Intensive Instruction on the Use of Aricept

NCT01972204 | Completed Results

• 1 other identifier: ART-2013-01
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer's Type Dementia

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Medication Continuation

  Number of Participants who Continue the Medication for 48 weeks

  48 weeks

Secondary Outcomes (3)

• Reasons for Discontinuation

  48 weeks

• Number of Participants With Medication Discontinuation Due to Change to Alicept or Generics

  48 weeks

• Adverse Events

  Week 2, 12, 24, 48

Study Arms (2)

Intensive adherence instruction

EXPERIMENTAL

Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure

Behavioral: Intensive adherence instruction

Control

SHAM COMPARATOR

The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.

Behavioral: Control

Interventions

Intensive adherence instruction BEHAVIORAL

Instruction with educational brochure

Intensive adherence instruction

Control BEHAVIORAL

Instruction as per usual practice

Control

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mirai Iryo Research Center, Inc.: lead

Study Sites (1)

Shonan Fujisawa Tokushukai Hospital

Fujisawa, Kanagawa, Japan

Location

Results Point of Contact

• Title: Tomoko Machida (Director)
• Organization: Mirai Iryo Research Center

machida@mirai-iryo.com

81-3-3263-4801

Study Officials

• Tetsumasa Kamei

  Shonan Fujisawa Tokushukai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital Director

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: October 30, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 3, 2019
• Results First Posted: June 3, 2019

Record last verified: 2019-02

Locations

JP (1)