UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010842 |
|---|---|
| Receipt number | R000012695 |
| Scientific Title | Investigation on efficacy and safety of rivastigmin patch in patients switched from donepezil with mild to moderate Alzheimer's disease |
| Date of disclosure of the study information | 2013/05/30 |
| Last modified on | 2018/12/03 11:03:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Investigation on efficacy and safety of rivastigmin patch in patients switched from donepezil with mild to moderate Alzheimer's disease
Acronym
Efficacy and safety of rivastigmin patch in patients switched from donepezil
Scientific Title
Investigation on efficacy and safety of rivastigmin patch in patients switched from donepezil with mild to moderate Alzheimer's disease
Scientific Title:Acronym
Efficacy and safety of rivastigmin patch in patients switched from donepezil
Region
| Japan |
Condition
Condition
mild to moderate Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the efficacy and safety of rivastigmin patch in patients switched from donepezil.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes from baseline at week 24 on Clinical Global Impression of Change(CGIC)
Key secondary outcomes
Changes from baseline at week 24 on caregiver-rated modified Crichton scale(CMCS)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients 1) who are mild to moderate Alzheimer's disease, 2) who take donepezil 3 to 5mg/day more than 3 months, 3) who show a poor response to donepezil, poor medication adherence due to dysphagia or adverse effects, or hope for switch to transdermal patch, and 4) who understand the points of this study and give informed-consent in literature.
Key exclusion criteria
1)Patients who correspond to the administration contraindication of the objective drug
2)Patients inadequate for the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yu Nakamura |
Organization
Kagawa University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
0878912167
sdanjo@med.kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sonoko Danjo |
Organization
Kagawa University School of Medicine
Division name
Department of Neuropsychiatry
Zip code
Address
1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL
0878912167
Homepage URL
sdanjo@med.kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kagawa University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To observe efficacy and safety of rivastigmin patch in patients switched from donepezil
Management information
Registered date
| 2013 | Year | 05 | Month | 30 | Day |
Last modified on
| 2018 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012695
