Unique ID issued by UMIN | UMIN000012617 |
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Receipt number | R000014751 |
Scientific 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 |
Date of disclosure of the study information | 2013/12/18 |
Last modified on | 2018/06/07 12:43:59 |
A study about the impact of intensive instruction on the use of Aricept and the reasons for discontinuation in patients with Alzheimer's Disease
A study about the impact of intensive instruction on the use of Aricept and the reasons for discontinuation in patients with Alzheimer's Disease
A study about the impact of intensive instruction on the use of Aricept and the reasons for discontinuation in patients with Alzheimer's Disease
A study about the impact of intensive instruction on the use of Aricept and the reasons for discontinuation in patients with Alzheimer's Disease
Japan |
Alzheimer's Disease
Neurology |
Others
NO
To examine the influence of the instruction on the use of Aricept with educational brochure on the 48-wks medication persistence
To assess the reasons for discontinuation
Efficacy
Confirmatory
Pragmatic
Not applicable
Medication persistence rate at 48 weeks
Reasons for discontinuation
Factor analysis for medication persistence
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
No treatment
NO
NO
Institution is considered as a block.
YES
Central registration
2
Educational,Counseling,Training
Behavior,custom |
Intensive adherence instruction with educational brochure
Adherence instruction as per usual practice
Not applicable |
Not applicable |
Male and Female
1) Diagnostic evidence of probable Alzheimer's type Dementia consistent with DSM-IV
2) Written informed consent will be obtained from the subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities
3) Patients having caregivers who submit written consent for cooperative involvements in this study, can provide patients' information necessary for this study, assist treatment compliance, and escort patients on required visits to study institution
4) Outpatients in their own home
1) Patients treated with donepezil, galantamine, rivastigmine in 4 weeks immediately before enrollment
2) Known hypersensitivity to donepezil or piperadine derivatives
3) Involvement in any other investigational drug clinical trial during the preceding 12 weeks
150
1st name | |
Middle name | |
Last name | Tetsumasa Kamei |
Shonan Fujisawa Tokushukai Hospital
Department of Neurology
Tsujidoukamidai 1-5-1 Fujisawa-City, Kanagawa, Japan
0466-35-1177
tetsumasakam@ctmc.jp
1st name | |
Middle name | |
Last name | Tomoko Machida |
Mirai Iryo Research Cneter Inc,
Clinical Research Administration Sec.
Emina Building 3F, 1-8-7, Koji-machi, Chiyoda-ku, Tokyo, Japan 102-0083
03-3263-4801
http://www.mirai-iryo.com/
machida@mirai-iryo.com
Shonan Fujisawa Tokushukai Hospital
Eisai Co., Ltd.
Profit organization
Japan
YES
NCT01972204
ClinicalTrials.gov
2013 | Year | 12 | Month | 18 | Day |
Unpublished
Completed
2013 | Year | 09 | Month | 05 | Day |
2013 | Year | 10 | Month | 10 | Day |
2017 | Year | 08 | Month | 28 | Day |
2017 | Year | 12 | Month | 21 | Day |
2013 | Year | 12 | Month | 18 | Day |
2018 | Year | 06 | Month | 07 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014751
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