UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005883 |
|---|---|
| Receipt number | R000006942 |
| Scientific Title | The effect of combination therapy of Donepezil and Memary for moderate to severe Alzheimer's disease |
| Date of disclosure of the study information | 2011/09/01 |
| Last modified on | 2017/07/03 18:53:22 |
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Basic information
Public title
The effect of combination therapy of Donepezil and Memary for moderate to severe Alzheimer's disease
Acronym
The effect of combination therapy of Donepezil and Memary for moderate to severe Alzheimer's disease
Scientific Title
The effect of combination therapy of Donepezil and Memary for moderate to severe Alzheimer's disease
Scientific Title:Acronym
The effect of combination therapy of Donepezil and Memary for moderate to severe Alzheimer's disease
Region
| Japan |
Condition
Condition
moderate to severe Alzheimer's disease
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine both usefulness and safety about combination therapy of Donepezil and Memantine.
Basic objectives2
Others
Basic objectives -Others
We will utilize the results mentioned above for the new strategic drug therapy for the patients of Alzheimer's disease.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
We will carry out tree contents of SIB, FAST and MMSE for 3 times at every 12 week-point during 24 weeks from the start-point of medication and evaluate the results of usefulness.
Key secondary outcomes
We will carry out two contents of NPI-D and ADCS-ADL for 3 times at every 12 week-point during 24 weeks from the start-point of medication and evaluate the results of usefulness.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A;At first, donepezil (10mg/day) for 24weeks continuously. Memantine is added at 5mg/day (W13)to 20mg/day at W16 (+5mg/day per every 1 week). As a result, donepezil (10mg/day) +memantine (20mg/day) from W16 to W24.
The number of times of medication: 1/day
Interventions/Control_2
Group B;At first, donepezil is fixed at 5mg/day continuously from W1 to W13. And from W14 to W24, donepezil is up to 10mg/day. Memantine start from W1 at 5mg/day and adding up to 20mg/day at W4 (+5mg/day per every 1 week). As a result, from W4 to W24, memantine is continuously fixed at 20mg/day.
As a result, donepezil (10mg/day) +memantine (20mg/day) from W13 to W24.
The number of times of medication: 1/day
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Inclusion Criteria:Diagnosed as Alzheimer's disease with DSM-4.
Severity of dementia: FAST5-6.
Medication: Donepezil 5mg/day >=6 months continuously as stable.
Key exclusion criteria
Patients with contraindication for donepezil or/and memantine.
Patients who is judged as inappropriate for entry to this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | YASUJI YAMAMOTO |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
7-5-2, Kusuniki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6065
yamay@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | YASUJI YAMAMOTO |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
7-5-2, Kusuniki-cho, Chuo-ku, Kobe, Hyogo
TEL
078-382-6065
Homepage URL
yamay@med.kobe-u.ac.jp
Sponsor or person
Institute
YASUJI YAMAMOTO
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
神戸大学附属病院（兵庫県神戸市）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 01 | 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
| 2011 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 07 | Month | 03 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 29 | Day |
Last modified on
| 2017 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006942
