Intensive Instruction on the Use of Aricept

Alzheimer's Type Dementia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972204
• Other study ID #: ART-2013-01
• Status: Completed
• Phase: N/A
• Start date: September 2013
• Est. completion date: August 2017

Study information

• Verified date: February 2019
• Source: Mirai Iryo Research Center, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Type Dementia

Intervention

Behavioral:
• Intensive adherence instruction
Instruction with educational brochure
• Control
Instruction as per usual practice

Locations

Country	Name	City	State
Japan	Shonan Fujisawa Tokushukai Hospital	Fujisawa	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Mirai Iryo Research Center, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Medication Continuation	Number of Participants who Continue the Medication for 48 weeks	48 weeks
Secondary	Reasons for Discontinuation	Reasons for discontinuation of the Medication	48 weeks
Secondary	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	48 weeks
Secondary	Adverse Events	Adverse Events for each arm	Week 2, 12, 24, 48