UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia.
Title of the study (Brief title)	Donepezil study on Parkinson\'s disease with dementia
Region	Japan

Condition
Condition	Parkinson's disease
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effect on cognitive function and phychological symtom
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	UPDRS,MMSE
Key secondary outcomes

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	donepezil
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 with Parkinson's disease and were noticed to have symptoms of dementia. 1)Outpatients of Department of Neurology, Kansai Medical University. 2)Those who aggreed to participate in this study
Key exclusion criteria	1)Patients or their families disagreed to this study 2)Who have been already treated with anti-dementia drugs. 3)Past medical history of severe neurological or psychological disorders (brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, head injury associated with loss of consciousness, neurosurgery with residual symptoms). 4)Who have been regarded to be inappropriate to participate in the study.
Target sample size	50

Research contact person
Name of lead principal investigator	Satoshi Kaneko
Organization	Kansai Medical University
Division name	Department of Neurology
Address	2-5-1 Shinmachi, Hirakata
TEL	072-804-2542
Email	kanekosa@takii.kmu.ac.jp

Public contact
Name of contact person	Satoshi Kaneko
Organization	Kansai Medical University
Division name	Department of Neurology
Address	2-5-1 Shinmachi, Hirakata
TEL	072-804-2542
Homepage URL
Email	kanekosa@takii.kmu.ac.jp

Sponsor
Institute	Kansai Medical University
Institute
Department

Funding Source
Organization	Kansai Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	None

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 17 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 05 Month 17 Day
Anticipated trial start date	2013 Year 05 Month 17 Day
Last follow-up date	2015 Year 05 Month 16 Day
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	2013 Year 05 Month 17 Day
Last modified on	2017 Year 05 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012567