UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033155 |
|---|---|
| Receipt number | R000037794 |
| Scientific Title | A follow-up study on subjective cognitive decline (SCD) |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2018/06/26 19:01:51 |
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Basic information
Public title
A follow-up study on subjective cognitive decline (SCD)
Acronym
A follow-up study on subjective cognitive decline (SCD)
Scientific Title
A follow-up study on subjective cognitive decline (SCD)
Scientific Title:Acronym
A follow-up study on subjective cognitive decline (SCD)
Region
| Japan |
Condition
Condition
Subjective cognitive decline: SCD
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
How do subjects with subjective cognitive decline (SCD) progress?
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Conversion rate to mild cognitive impairment during the follow-up term (2years)
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.age: between 50 and 85 years old
2.subjective cognitive decline
3.presence of study partner
Key exclusion criteria
1.past history of epilepsy
2.past history of apoplexy
3.Hachinski:<5 points
4.Presence of psychosis
5.MRI findings that suggest diagnosis of dementia
6.Abnormal finding in TSH in blood
7.past history of cancer
8.alcohol abuse or dependence
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Heii Arai |
Organization
Juntendo Graduate School of Medicine
Division name
Department of Psychiatry Behavioral Science
Zip code
Address
2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL
03-3813-3111
heii@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Heii Arai |
Organization
Juntendo Graduate School of Medicine
Division name
Department of Psychiatry Behavioral Science
Zip code
Address
2-1-1 Hongo,Bunkyo-ku,Tokyo
TEL
03-3813-3111
Homepage URL
heii@juntendo.ac.jp
Sponsor or person
Institute
Juntendo School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Eisai Co.,LTD.
Organization
Division
Category of Funding Organization
Profit 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
| 2018 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 07 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 07 | Month | 10 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
cohort study
2018/08-2019/02 study participation
applicant of out-patients
neuropsychological examination
Management information
Registered date
| 2018 | Year | 06 | Month | 26 | Day |
Last modified on
| 2018 | Year | 06 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037794
