UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010823 |
|---|---|
| Receipt number | R000012675 |
| Scientific Title | Risk factor and prevention of dementia and related disorders |
| Date of disclosure of the study information | 2013/06/01 |
| Last modified on | 2013/05/28 20:17:29 |
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Basic information
Public title
Risk factor and prevention of dementia and related disorders
Acronym
Risk factor and prevention of dementia and related disorders
Scientific Title
Risk factor and prevention of dementia and related disorders
Scientific Title:Acronym
Risk factor and prevention of dementia and related disorders
Region
| Japan |
Condition
Condition
Healthy control and subjects with Mild Cognitive Impairment (MCI)
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Explore the risk factor for dementia and perform intervention for prevention fo dementia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive change,structural and functional change of brain
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
exercise
Interventions/Control_2
control
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Residents in Tone town, Ibaraki prefecture whose age are over 65 years old.
Key exclusion criteria
not applicable
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Asada |
Organization
University of Tsukuba
Division name
Department of Psychiatry
Zip code
Address
1-1-1 Tennodai Tsukuba Ibaraki 305-8575 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tsukuba
Division name
Department of Psychiatry
Zip code
Address
1-1-1 Tennodai Tsukuba Ibaraki
TEL
Homepage URL
Sponsor or person
Institute
Department of Psychiatry, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare of Japan
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2001 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2007 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 28 | Day |
Last modified on
| 2013 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012675
