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Intensive Instruction on the Use of Aricept

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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.

Tracking Information
First Submitted Date  ICMJE October 24, 2013
First Posted Date  ICMJE October 30, 2013
Results First Submitted Date  ICMJE September 20, 2018
Results First Posted Date  ICMJE June 3, 2019
Last Update Posted Date June 3, 2019
Study Start Date  ICMJE September 2013
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2019)
Number of Participants With Medication Continuation [ Time Frame: 48 weeks ]
Number of Participants who Continue the Medication for 48 weeks
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
  • Medication persistence rate [ Time Frame: 48 weeks ]
  • Reasons for discontinuation [ Time Frame: 48 weeks ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2019)
  • Reasons for Discontinuation [ Time Frame: 48 weeks ]
    Reasons for discontinuation of the Medication
  • 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
  • Adverse Events [ Time Frame: Week 2, 12, 24, 48 ]
    Adverse Events for each arm
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2013)
  • Factor analysis for medication persistence [ Time Frame: 48 weeks ]
    Subgroup analysis with delineation of different factors associated with the degree of medication persistence with Aricept therapy: years of schooling, family living together, caregiver background, Category of Condition of Need for Long-Term Care, In-Home Long-Term Care Service, FAST, MMSE-J, the Level fo Independent Living of Demented Elderly, concomitant medication, BPSD, drug compliance
  • Adverse Events [ Time Frame: Week 2, 12, 24, 48 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intensive Instruction on the Use of Aricept
Official Title  ICMJE A Study About the Impact of Intensive Instruction on the Use of Aricept and the Reasons for Discontinuation in Patients With Alzheimer's Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Type Dementia
Intervention  ICMJE
  • Behavioral: Intensive adherence instruction
    Instruction with educational brochure
  • Behavioral: Control
    Instruction as per usual practice
Study Arms  ICMJE
  • Experimental: Intensive adherence instruction
    Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure
    Intervention: Behavioral: Intensive adherence instruction
  • Sham Comparator: Control
    The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.
    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2019)
125
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2013)
150
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01972204
Other Study ID Numbers  ICMJE ART-2013-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Tetsumasa Kamei, Mirai Iryo Research Center, Inc.
Study Sponsor  ICMJE Mirai Iryo Research Center, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tetsumasa Kamei Shonan Fujisawa Tokushukai Hospital
PRS Account Mirai Iryo Research Center, Inc.
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP