UMIN-CTR Clinical Trial

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	Completed
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	2022 Year 08 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037520