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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033155
Receipt No. 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

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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
Email 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
Email heii@juntendo.ac.jp

Sponsor
Institute Juntendo School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037794

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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