UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000010752
Receipt No. R000012567
Scientific Title A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia.
Date of disclosure of the study information 2013/05/17
Last modified on 2017/05/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia.
Acronym Donepezil study on Parkinson\'s disease with dementia
Scientific Title A study on usefulness and safety of donepezil for cognitive function and phychological symptoms of patients with Parkinson's disease and Alzheimer type dementia.
Scientific Title:Acronym 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
1st name
Middle name
Last name Satoshi Kaneko
Organization Kansai Medical University
Division name Department of Neurology
Zip code
Address 2-5-1 Shinmachi, Hirakata
TEL 072-804-2542
Email kanekosa@takii.kmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Kaneko
Organization Kansai Medical University
Division name Department of Neurology
Zip code
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)

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
2013 Year 05 Month 17 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 Terminated
Date of protocol fixation
2013 Year 05 Month 17 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000012567

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.