UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	a study on SDI-DLB concerning to diagnose DLB and assess benefit for Donepezil : Study 2
Title of the study (Brief title)	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	Kenji Kosaka
Organization	Yokohama City University
Division name	emeritus professor
Address	3-9 Fukuura, kanazawa-ku, Yokohama-city
TEL	045-787-2667
Email	asako.yasuda@promedico.co.jp

Public contact
Name of contact person	Asako Yasuda
Organization	Promedico Co., Ltd.
Division name	Projects Promotion Department
Address	3-23-3 Takadanobaba, Shinjuku-ku, Tokyo
TEL	03-5332-3265
Homepage URL
Email	asako.yasuda@promedico.co.jp

Sponsor
Institute	Promedico Co., Ltd.
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021390