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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033149
Receipt No. R000037520
Scientific Title Epidemiological Study of Subjective Cognitive Decline (SCD)
Date of disclosure of the study information 2018/07/01
Last modified on 2020/06/29

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Basic information
Public title Epidemiological Study of Subjective Cognitive Decline (SCD)
Acronym MISSION SCD
Scientific Title Epidemiological Study of Subjective Cognitive Decline (SCD)
Scientific Title:Acronym MISSION SCD
Region
Japan

Condition
Condition Subjective Cognitive Decline: SCD
Classification by specialty
Neurology Psychosomatic Internal Medicine Geriatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate what SCD with background factors specific to Japanese is likely to transfer to MCI, and how it affects the prognosis from the view point of mild behavior impairment (MBI), dysosmia, lifestyle, etc.
Basic objectives2 Others
Basic objectives -Others Prospective observational study
Trial characteristics_1 Others
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Targeting SCD, the change from the baseline of the Clinical Dementia Rating (CDR) and The Rivermead Behavioural Memory Test (RBMT) will be monitored as indicators for 24 months, and the rate of subjects when transferring to MCI will be examined.
Key secondary outcomes The clinical change (SCD-Q, MBI-C, GDS-15-J, UPSIT) when SCD is transferred to MCI within 24 months will be evaluated, and the background factors that led the transfer to MCI will be examined.

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
50 years-old <=
Age-upper limit
85 years-old >=
Gender Male and Female
Key inclusion criteria (i)Persons between 50 to 85 when informed consent is obtained.
(ii)A subject who recognizes that cognitive functioning is lower than before, but objective cognitive decline cannot be confirmed by neuropsychological testing at the baseline.
(iii)A person who fully understands the study protocol and who provides freely given written informed consent.
(iv) A person who has a specific study partner.
Key exclusion criteria (i)A person who is in the state that may affect impaired cognitive function.
(ii)A person who has experienced epileptic seizures in the past five years before screening or who is observed to have a disability in the past five years before screening, and it very likely due to epileptic seizures.
(iii)A person who had transient ischemic attacks or strokes in the past 12 months before screening.
(iv)A person whose revised version of the Hachinski Ischemic Score is 5 or more during screening.
(v)A person with mental disorders or mental symptoms that is considered by the study investigator or the study subinvestigator to have the possibility of interfering with the implementation of the study.
(vi)A person who uses a cardiac pacemaker, defibrillator, or ferromagnetic metallic implant, which is considered to be a contraindication to MRI testing.
(vii)A person who shows a clinically relevant lesion that supports the diagnosis of dementia in MRI testing during screening. Other than the above, a person with a clinically relevant pathological finding other than dementia.
(viii)A person whose laboratory results during screening fall into either of the following:
A person whose TSH value exceeds the upper limit of the baseline.
A person whose vitamin B12 value in serum is abnormally low.
(ix)Other than the above, a person who is judged to be inappropriate as a subject by the principle investigator.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Heii
Middle name
Last name Arai
Organization Juntendo University Hospital
Division name Mental Clinic
Zip code 113-8431
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3813-3111
Email heii@juntendo.ac.jp

Public contact
Name of contact person
1st name Yukina
Middle name
Last name Takaoka
Organization A2 Healthcare Corporation
Division name Clinical Research Department
Zip code 112-0002
Address 17th floor, Sumitomo Fudosan Korakuen Bldg. 1-4-1, Koishikawa, Bunkyo-Ku, Tokyo 112-0002 JAPAN
TEL 03-3830-1075
Homepage URL
Email takaoka-y@a2healthcare.com

Sponsor
Institute Juntendo University Hospital
Eisai Co., Ltd.
Institute
Department

Funding Source
Organization Eisai Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Juntendo University Hospital
Address 3-1-3, Hongo, Bunkyo-ku, Tokyo, Japan
Tel 03-5802-1584
Email kenkyu5858@juntendo.ac.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 順天堂大学医学部附属順天堂医院(東京都)等

Other administrative information
Date of disclosure of the study information
2018 Year 07 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 No longer recruiting
Date of protocol fixation
2017 Year 12 Month 11 Day
Date of IRB
2018 Year 01 Month 05 Day
Anticipated trial start date
2018 Year 07 Month 27 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To investigate what SCD with background factors specific to Japanese is likely to transfer to MCI, and how it affects the prognosis from the view point of mild behavior impairment (MBI), dysosmia, lifestyle, etc.

Management information
Registered date
2018 Year 06 Month 26 Day
Last modified on
2020 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037520

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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