UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033149 |
|---|---|
| Receipt number | R000037520 |
| Scientific Title | Epidemiological Study of Subjective Cognitive Decline (SCD) |
| Date of disclosure of the study information | 2018/07/01 |
| Last modified on | 2022/08/29 17:00:21 |
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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
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
takaoka-y@a2healthcare.com
Sponsor or person
Institute
Juntendo University Hospital
Eisai Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037520
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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