UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011222 |
|---|---|
| Receipt number | R000013130 |
| Scientific Title | Randomized, an open controlled trial of memantine in moderate Alzheimer's disease already receiving cholinesterase inhibitors. |
| Date of disclosure of the study information | 2013/07/18 |
| Last modified on | 2017/11/14 21:04:33 |
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Basic information
Public title
Randomized, an open controlled trial of memantine in moderate Alzheimer's disease already receiving cholinesterase inhibitors.
Acronym
Randomized, an open controlled trial of memantine in moderate Alzheimer's disease already receiving cholinesterase inhibitors.
Scientific Title
Randomized, an open controlled trial of memantine in moderate Alzheimer's disease already receiving cholinesterase inhibitors.
Scientific Title:Acronym
Randomized, an open controlled trial of memantine in moderate Alzheimer's disease already receiving cholinesterase inhibitors.
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Psychiatry | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine efficacy and safety of combination therapy of memantine and cholinesterase inhibitors.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Mini-Mental State Examination
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Interventions
donepezil + memantine 20mg/day, 52week
Interventions/Control_2
Interventions
galantamine + memantine 20mg/day, 52week
Interventions/Control_3
Interventions
rivastigmine + memantine 20mg/day, 52week
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
Diagnosis; Diagnostic and Statistical Manual of Mental Disorders 4 Text Revision or National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association.
Outpatient or inpatient.
Key exclusion criteria
cardiac failure, epilepsia,creatinine clearance 30>, other serious physical disease.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Iwata Nakao |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
98-2 Dengakugakubo, Kutukake-cho, Toyoake-shi, Aichi-ken, Japan
TEL
0562939250
nakao@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Matsunaga |
Organization
Fujita Health University School of Medicine
Division name
Department of Psychiatry
Zip code
Address
98-2 Dengakugakubo, Kutukake-cho, Toyoake-shi, Aichi-ken, Japan
TEL
0562939250
Homepage URL
shinjim@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University School of Medicine, Department of Psychiatry
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 18 | 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
| 2013 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 18 | Day |
Last modified on
| 2017 | Year | 11 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013130
