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
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
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
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
