Skip to main content
OpenTrials
Completed

NCT Number: NCT01972204

Intensive Instruction on the Use of Aricept

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer's Type Dementia

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensive adherence instruction

Behavioral

Instruction with educational brochure

Control

Behavioral

Instruction as per usual practice

Primary outcomes

  1. Number of Participants With Medication Continuation

    Time frame: 48 weeks

    Number of Participants who Continue the Medication for 48 weeks

Secondary outcomes

  1. Reasons for Discontinuation

    Time frame: 48 weeks

    Reasons for discontinuation of the Medication

  2. 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

  3. Adverse Events

    Time frame: Week 2, 12, 24, 48

    Adverse Events for each arm

Sponsors and collaborators

Lead sponsor

Mirai Iryo Research Center, Inc.

Other

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Oct 30, 2013
Registry last updated
Jun 3, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.