Intensive Instruction on the Use of Aricept

February 17, 2019 updated by: Tetsumasa Kamei, Mirai Iryo Research Center, Inc.

A Study About the Impact of Intensive Instruction on the Use of Aricept and the Reasons for Discontinuation in Patients With Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Kanagawa
      • Fujisawa, Kanagawa, Japan
        • Shonan Fujisawa Tokushukai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intensive adherence instruction
Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure
Behavioral: Intensive adherence instruction
Instruction with educational brochure
Sham Comparator: Control
The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.
Behavioral: Control
Instruction as per usual practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Medication Continuation
Time Frame: 48 weeks
Number of Participants who Continue the Medication for 48 weeks
48 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reasons for Discontinuation
Time Frame: 48 weeks
Reasons for discontinuation of the Medication
48 weeks
Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics
Time Frame: 48 weeks
Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics
48 weeks
Adverse Events
Time Frame: Week 2, 12, 24, 48
Adverse Events for each arm
Week 2, 12, 24, 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirai Iryo Research Center, Inc.

Investigators

  • Principal Investigator: Tetsumasa Kamei, Shonan Fujisawa Tokushukai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

October 24, 2013

First Submitted That Met QC Criteria

October 24, 2013

First Posted (Estimate)

October 30, 2013

Study Record Updates

Last Update Posted (Actual)

June 3, 2019

Last Update Submitted That Met QC Criteria

February 17, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ART-2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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