UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018813 |
|---|---|
| Receipt number | R000021390 |
| Scientific Title | a study on SDI-DLB concerning to diagnose DLB and assess benefit for Donepezil : Study 2 |
| Date of disclosure of the study information | 2015/08/28 |
| Last modified on | 2017/11/27 15:40:16 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
a study on SDI-DLB concerning to diagnose DLB and assess benefit for Donepezil : Study 2
Acronym
SDI-DLB: diagnose DLB and assess benefit for Donepezil(Study 2)
Scientific Title
a study on SDI-DLB concerning to diagnose DLB and assess benefit for Donepezil : Study 2
Scientific Title:Acronym
SDI-DLB: diagnose DLB and assess benefit for Donepezil(Study 2)
Region
| Japan |
Condition
Condition
DLB
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess benefit for Donepezil with SDI-DLB
Basic objectives2
Others
Basic objectives -Others
usability of SDI-DLB
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The changes on SDI-DLB 4, and 12 weeks after starting medication.
Key secondary outcomes
The changes in scales of MMSE, EQ-5D and PSMS at 12 weeks after starting medication.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Medication of Donepezil (3-10mg per day) for 12 weeks.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)met criteria of probable DLB in CDLB 3rd
2)gave informed consent
3)60 years old or more of age
4)outpatients or home visited patients
5)have carer spend time with 72 hours or more every week
6)not dozed Donepezil within 12 weeks before informed consent
Key exclusion criteria
1)dozed antidementia drugs except Donepezil within 12 weeks before informed consent
2)bed ridden
3)with severe impairment of visual acuity, auditory sensor and/or communication
4)with neurological degenerative disease except for DLBV criteria, schizophrenia, bipolar disorder and major depression
5)with delirium due to abuse of alcohol, drugs, metabolic toxicity and inflammation
6)inadequate decided by principal investigator
7)with hypersensitivity to components of Donepezil or piperidine derivative
8)dozed investigational drug within 12 weeks before informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Kosaka |
Organization
Yokohama City University
Division name
emeritus professor
Zip code
Address
3-9 Fukuura, kanazawa-ku, Yokohama-city
TEL
045-787-2667
asako.yasuda@promedico.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asako Yasuda |
Organization
Promedico Co., Ltd.
Division name
Projects Promotion Department
Zip code
Address
3-23-3 Takadanobaba, Shinjuku-ku, Tokyo
TEL
03-5332-3265
Homepage URL
asako.yasuda@promedico.co.jp
Sponsor or person
Institute
Promedico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Eisai Co., Ltd.
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
Address
Tel
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
| 2015 | Year | 08 | Month | 28 | 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
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 26 | Day |
Last modified on
| 2017 | Year | 11 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021390
