UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study about the impact of intensive instruction on the use of Aricept and the reasons for discontinuation in patients with Alzheimer's Disease
Title of the study (Brief title)	A study about the impact of intensive instruction on the use of Aricept and the reasons for discontinuation in patients with Alzheimer's Disease
Region	Japan

Condition
Condition	Alzheimer's Disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the influence of the instruction on the use of Aricept with educational brochure on the 48-wks medication persistence To assess the reasons for discontinuation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Medication persistence rate at 48 weeks Reasons for discontinuation
Key secondary outcomes	Factor analysis for medication persistence

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Behavior,custom
Interventions/Control_1	Intensive adherence instruction with educational brochure
Interventions/Control_2	Adherence instruction as per usual practice
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Diagnostic evidence of probable Alzheimer's type Dementia consistent with DSM-IV 2) Written informed consent will be obtained from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities 3) Patients having caregivers who submit written consent for cooperative involvements in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution 4) Outpatients in their own home
Key exclusion criteria	1) Patients treated with donepezil, galantamine, rivastigmine in 4 weeks immediately before enrollment 2) Known hypersensitivity to donepezil or piperadine derivatives 3) Involvement in any other investigational drug clinical trial during the preceding 12 weeks
Target sample size	150

Research contact person
Name of lead principal investigator	Tetsumasa Kamei
Organization	Shonan Fujisawa Tokushukai Hospital
Division name	Department of Neurology
Address	Tsujidoukamidai 1-5-1 Fujisawa-City, Kanagawa, Japan
TEL	0466-35-1177
Email	tetsumasakam@ctmc.jp

Public contact
Name of contact person	Tomoko Machida
Organization	Mirai Iryo Research Cneter Inc,
Division name	Clinical Research Administration Sec.
Address	Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan 102-0083
TEL	03-3263-4801
Homepage URL	http://www.mirai-iryo.com/
Email	machida@mirai-iryo.com

Sponsor
Institute	Shonan Fujisawa Tokushukai Hospital
Institute
Department

Funding Source
Organization	Eisai Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT01972204
Org. issuing International ID_1	ClinicalTrials.gov
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 12 Month 18 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 05 Day
Anticipated trial start date	2013 Year 10 Month 10 Day
Last follow-up date	2017 Year 08 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 12 Month 21 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 12 Month 18 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014751