UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation on efficacy and safety of rivastigmin patch in patients switched from donepezil with mild to moderate Alzheimer's disease
Title of the study (Brief title)	Efficacy and safety of rivastigmin patch in patients switched from donepezil
Region	Japan

Condition
Condition	mild to moderate Alzheimer's disease
Classification by specialty	Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to investigate the efficacy and safety of rivastigmin patch in patients switched from donepezil.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes from baseline at week 24 on Clinical Global Impression of Change(CGIC)
Key secondary outcomes	Changes from baseline at week 24 on caregiver-rated modified Crichton scale(CMCS)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients 1) who are mild to moderate Alzheimer's disease, 2) who take donepezil 3 to 5mg/day more than 3 months, 3) who show a poor response to donepezil, poor medication adherence due to dysphagia or adverse effects, or hope for switch to transdermal patch, and 4) who understand the points of this study and give informed-consent in literature.
Key exclusion criteria	1)Patients who correspond to the administration contraindication of the objective drug 2)Patients inadequate for the study
Target sample size	100

Research contact person
Name of lead principal investigator	Yu Nakamura
Organization	Kagawa University School of Medicine
Division name	Department of Neuropsychiatry
Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL	0878912167
Email	sdanjo@med.kagawa-u.ac.jp

Public contact
Name of contact person	Sonoko Danjo
Organization	Kagawa University School of Medicine
Division name	Department of Neuropsychiatry
Address	1750-1 Ikenobe, Miki, Kita, Kagawa 761-0793, Japan
TEL	0878912167
Homepage URL
Email	sdanjo@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa University School of Medicine
Institute
Department

Funding Source
Organization	Kagawa University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
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	2013 Year 05 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 31 Day
Anticipated trial start date	2013 Year 05 Month 30 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	To observe efficacy and safety of rivastigmin patch in patients switched from donepezil

Management information
Registered date	2013 Year 05 Month 30 Day
Last modified on	2018 Year 12 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012695