UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015596 |
|---|---|
| Receipt number | R000018061 |
| Scientific Title | Effects of rivastigmine on the appetite of patients with Alzheimer's disease (Relationship of BuChE activity and ghrelin level in blood) |
| Date of disclosure of the study information | 2014/11/04 |
| Last modified on | 2019/03/04 18:20:48 |
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Basic information
Public title
Effects of rivastigmine on the appetite of patients with Alzheimer's disease (Relationship of BuChE activity and ghrelin level in blood)
Acronym
Effects of rivastigmine on the appetite of patients with Alzheimer's disease (Relationship of BuChE activity and ghrelin level in blood)
Scientific Title
Effects of rivastigmine on the appetite of patients with Alzheimer's disease (Relationship of BuChE activity and ghrelin level in blood)
Scientific Title:Acronym
Effects of rivastigmine on the appetite of patients with Alzheimer's disease (Relationship of BuChE activity and ghrelin level in blood)
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate improvement of the appetite and symptoms in patients with AD (Alzheimer's disease) using rivastigmine to suppress the degradation of ghrelin
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
* Amount of change of blood active and inactive ghrelin
* Change of BuChE activity
Key secondary outcomes
* Mean amount of weekly food intake
* Amount of change of body weight
* Psychological attitude including appetite
* Cognitive ability assessed by HDS-R
* Adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention of medicine,
1. Patients will be started using 4.5mg rivastigmine, and will be increased 4.5mg additionally every four weeks until a maintenance dose is reached. Maintenance dose is 18mg per day in this study.
2. Using donepezil and/or galanthamine together with rivastigmine is prohibited.
3. Using new medicine in addition to previous prescription is prohibited.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Those who fall into the following criteria will be included in this study:
1) Patients themselves or their proxies
can voluntarily provide informed
consent to participate in this study
2) At age of 50 or older
3) Patients meet the probable AD criteria
(using NIA-AA, 2011), and are
diagnosed as having mild or moderate
Alzheimer's disease
4) Either untreated or treated with
medication for AD (using donepezil,
galanthamine, or memantine) and
willing to use rivastigmine instead,
and meet one of the following
conditions:
a) using the medicine over a half
year, but shows no improvement in
symptoms
b) experiencing side effects such as
nausea, vomiting, or diarrhea for
a long period of time and hard to
continue with the medication, or
c) experiencing a decrease in
medication compliance.
Key exclusion criteria
Patients who fall into one of the following criteria will be excluded from this study:
1) Patients with neurodegenerative
disease, schizophrenia, bipolar
disorder, or other disease classified
in DSM-IV Axis I
2) Patients with DLB, or other systemic
disease or neurological disorder
(dysthyroidism, vitamin B12 or folic
acid deficiency, after head injury,
Huntington disease, Parkinson's
disease, intradural hematoma, normal
pressure hydrocephalus, brain tumor,
syphilis, etc.)
3) Patients diagnosed as having VD, or
possible VD based on NINDS-AIREN
diagnostic criteria
4) Patients with severe cardiovascular
disorder
5) Patients with bradycardia
(< 50bpm), sick sinus syndrome, or
conduction disturbance
6) Patients with acute, severe, or
unstable symptoms of asthma
7) Patients showing hypersensitiveness to
components of rivastigmine or to
carbamate derivative
8) Patients after operation of gastrectomy
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kuroda Atsushi |
Organization
Ichihino Memorial Hospital
Division name
Division of Cardiovascular Medicine
Zip code
Address
3079 Hiwaki-Cho Ichihino, Satsuma Sendai-shi, Kagoshima-ken 895-1203
TEL
0996-38-1200
kuroda-a@po2.synapse.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroki Takayama |
Organization
Soiken Inc.
Division name
Support Business for Clinical Research on Medicines
Zip code
Address
4th Floor NBF Ogawa Bld., 1-3-1 Ogawamachi, Kanda, Chiyoda-ku, Tokyo 101-0052
TEL
03-3295-1350
Homepage URL
takayama@soiken.com
Sponsor or person
Institute
Ichihino Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., LtD.
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
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
| 2014 | Year | 11 | Month | 04 | 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
| 2014 | Year | 11 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 11 | Month | 04 | Day |
Last modified on
| 2019 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018061
