UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027492 |
|---|---|
| Receipt number | R000030941 |
| Scientific Title | Studies on changes in serum butyrylcholinesterase activity of rivastigmine transdermal preparation in Alzheimer's type dementia patients and its effect on cognitive function, lipid / blood pressure / sugar metabolism |
| Date of disclosure of the study information | 2017/05/25 |
| Last modified on | 2019/03/29 11:50:04 |
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Basic information
Public title
Studies on changes in serum butyrylcholinesterase activity of rivastigmine transdermal preparation in Alzheimer's type dementia patients and its effect on cognitive function, lipid / blood pressure / sugar metabolism
Acronym
Study on serum butyrylcholinesterase activity of rivastigmine transdermal preparation in patients with Alzheimer type dementia
Scientific Title
Studies on changes in serum butyrylcholinesterase activity of rivastigmine transdermal preparation in Alzheimer's type dementia patients and its effect on cognitive function, lipid / blood pressure / sugar metabolism
Scientific Title:Acronym
Study on serum butyrylcholinesterase activity of rivastigmine transdermal preparation in patients with Alzheimer type dementia
Region
| Japan |
Condition
Condition
Altzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Measurement of serum BuChE and an influential presence to a recognition function change, fat matter, low blood and sugar metabolism of an Alzheimer-type recognition shou patient before and after rivastigmine transdermal preparation are considered.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in serum BuChE activity, change in cognitive function severity evaluation (MMSE, ADAS-J) at registration, 3 months after administration, 6 months after administration
Key secondary outcomes
TG, LDL, HDL, HbA1c, GOT, GPT, pancreatic amylase, MRI (VSRAD), blood pressure, pulsatility at the time of registration, 3 months after administration, 6 months after administration
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Rivastigmine group: Rivastatch patch 9 mg, Rivasutatch patch 18 mg
Among the dosage and dose stated in the package insert, administration starts from 9 mg once a day, in principle, it increases to 18 mg once a day after 4 weeks.
Interventions/Control_2
Donepezil hydrochloride group: Regardless of the dosage form, it should be 10 mg or less.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with mild and moderate Alzheimer's type dementia with complications of either hyperlipidemia, hypertension, or diabetes.
Key exclusion criteria
Patients with history of hypersensitivity to rivastigmine, components of donepezil hydrochloride or carbamate derivatives
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Kudoh |
| Middle name | |
| Last name | Chiaki |
Organization
Medical Corporation Kudoh Chiaki Neurosurgery Clinic
Division name
Neurosurgery
Zip code
143-0016
Address
1-23-10 Omoriokita, Ota-ku, Tokyo 143-0016
TEL
03-5767-0226
kudouchiaki@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Kudoh |
| Middle name | |
| Last name | Chiaki |
Organization
Medical Corporation Kudoh Chiaki Neurosurgery Clinic
Division name
Neurosurgery
Zip code
143-0016
Address
1-23-10 Omoriokita, Ota-ku, Tokyo 143-0016
TEL
03-5767-0226
Homepage URL
kudouchiaki@yahoo.co.jp
Sponsor or person
Institute
Medical Corporation Kudoh Chiaki Neurosurgery Clinic
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
Mizuo Clinic Ethics Review Committee
Address
Wisteria-kan1F,3-9-1,Nakataminami,Izumi-ku,Yokohama-shi,Kanagawa,Japan
Tel
03-5413-8929
info@mizuo-irb.jp
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
医療法人社団くどうちあき脳神経外科クリニック（東京都)/Medical Corporation Kudoh Chiaki Neurosurgery Clinic(Tokyo)
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 25 | 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
31
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
| 2017 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2017 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 25 | Day |
Last modified on
| 2019 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030941
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
