Back to resultsIntensive Instruction on the Use of Aricept
Primary Purpose
Alzheimer's Type Dementia
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Intensive adherence instruction
Control
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Type Dementia
Eligibility Criteria
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.
Sites / Locations
- Shonan Fujisawa Tokushukai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Intensive adherence instruction
Control
Arm Description
Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure
The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.
Outcomes
Primary Outcome Measures
Number of Participants With Medication Continuation
Number of Participants who Continue the Medication for 48 weeks
Secondary Outcome Measures
Reasons for Discontinuation
Reasons for discontinuation of the Medication
Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics
Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics
Adverse Events
Adverse Events for each arm
Full Information
NCT ID
NCT01972204
First Posted
October 24, 2013
Last Updated
February 17, 2019
Sponsor
Mirai Iryo Research Center, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01972204
Brief Title
Intensive Instruction on the Use of Aricept
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mirai Iryo Research Center, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Type Dementia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intensive adherence instruction
Arm Type
Experimental
Arm Description
Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.
Intervention Type
Behavioral
Intervention Name(s)
Intensive adherence instruction
Intervention Description
Instruction with educational brochure
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
Instruction as per usual practice
Primary Outcome Measure Information:
Title
Number of Participants With Medication Continuation
Description
Number of Participants who Continue the Medication for 48 weeks
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Reasons for Discontinuation
Description
Reasons for discontinuation of the Medication
Time Frame
48 weeks
Title
Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics
Description
Number of Participants who descontinue the Clinical Trial Medication due to Change to Alicept (not for clinical trial) or Generics
Time Frame
48 weeks
Title
Adverse Events
Description
Adverse Events for each arm
Time Frame
Week 2, 12, 24, 48
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tetsumasa Kamei
Organizational Affiliation
Shonan Fujisawa Tokushukai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shonan Fujisawa Tokushukai Hospital
City
Fujisawa
State/Province
Kanagawa
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Intensive Instruction on the Use of Aricept
We'll reach out to this number within 24 hrs