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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004325
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Institute of Development, Aging and Cancer
Tohoku university, Department of Geriatrics and Gerontology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005166

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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