UMIN-CTR Clinical Trial

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
Last 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
1st 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