UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041148 |
|---|---|
| Receipt number | R000046992 |
| Scientific Title | Effects of rivastigmine on cognitive function and appetite. |
| Date of disclosure of the study information | 2020/07/20 |
| Last modified on | 2020/07/18 14:03:05 |
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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
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
hamano@u-fukui.ac.jp
Sponsor or person
Institute
Second Department of Internal Medicine, Faculty of Medical Scieces, University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046992
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