UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020115 |
|---|---|
| Receipt number | R000022133 |
| Scientific Title | Study of cognitive functions , BPSD and burden of care for caregivers in the additional dosage of the memantine hydrochloride for the Alzheimer's disease |
| Date of disclosure of the study information | 2015/12/08 |
| Last modified on | 2022/06/27 10:47:33 |
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Basic information
Public title
Study of cognitive functions , BPSD and burden of care for caregivers in the additional dosage of the memantine hydrochloride for the Alzheimer's disease
Acronym
the study of the additional dosage of the memantine hydrochloride
Scientific Title
Study of cognitive functions , BPSD and burden of care for caregivers in the additional dosage of the memantine hydrochloride for the Alzheimer's disease
Scientific Title:Acronym
the study of the additional dosage of the memantine hydrochloride
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine the inhibitory effect of the cognitive decline , the new onset of BPSD and the caregiver's burden, when I gave more of the memantine hydrochloride to the Alzheimer's disease patients taking the Acetylcholinesterase inhibitors already.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
BPSD
Evaluations are performed at baseline (month 0), and at month 3, 6 and 12.
Key secondary outcomes
cognitive function, caregiver's burden
Evaluations are performed at baseline (month 0), and at month 3, 6 and 12.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
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 disease patients
2. outpatient
3. treatment of acethylcholinesterase inhibitor for more than 6 months and unchanged dosage for 3 months recently
Key exclusion criteria
1. dementia patients except Alzheimer's disease
2. the patients who have severe mental disorders
3. the patients having the serious disease including the malignant neoplasm
4. the patients with a history of the hypersensitivity for memantine hydrochloride
5. In addition, the case that a principal investigator or subinvestigator judged to be inappropriate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihito Hayashi M.D., PhD. |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Division of Psychiatry, Department of Clinical Neuroscience,
Zip code
Address
5200 Kihara,Kiyotake-cho, Miyazaki, Japan
TEL
0985-85-1744
yoshih@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihito Hayashi M.D., PhD. |
Organization
Faculty of Medicine, University of Miyazaki
Division name
Division of Psychiatry, Department of Clinical Neuroscience,
Zip code
Address
5200 Kihara,Kiyotake-cho, Miyazaki, Japan
TEL
0985-85-1744
Homepage URL
yoshih@med.miyazaki-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, University of Miyazaki
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, University of Miyazaki
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
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
| 2015 | Year | 12 | Month | 08 | 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
Completed
Date of protocol fixation
| 2013 | Year | 12 | Month | 28 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 08 | Day |
Last modified on
| 2022 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022133
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
