UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of donepezil in Alzheimer's disease combined with cerebrovascular disease
Title of the study (Brief title)	Donepezil in Alzheimer's disease combined with cerebrovascular disease
Region	Japan

Condition
Condition	Alzheimer's disease
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effects of donepezile in patients with a diagnosis of Alzheimer's disease combined with cerebrovascular disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	MMSE-J
Key secondary outcomes	CDR

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Alzheimer disease
Interventions/Control_2	Alzheimer disease ombined with cerebrovascular disease
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Alzheimer disease or Alzheimer disease ombined with cerebrovascular disease
Key exclusion criteria	other dementia
Target sample size	460

Research contact person
Name of lead principal investigator	Norihiro Suzuki
Organization	Keio University,
Division name	Department of Neurology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	0353633788
Email	nrsuzuki@a2.keio.jp

Public contact
Name of contact person	Daisuke Ito
Organization	Keio University,
Division name	Department of Neurology
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	0353633788
Homepage URL
Email	d-ito@jk9.so-net.ne.jp

Sponsor
Institute	Department of Neurology, Keio University,
Institute
Department

Funding Source
Organization	Department of Neurology, Keio University,
Organization
Division
Category of Funding Organization	Other
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	2013 Year 04 Month 07 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 04 Month 06 Day
Anticipated trial start date	2013 Year 05 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	The entry of the study cooperator was difficult within research period.
Other related information

Management information
Registered date	2013 Year 04 Month 03 Day
Last modified on	2016 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012178