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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018369
Receipt No. R000021128
Scientific Title Exploratory study for the efficacy and safety of Yokukansankachimpihange on behavioral and psychological symptoms of dementia (BPSD) in patients with Alzheimer's disease (AD).
Date of disclosure of the study information 2015/08/01
Last modified on 2018/12/14

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Basic information
Public title Exploratory study for the efficacy and safety of Yokukansankachimpihange on behavioral and psychological symptoms of dementia (BPSD) in patients with Alzheimer's disease (AD).
Acronym The exploratory study of Yokukansankachimpihange on BPSD in patients with AD.
Scientific Title Exploratory study for the efficacy and safety of Yokukansankachimpihange on behavioral and psychological symptoms of dementia (BPSD) in patients with Alzheimer's disease (AD).
Scientific Title:Acronym The exploratory study of Yokukansankachimpihange on BPSD in patients with AD.
Region
Japan

Condition
Condition AD patients with BPSD
Classification by specialty
Neurology Psychiatry Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate exploratively the efficacy and safety of Yokukansankachimpihange on behavioral and psychological symptoms of Alzheimer's disease in a single-armed, open-label study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in neuropsychiatric inventory (NPI) total score before and after Yokukansankachimpihange treatment
Key secondary outcomes Changes in neuropsychiatric inventory (NPI) subscale score before and after Yokukansankachimpihange treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Yokukansankachimpihange treatment for 12 weeks
Interventions/Control_2
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
65 years-old <=
Age-upper limit
89 years-old >=
Gender Male and Female
Key inclusion criteria 1) probable AD
2) Within normal limit of serum potassium.
3) Have a study partner able to provide an independent evaluation of functioning.
4) Agreement to sign an informed consent.
Key exclusion criteria 1) Patients with neurological disease to affect the cognitive function except AD.
2) Patients who have local lesion which affected the cognitive function by CT or MRI.
3) Patients with serious diseases such as malignant tumors, or disorder which is not in stable condition.
4) Patient who has an allergy to Kampo medicine.
5) Patients considered inappropriate by the study investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaru Mimura
Organization Keio University School of Medicine
Division name Department of Neuropsychiatry
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160_8582, Japan
TEL 03-5363-3828
Email mimura@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryutaro Arita
Organization Keio University School of Medicine
Division name Center for Kampo Medicine
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160_8582, Japan
TEL 03-5366-3824
Homepage URL http://www.keio-kampo.jp/ja_2/page07.html
Email tarikun@a6.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization TSUMURA & CO.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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 慶應義塾大学医学部(東京都)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.scirp.org/Journal/PaperInformation.aspx?PaperID=89050
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
2015 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 04 Month 01 Day
Date trial data considered complete
2017 Year 04 Month 10 Day
Date analysis concluded
2017 Year 05 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 07 Month 21 Day
Last modified on
2018 Year 12 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021128

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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