Intensive Instruction on the Use of Aricept

Not Applicable

Completed

• Conditions: Alzheimer's Type Dementia
• Interventions: Behavioral: Control; Behavioral: Intensive adherence instruction

• Registration Number: NCT01972204
• Lead Sponsor: Mirai Iryo Research Center, Inc.

Brief Summary

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

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 Timeline

• Study Start: 2013-09
• Study First Submitted: 2013-10-24
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-30
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2018-09-20
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-17
• Last Update Submitted: 2019-02-17
• Results First Posted: 2019-06-03
• Last Update Posted: 2019-06-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.
Intensive adherence instruction	Intensive adherence instruction	Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure

Primary Outcome Measures

Name	Time	Method
Number of Participants With Medication Continuation	48 weeks	Number of Participants who Continue the Medication for 48 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Shonan Fujisawa Tokushukai Hospital; 🇯🇵 Fujisawa, Kanagawa, Japan