UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019992 |
|---|---|
| Receipt number | R000023004 |
| Scientific Title | Study of Outcome and a Polipoproteins in Dementia (STOP-Dementia): a single-center, prospective, observational study. |
| Date of disclosure of the study information | 2015/11/30 |
| Last modified on | 2020/06/03 10:00:06 |
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Basic information
Public title
Study of Outcome and a Polipoproteins in Dementia (STOP-Dementia): a single-center, prospective, observational study.
Acronym
STOP-Dementia
Scientific Title
Study of Outcome and a Polipoproteins in Dementia (STOP-Dementia): a single-center, prospective, observational study.
Scientific Title:Acronym
STOP-Dementia
Region
| Japan |
Condition
Condition
Alzheimer's disease
Mild cognitive impairment
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the relationship between apolipoproteins and cognitive functions in Alzheimer's disease and mild cognitive impairment
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between apolipoproteins and cognitive functions in Alzheimer's disease and mild cognitive impairment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in cognitive functions
Key secondary outcomes
DNA methylation, urine analysis, brain imaging, apolipoprotein, blood biochemical parameters, genotype (related to cognitive functions), inflammatory markers
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Alzheimer's disease
1) Outpatients in Kyoto Medical Center
2) Age >= 65
3) Diagnosed with Alzheimer's disease (NINDS-AIREN, DSM-5, ICD-10)
4) Diagnosed by medical specialist of Japan Society for Dementia Research or Japanese Society of Neurology
Mild cognitive impairment
1) Outpatients in Kyoto Medical Center
2) Age >= 65
3) Diagnosed with mild cognitive impairment (CDR)
4) Diagnosed by medical specialist of Japan Society for Dementia Research or Japanese Society of Neurology
Control
1) Outpatients in Kyoto Medical Center
2) Age >= 65
3) Normal cognitive function
4) Diagnosed by medical specialist of Japan Society for Dementia Research or Japanese Society of Neurology
Key exclusion criteria
Alzheimer's disease
1) Diffuse Lewy body disease
2) Frontotemporal dementia
3) The other neurodegenerative disease (progressive supranuclear palsy, corticobasal degeneration etc)
4) Immune-mediated disease (atypische encephalitis etc) in need of steroid therapy
5) Reversible dementia (hypothyroidism, chronic subdural hematoma, Wernicke's encephalopathy, chronic alcoholism etc)
6) Subjects who are judged as unsuitable for the study by the investigator or medical doctor for other reasons
Mild cognitive impairment
1) Diffuse Lewy body disease
2) Frontotemporal dementia
3) The other neurodegenerative disease (progressive supranuclear palsy, corticobasal degeneration etc)
4) Immune-mediated disease (atypische encephalitis etc) in need of steroid therapy
5) Reversible dementia (hypothyroidism, chronic subdural hematoma, Wernicke's encephalopathy, chronic alcoholism etc)
6) Subjects who are judged as unsuitable for the study by the investigator or medical doctor for other reasons
Control
1) Diagnosed with Alzheimer's disease or mild cognitive impairment
2) The other neurodegenerative disease (progressive supranuclear palsy, corticobasal degeneration etc)
3) Immune-mediated disease (atypische encephalitis etc) in need of steroid therapy
4) Subjects who are judged as unsuitable for the study by the investigator or medical doctor for other reasons
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Sakane |
Organization
Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name
Department of Preventive Medicine
Zip code
6128555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL
+81-75-641-9161
nsakane@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Sakane |
Organization
Clinical Research Institute, National Hospital Organization Kyoto Medical Center
Division name
Department of Preventive Medicine
Zip code
6128555
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
TEL
+81-75-641-9161
Homepage URL
nsakane@kyotolan.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Kyoto Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Council for Science, Technology and Innovation (CSTI), Cross-ministerial Strategic Innovation Promotion Program
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of National Hospital
Address
1-1 Fukakusa Mukaihata-cho, Fushimi-ku, Kyoto 612-8555, Japan
Tel
syomuhan@kyotolan.hosp.go.jp
syomuhan@kyotolan.hosp.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
| 2015 | Year | 11 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2030 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design
Prospective cohort study
Recruitment
Outpatients in Kyoto Medical Center in 2015 to 2020 year.
Measurements
cognitive functions, DNA methylation, urine analysis, brain imaging, apolipoprotein, blood biochemical parameters, genotype (related to cognitive functions), inflammatory markers
Management information
Registered date
| 2015 | Year | 11 | Month | 30 | Day |
Last modified on
| 2020 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023004
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
