UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004325 |
|---|---|
| Receipt number | R000005166 |
| Scientific Title | The efficacy and safety of Yokukansan for BPSD in Alzheimer's disease. a randomized, double-blind, placebo-control trial. |
| Date of disclosure of the study information | 2011/02/01 |
| Last modified on | 2013/04/09 05:15:19 |
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Basic information
Public title
The efficacy and safety of Yokukansan for BPSD in Alzheimer's disease. a randomized, double-blind, placebo-control trial.
Acronym
The efficacy and safety of Yokukansan for BPSD in Alzheimer's disease.
Scientific Title
The efficacy and safety of Yokukansan for BPSD in Alzheimer's disease. a randomized, double-blind, placebo-control trial.
Scientific Title:Acronym
The efficacy and safety of Yokukansan for BPSD in Alzheimer's disease.
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Geriatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the superiority of Yokukansan over placebo on BPSD (Behavioral and Psychological Symptoms of Dementia) in Alzheimer's disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Neuropsychiatric Inventory-Q-J(NPI-Q-J)
Key secondary outcomes
Mini-Mental-State-Examination-J (MMSE-J)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TSUMURA Yokukansan Extract Granules
(active drug)
Interventions/Control_2
TSUMURA Yokukansan Extract Granules
(placebo)
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
| 55 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Patients with mild to moderate Alzheimer's disease.
2)BPSD is present on NPI-Q-J.
3)Serum potassium level should be in normal range.
4)have a study partner able to provide an
independent evaluation of functioning.
5) Agreement to sign an informed consent
Key exclusion criteria
1)Patients with non-Alzheimer's dementia
2)No lesion exists in brain MRI.
3)Presence of severe illness
4)Those who have used Yokukansan ever before
5)Those who have joined any clinical trial
within 3 month
6)Those who are thought inadequate by their doctor.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Arai |
Organization
Institute of Development, Aging and Cancer
Tohoku university
Division name
Department of Geriatrics and Gerontology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
81-22-717-7182
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Institute of Development, Aging and Cancer
Division name
Department of Geriatrics and Gerontology
Zip code
Address
4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
81-22-717-7182
Homepage URL
Sponsor or person
Institute
Institute of Development, Aging and Cancer
Tohoku university, Department of Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ministory of health, labour and welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
岩手医科大学病院（岩手県）
鳥取大学病院（鳥取県）
杏林大学病院（東京都）
慶應義塾大学病院(東京都)
群馬大学病院（群馬県）
山梨大学病院（山梨県）
大阪市立大学病院（大阪府）
けいめい記念病院（宮崎県）
東原整形外科病院（福岡県）
久里浜アルコール症センター（神奈川県）
仙台富沢病院（宮城県）
あおば脳神経外科（宮城県）
野村宏脳神経内科クリニック（宮城県）
など
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 02 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 05 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 27 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 27 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 27 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 10 | Month | 05 | Day |
Last modified on
| 2013 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005166
