and can contribute the development of intervention to the neurological diseases.
Management information
Registered date
| 2023 | Year | 02 | Month | 23 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057410
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
