UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012617
Receipt number R000014751
Scientific 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
Date of disclosure of the study information 2013/12/18
Last modified on 2018/06/07 12:43:59

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Basic information

Public 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

Acronym

A study about the impact of intensive instruction on the use of Aricept and the reasons for discontinuation in patients with Alzheimer's Disease

Scientific 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

Scientific Title:Acronym

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

1st name
Middle name
Last name Tetsumasa Kamei

Organization

Shonan Fujisawa Tokushukai Hospital

Division name

Department of Neurology

Zip code


Address

Tsujidoukamidai 1-5-1 Fujisawa-City, Kanagawa, Japan

TEL

0466-35-1177

Email

tetsumasakam@ctmc.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomoko Machida

Organization

Mirai Iryo Research Cneter Inc,

Division name

Clinical Research Administration Sec.

Zip code


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 or person

Institute

Shonan Fujisawa Tokushukai Hospital

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

2013 Year 09 Month 05 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014751


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name