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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000012372
Receipt No. 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

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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
Email 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
Email h.shimada@med.osaka-cu.ac.jp

Sponsor
Institute Graduate School of Medicine, Osaka City University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014432

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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