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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027818
Receipt No. 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

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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
Institute Kagawa University School of Medicine
Institute
Department

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
URL(English) https://upload.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


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