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Intensive Instruction on the Use of Aricept

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01972204
Recruitment Status : Completed
First Posted : October 30, 2013
Results First Posted : June 3, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Tetsumasa Kamei, Mirai Iryo Research Center, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Type Dementia Behavioral: Intensive adherence instruction Behavioral: Control Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2013
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Medication Continuation [ Time Frame: 48 weeks ]
    Number of Participants who Continue the Medication for 48 weeks


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01972204


Locations
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Japan
Shonan Fujisawa Tokushukai Hospital
Fujisawa, Kanagawa, Japan
Sponsors and Collaborators
Mirai Iryo Research Center, Inc.
Investigators
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Principal Investigator: Tetsumasa Kamei Shonan Fujisawa Tokushukai Hospital
  Study Documents (Full-Text)

Documents provided by Tetsumasa Kamei, Mirai Iryo Research Center, Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] September 5, 2013

More Information
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Responsible Party: Tetsumasa Kamei, Hospital Director, Mirai Iryo Research Center, Inc.
ClinicalTrials.gov Identifier: NCT01972204    
Other Study ID Numbers: ART-2013-01
First Posted: October 30, 2013    Key Record Dates
Results First Posted: June 3, 2019
Last Update Posted: June 3, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Neurocognitive Disorders
Mental Disorders
Tauopathies
Neurodegenerative Diseases