UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034676 |
|---|---|
| Receipt number | R000039534 |
| Scientific Title | Intervention and Biomarker for Mild Cognitive Impairment |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2019/05/07 15:15:15 |
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Basic information
Public title
Intervention and Biomarker for Mild Cognitive Impairment
Acronym
IBMCI
Scientific Title
Intervention and Biomarker for Mild Cognitive Impairment
Scientific Title:Acronym
IBMCI
Region
| Japan |
Condition
Condition
Mild Cognitive Impairment
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In this study, an effective intervention approach for the progression of elderly with high dementia risk and exploratory study of useful biomarkers correlated with cognitive function are conducted.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
logical memory II after 6 months intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Synapsology
6 months ( 2 times/week, 30 min/time)
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
| 65 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
MMSE (Mni-mental state examination) >= 22
CDR (Clinical Dementia Rating) = 0.5
Logical memory II <= -1SD adjusted by education year
GDS (Geriatric Depression Scale) <= 6
Participant's own consent
Key exclusion criteria
History of dementia
History of neurological/psychiatric disease
Severe visual or auditory impairment
Serious complications
MRI can not shoot
People can not stand quietly by resting for about 1 hour.
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Shuhei |
| Middle name | |
| Last name | Yamaguchi |
Organization
Shimane University
Division name
Department of Neurology, Faculty of Medicine
Zip code
693-8501
Address
89-1, Enyacho, Izumo, Shimane
TEL
0853-20-2198
yamagu3n@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Onoda |
| Middle name | |
| Last name | Keiichi |
Organization
Shimane University
Division name
Department of Neurology, Faculty of Medicine
Zip code
693-8501
Address
89-1, Enyacho, Izumo, Shimane
TEL
0853-20-2198
Homepage URL
onodak1@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
Funding Source
Organization
SHIMAZU
Medical Care Service
ERISA
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
The Shimane University Institutional Committee on Ethics
Address
Enyacho, 89-1, Izumo, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-u.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 | 12 | 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 | 11 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 29 | Day |
Last modified on
| 2019 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039534
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
