UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012372 |
|---|---|
| Receipt number | R000014432 |
| Scientific Title | Evaluation of the tolerability of rivastigmine patch on patients with Alzheimer's disease |
| Date of disclosure of the study information | 2013/11/22 |
| Last modified on | 2015/12/21 10:26:41 |
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Basic information
Public title
Evaluation of the tolerability of rivastigmine patch on patients with Alzheimer's disease
Acronym
Evaluation of the tolerability of rivastigmine patch
Scientific Title
Evaluation of the tolerability of rivastigmine patch on patients with Alzheimer's disease
Scientific Title:Acronym
Evaluation of the tolerability of rivastigmine patch
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The evaluation of the tolerability of rivastigmine patch on Alzheimer's disease patients who titrated at short interval to the maintenace dose
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The evaluation of the safety, tolerability and adverse event(frequency of nausea and vomit, change of dietary intake) of rivastigmine patch in patients who titrated at short interval to the maintenace dose
Key secondary outcomes
ADAS-J cog
MMSE
Medication compliance
Change of caregiver burden
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients who titrated at 1-week intervals
Interventions/Control_2
Patients who titrated at 2-week intervals
Interventions/Control_3
Patients who titrated at 4-week intervals
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
| 50 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients by whom the concent in the document was got.
2)Patients who are 50 to 85 years old at the assesment of baseline
3)male or female without the possibility of pregnancy
4)Patients diagnosed as dementia of the Alzheimers type by the Diagnostic and Statistical Manual of Mental Disorders 4th edition criteria
5)Patients who diagnosed as probable AD according to the criteria of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimers Disease and Related Disorders Association criteria
6)MMSE at baseline of patients are 23 points or less and 10 or more points
7)Patients who were able to do normally reading, writing or spearking till before the onset of dementia
8)Patients who were cooperative and able to undergo medical tests and observation by oneself or with assisit of caregiver
9)Patients who have a caregiver throughout the study. The caregiver was required to be the primary caregiver and to be willing to accept responsibility for supervising the treatment, assessing the condition of the patient throughout the study and for providing input to efficacy assessments according
to protocol requirements.
Key exclusion criteria
1)patents who have the problem of urination
2)patients who have the skin disease
3)patients who have sight and hearing handicaps and an advanced speech impediment
4)patient whom the principal investigator or subinvestigator judged to be unsuitable as an object of this research
Target sample size
144
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shimada |
Organization
Graduate School of Medicine, Osaka City University
Division name
Geriatrics and Neurology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka city
TEL
06-6645-3889
h.shimada@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shimada |
Organization
Graduate School of Medicine, Osaka City University
Division name
Geriatrics and Neurology
Zip code
Address
1-4-3 Asahi-machi, Abeno-ku, Osaka city
TEL
06-6645-3889
Homepage URL
h.shimada@med.osaka-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medicine, Osaka City University
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 | 11 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 21 | Day |
Last modified on
| 2015 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014432
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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