UMIN-CTR Clinical Trial

Basic information
Public title	Effects of rivastigmine on cognitive function and appetite.
Acronym	Effects of rivastigmine on cognitive function and appetite.
Scientific Title	Effects of rivastigmine on cognitive function and appetite.
Scientific Title:Acronym	Effects of rivastigmine on cognitive function and appetite.
Region	Japan

Condition
Condition	Alzheimer's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Weight loss increases dementia risk and promotes dementia progression. Acetylcholinesterase (AChE) inhibitor, which is a dementia drug, has a side effect of decreased appetite, but rivastigmine, which also has butyrylcholinesterase (BChE) inhibitory action, has been reported to increase appetite. This may be related to the conversion of ghrelin, which acts on appetite enhancement, from active form to inactive form by BChE. To evaluate the relationship between cognitive function and appetite in AD patients by rivastigmine by conducting appetite questionnaire (JSNAQ) at the Fukui University Hospital, before and after administration of rivastigmine patch.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Appetite Questionnaire (JSNAQ) (at the start of the test, 3, 6 and 12 months)
Key secondary outcomes	MMSE-J (cognitive function evaluation) (at the start of the test, 3, 6 and 12 months) ADAS-Jcog (cognitive function evaluation) (at the start of the study, 3, 6, and 12 months)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Administration of rivastigmine patch to untreated Alzheimer-type dementia patients will be started.
Interventions/Control_2	Patients currently receiving other cholinesterase inhibitors (donepezil, galantamine) will switch to rivastigmine.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Targets and planned number of studies A total of 50 Alzheimer's dementia patients living in Fukui Prefecture (2) Place of implementation Fukui University Hospital Target patients who meet all of the following criteria: 1 Alzheimer-type dementia patients diagnosed as mild and moderate 2 Patients aged 50 to 85 at the time of obtaining consent 3 Patients who can be accompanied by a caregiver at the time of examination 4 Patients (or legal representatives) who can obtain written informed consent to participate in this study 5. Patients who were informed by carers regarding their participation in this study.
Key exclusion criteria	Patients who have any of the following are excluded. 1. Patients who participated in other clinical trials within 4 months 2. Other patients who the investigator determined to be unsuitable for study
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Tadanori Middle name Last name Hamano
Organization	university of Fukui
Division name	Faculty of Medical Sciences, Second Department of Internal Medicine
Zip code	910-1193
Address	23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
TEL	0776-61-3111
Email	hamano@u-fukui.ac.jp

Public contact
Name of contact person	1st name Tadanori Middle name Last name Hamano
Organization	University of Fukui
Division name	Faculty of Medical Sciecnes, Second Department of Internal Medicine, University of Fukui
Zip code	910-1193
Address	23-3 Matsuokashimoaizuki, Eiheji-cho, Yoshida-gun, Fukui
TEL	0776-61-3111
Homepage URL
Email	hamano@u-fukui.ac.jp

Sponsor
Institute	Second Department of Internal Medicine, Faculty of Medical Scieces, University of Fukui
Institute
Department

Funding Source
Organization	Second Department of Internal Medicine, Faculty of Medical Scieces, University of Fukui
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of Fukui
Address	23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui
Tel	0776-61-3111
Email	hamano@u-fukui.ac.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	福井大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 20 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	0
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	Open public recruiting
Date of protocol fixation	2017 Year 06 Month 30 Day
Date of IRB	2017 Year 06 Month 30 Day
Anticipated trial start date	2017 Year 06 Month 30 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry	2022 Year 03 Month 31 Day
Date trial data considered complete	2022 Year 03 Month 31 Day
Date analysis concluded	2022 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 07 Month 18 Day
Last modified on	2020 Year 07 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046992