UMIN-CTR Clinical Trial

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
Last 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
Email	kudouchiaki@yahoo.co.jp

Public contact
1st 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
Email	kudouchiaki@yahoo.co.jp

Sponsor
Institute	Medical Corporation Kudoh Chiaki Neurosurgery Clinic
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030941