UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012340 |
|---|---|
| Receipt number | R000014281 |
| Scientific Title | Examnitaion of the primary prevention effect of BPSD in the additional dosage of the mementine hydrochloride for the Alzheimer's disease |
| Date of disclosure of the study information | 2013/11/22 |
| Last modified on | 2015/12/21 10:26:04 |
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Basic information
Public title
Examnitaion of the primary prevention effect of BPSD in the additional dosage of the mementine hydrochloride for the Alzheimer's disease
Acronym
the study of the additional dosage of the mementine hydrochloride
Scientific Title
Examnitaion of the primary prevention effect of BPSD in the additional dosage of the mementine hydrochloride for the Alzheimer's disease
Scientific Title:Acronym
the study of the additional dosage of the mementine hydrochloride
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology | Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the inhibitory effect of the new onset of BPSD, when I gave more of the memantine hydrochloride to the ALzheimer's disease patienta taking the Acetylcholinesterase inhibitor.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
BPSD
Key secondary outcomes
Cognitive function
Safety
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 not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
acetylcholinesterase inhibitor
Interventions/Control_2
acetylcholinesterase inhibitor and memantine
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
1. the moderate to severe Alzheimer's desease patients
2. the patients who have no BPSD and the treatment of acetylcholinesterase inhibitor for more than 9 months
3. the patients who meat DSM-4 and NINCDS-ADRDA the criteria for Alzheimer's desease
Key exclusion criteria
1.dementia patients except Alzheimer's desease
2.the patients who have severe mental desorder
3.the patients having the serious disease including the malignant neoplasm
4.the patients with a history of the hypersensitivity for memantine hydrochloride
5.the patients who corresponds to a contraindication in an attached document
6.In addition, the case that a principal investigator or subinvestigator judged to be inappropriate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shimada. M.D ., PhD. |
Organization
Osaka City University Graduate school of Medicine
Division name
Geriatric Medicine
Zip code
Address
Asahimachi 1-4-3, Abeno-ku, Osaka, 545-8585 Japan
TEL
06-6645-3889
h.shimada@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Shimada. M.D ., PhD. |
Organization
Osaka City University Graduate school of Medicine
Division name
Geriatric Medicine
Zip code
Address
Asahimachi 1-4-3, Abeno-ku, Osaka, 545-8585 Japan
TEL
06-6645-3889
Homepage URL
h.shimada@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University Graduate school of Medicine
Institute
Department
Personal name
Funding Source
Organization
Osaka City University Graduate school of Medicine
Organization
Division
Category of Funding Organization
Local Government
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 | 11 | Month | 22 | 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
| 2012 | Year | 12 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | 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 | 11 | Month | 19 | Day |
Last modified on
| 2015 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014281
