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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015596
Receipt No. 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

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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
Last 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
Email kuroda-a@po2.synapse.ne.jp

Public contact
1st 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
Email takayama@soiken.com

Sponsor
Institute Ichihino Memorial Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018061

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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