UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022795 |
|---|---|
| Receipt number | R000026273 |
| Scientific Title | A study on online registry of healthy volunteers and subjects with preclinical Alzheimer's disease for the prevention of dementia |
| Date of disclosure of the study information | 2016/06/20 |
| Last modified on | 2021/06/24 09:56:20 |
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Basic information
Public title
A study on online registry of healthy volunteers and subjects with preclinical Alzheimer's disease for the prevention of dementia
Acronym
Online regitry of healthy volunteers for the prevention of dementia
Scientific Title
A study on online registry of healthy volunteers and subjects with preclinical Alzheimer's disease for the prevention of dementia
Scientific Title:Acronym
Online regitry of healthy volunteers for the prevention of dementia
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
With the rapid aging of the global population, cognitive decline and dementia pose large-scale healthcare and socioeconomic burdens. Strategies to address these burdens are urgently needed, particularly for dementia due to Alzheimer's disease (AD). Such strategies include the development of disease modifying therapies (DMT) for AD but must also incorporate a preventive approach to reducing risk factors. Over the past 10 years, AD DMT clinical trials have been largely unsuccessful, partly due to difficulty in recruiting early stage patients for enrollment. In addition, successful AD prevention trials will require a better understanding of the complex relationships between cognitive and functional abilities, risk factors, and life style choices. Establishing a large-scale registry for healthy and at risk individuals will play a key role in efficiently addressing these issues.
Basic objectives2
Others
Basic objectives -Others
To investigate relationship between lifestyle and dementia
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Longitudinal measures of memory performance index
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
People to understand the Japanese over the age of 40
Key exclusion criteria
People under the age of 40
Target sample size
30000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsuda |
Organization
National Center of Neurology and Psychiatry
Division name
Integrative Brain Imaging Center
Zip code
187-8551
Address
4-1-1, Ogawahigashi, Kodaira
TEL
0423412712
matsudah@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Matsuda |
Organization
National Center of Neurology and Psychiatry
Division name
Integrative Brain Imaging Center
Zip code
187-8551
Address
4-1-1, Ogawahigashi, Kodaira
TEL
0423412712
Homepage URL
matsudah@ncnp.go.jp
Sponsor or person
Institute
National Center of Neurology and Psychiatry
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for 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
National Center of Neurology and Psychiatry
Address
4-1-1, Ogawahigashi, Kodaira
Tel
0423412711
rinri-jimu@ncnp.go.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
| 2016 | Year | 06 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Ogawa M, et al. Alzheimers Dement (NY) 5:347-353,2019
Number of participants that the trial has enrolled
5700
Results
This study assessed the longitudinal changes in the collated data for predicting the risk of dementia and included 473 individuals registered in the IROOP who completed the initial questionnaire and brief assessment of cognitive function (MCI Screen) at baseline and the regular questionnaire and the MCI Screen at least once after baseline.
Mood, sleep, quality of life, and medical histories including cognition were found to influence longitudinal changes in cognitive function.
Results date posted
| 2019 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 08 | Month | 02 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 03 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 17 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 17 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 17 | Day |
Other
Other related information
We have developed a nation-wide, online registry system for healthy or at risk individuals over 40 years old in Japan. Every 6 months, registered participants answer an online questionnaire including demographics, mood, quality of life, sleep,and so on, and take a brief neuropsychological assessment (MCI Screen) over the phone. The MCIS includes the well-validated 10-word recall protocol used in the CERAD and ADAS-Cog batteries.
Management information
Registered date
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2021 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026273
