UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of rivastigmine on the appetite of patients with Alzheimer's disease (Relationship of BuChE activity and ghrelin level in blood)
Title of the study (Brief title)	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	Kuroda Atsushi
Organization	Ichihino Memorial Hospital
Division name	Division of Cardiovascular Medicine
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
Name of contact person	Hiroki Takayama
Organization	Soiken Inc.
Division name	Support Business for Clinical Research on Medicines
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 11 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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