UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025869 |
|---|---|
| Receipt number | R000029744 |
| Scientific Title | Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease. Clinical study (intervention study). |
| Date of disclosure of the study information | 2017/02/15 |
| Last modified on | 2019/01/28 14:57:19 |
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Basic information
Public title
Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease. Clinical study (intervention study).
Acronym
Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease. Clinical study (intervention study).
Scientific Title
Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease. Clinical study (intervention study).
Scientific Title:Acronym
Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease. Clinical study (intervention study).
Region
| Japan |
Condition
Condition
Alzheimer disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effect of rivastigmine patch on gait disturbance in patients with Alzheimer disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gait speed, gait speed on dual task at 4weeks and 12 weeks after therapy.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
12 weeks
Rivastigmine patch
9mg and 18mg onece daily
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
| 50 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with Alzheimer disease
Key exclusion criteria
Patients with obvious motor disability
Patients who can not administer rivastigmine patch
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Shimura |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Neurology
Zip code
Address
2-1-1 Tomioka, Urayasu, Chiba 279-0021, Japan.
TEL
047-353-3111
miurashimura@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Shimura |
Organization
Juntendo University Urayasu Hospital
Division name
Department of Neurology
Zip code
Address
2-1-1 Tomioka, Urayasu, Chiba 279-0021, Japan.
TEL
047-353-3111
Homepage URL
miurashimura@yahoo.co.jp
Sponsor or person
Institute
Juntendo University Urayasu Hospital
Institute
Department
Personal name
Funding Source
Organization
ONO PHARMACEUTICAL CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 02 | Month | 15 | 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
| 2016 | Year | 12 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 16 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2018 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2018 | Year | 12 | Month | 03 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 27 | Day |
Last modified on
| 2019 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029744
