UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010752
Receipt number 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 15:28:34

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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 or person

Institute

Kansai Medical University

Institute

Department

Personal name



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

Value
https://center6.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