Intensive Instruction on the Use of Aricept

NCT ID: NCT01972204

Last Updated: 2019-06-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2017-08-31

Brief Summary

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The purpose of this study is to examine the influence of the instruction on the use of Aricept with educational brochure on the 48-week medication persistence and to assess the reasons for discontinuation.

Detailed Description

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To examine the influence of the instruction on the use of Aricept with educational brochure comparing to the ordinary instruction on the 48-week medication persistence and to assess the reasons for discontinuation.

Conditions

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Alzheimer's Type Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intensive adherence instruction

Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure

Group Type EXPERIMENTAL

Intensive adherence instruction

Intervention Type BEHAVIORAL

Instruction with educational brochure

Control

The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.

Group Type SHAM_COMPARATOR

Control

Intervention Type BEHAVIORAL

Instruction as per usual practice

Interventions

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Intensive adherence instruction

Instruction with educational brochure

Intervention Type BEHAVIORAL

Control

Instruction as per usual practice

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnostic evidence of probable Alzheimer's type Dementia consistent with DSM-IV.
* Written informed consent will be obtained from subject (if possible) or from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities.
* Patients having caregivers who submit written consent for cooperative involvement in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution.
* Outpatients in their own home.

Exclusion Criteria

* Patients treated with donepezil, galantamine, rivastigmine in 4 weeks immediately before enrollment.
* Known hypersensitivity to donepezil or piperidine derivatives.
* Involvement in any other investigational drug clinical trail during the preceding 12 weeks.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mirai Iryo Research Center, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Tetsumasa Kamei

Hospital Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tetsumasa Kamei

Role: PRINCIPAL_INVESTIGATOR

Shonan Fujisawa Tokushukai Hospital

Locations

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Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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ART-2013-01

Identifier Type: -

Identifier Source: org_study_id

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