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Intensive Instruction on the Use of Aricept

M

Mirai Iryo Research Center, Inc.

Status

Completed

Conditions

Alzheimer's Type Dementia

Treatments

Behavioral: Control
Behavioral: Intensive adherence instruction

Study type

Interventional

Funder types

Other

Identifiers

NCT01972204
ART-2013-01

Details and patient eligibility

About

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.

Full 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.

Enrollment

125 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

125 participants in 2 patient groups

Intensive adherence instruction
Experimental group
Description:
Intensive adherence instruction group will receive 5 visits and receive the instruction on the use of Aricept with educational brochure
Treatment:
Behavioral: Intensive adherence instruction
Control
Sham Comparator group
Description:
The control group will receive 5 visits and receive the instruction on the use of Aricept as per usual practice.
Treatment:
Behavioral: Control

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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