UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027818
Receipt number R000031872
Scientific Title A study on quantitative electroencephalography of Alzheimer's disease patients in combination with donepezil and memantine and each single administration
Date of disclosure of the study information 2017/06/19
Last modified on 2019/04/11 15:47:39

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Basic information

Public title

A study on quantitative electroencephalography of Alzheimer's disease patients in combination with donepezil and memantine and each single administration

Acronym

A study on quantitative electroencephalography of Alzheimer's disease patients in combination with donepezil and memantine and each single administration

Scientific Title

A study on quantitative electroencephalography of Alzheimer's disease patients in combination with donepezil and memantine and each single administration

Scientific Title:Acronym

A study on quantitative electroencephalography of Alzheimer's disease patients in combination with donepezil and memantine and each single administration

Region

Japan


Condition

Condition

Alzheimer's disease

Classification by specialty

Psychiatry

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We analyze changes in quantitative electroencephalography before administration and after 3 months of administration for cases where donepezil or memantine is administered alone or in combination with Alzheimer's disease patients.

Basic objectives2

Others

Basic objectives -Others

We investigate changes in MMSE, NPI, the Epworth sleepiness scales before administration and 3 months after administration for cases where donepezil or memantine is administered alone or in combination with Alzheimer's disease patients.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Changes on the quantitative electroencephalography three months after donepezil or memantine administration.

Key secondary outcomes



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

A patient diagnosed as having dementia due to Alzheimer's disease at DSM-5 and whose treatment necessitates the initiation of donepezil or memantine alone. Or a patient who has been administered one of each of donepezil or memantine, and another one is newly administered additionally.

Key exclusion criteria

1.A case of complication of other dementia or psychiatric disorder.
2.Cases with significant physical complications.

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Norifumi
Middle name
Last name TSUNO

Organization

Kagawa University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

761-0793

Address

1750-1,Ikenobe,Miki-cho,Kita-gun,Kagawa,761-0793,JAPAN

TEL

087-891-2167

Email

tsuno@med.kagawa-u.ac.jp


Public contact

Name of contact person

1st name Takahiro
Middle name
Last name MORI

Organization

Kagawa University School of Medicine

Division name

Department of Neuropsychiatry

Zip code

761-0793

Address

1750-1,Ikenobe,Miki-cho,Kita-gun,Kagawa,761-0793,JAPAN

TEL

087-891-2167

Homepage URL


Email

tmori@med.kagawa-u.ac.jp


Sponsor or person

Institute

Kagawa University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kagawa University School of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

ethics committee of the Kagawa University School of Medicine

Address

1750-1,Ikenobe,Miki-cho,Kita-gun,Kagawa,761-0793,JAPAN

Tel

087-891-2011

Email

chosa@med.kagawa-u.ac.jp


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

2017 Year 06 Month 19 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

48

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

Completed

Date of protocol fixation

2016 Year 01 Month 08 Day

Date of IRB

2016 Year 01 Month 08 Day

Anticipated trial start date

2016 Year 02 Month 26 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Everyone who met the selection criteria in February 2016 - December 2018 patients who visited our facility or related facilities


Management information

Registered date

2017 Year 06 Month 19 Day

Last modified on

2019 Year 04 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031872


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name