UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030436 |
|---|---|
| Receipt number | R000034643 |
| Scientific Title | Examination of predicting factor of cognitive decline |
| Date of disclosure of the study information | 2018/01/01 |
| Last modified on | 2019/12/19 16:47:03 |
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Basic information
Public title
Examination of predicting factor of cognitive decline
Acronym
Study of predicting factor of cognitive decline
Scientific Title
Examination of predicting factor of cognitive decline
Scientific Title:Acronym
Study of predicting factor of cognitive decline
Region
| Japan |
Condition
Condition
Diabetes Mellitus, traumatic brain injury, depression, mild cognitive impairment
Classification by specialty
| Endocrinology and Metabolism | Neurology | Geriatrics |
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the predictive factor of the cognitive decline in each diseases
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
examination at the initial evaluation:
signal of [18F]flrobetapir
Key secondary outcomes
examination at the initial evaluation, 1 year evaluation, 2 year evaluation:
cognitive function
blood test
urine test
clinical symptoms
diagnosis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Initial evaluation:
[18F]flrobetapir PET (370MBq), MRI, Neuropsychological examination, blood test, urine test
1st year evaluation:
Neuropsychological examination, blood test, urine test
2nd year evaluation:
Neuropsychological examination, blood test, urine test
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects (20 y.o. <= age <90 y.o.) who have the ability to provide informed consent and adhere to the protocol.
Diabetes mellitus:
- Subjects who meet the critera of diabetes mellitus on the Japan Diabetes Society without past history of traumatic brain injury and major depressive disorder
Traumatic brain in jury:
Subjects with past history of traumatic brain injury, without past history of diabetes mellitus and major depressive disorder
Major depressive disorder:
- Subject who meet the diagnostic criteria of depressive episode on International classification of Diseases 10th revision
Mild cognitive impairment:
- Subject who had subjective and objective cognitive impairment without past history of diabetes mellitus, traumatic brain injury
Key exclusion criteria
- With past or current history of serious medical illness
- Subject who cannot undergo an MRI
- With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- Subjects who has possibility of pregnancy or is breast-feeding
- Subjects who has been exposed to radiation by job-related exposure or therapy in one year exceeding 15mSv
- Subjects who received contrast or radioactive agent within two days of the examination.
- Subjects who scheduled receiving contrast or radioactive agent the day after the examination.
- Subjects who are judged as not suitable for participation in this study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Yoshiro |
| Middle name | |
| Last name | Okubo |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
okubo-y@nms.ac.jp
Public contact
Name of contact person
| 1st name | Amane |
| Middle name | |
| Last name | Tateno |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
113-8602
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
Homepage URL
amtateno@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
MEXT
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nippon Medical School Hospital Institutional Review Board
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
Tel
+81-3-3822-2131
clinicaltrial@nms.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | 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
0
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
Terminated
Date of protocol fixation
| 2017 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2021 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 17 | Day |
Last modified on
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034643
