UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory study for the efficacy and safety of Yokukansankachimpihange on behavioral and psychological symptoms of dementia (BPSD) in patients with Alzheimer's disease (AD).
Title of the study (Brief title)	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	Masaru Mimura
Organization	Keio University School of Medicine
Division name	Department of Neuropsychiatry
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160_8582, Japan
TEL	03-5363-3828
Email	mimura@a7.keio.jp

Public contact
Name of contact person	Ryutaro Arita
Organization	Keio University School of Medicine
Division name	Center for Kampo Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.scirp.org/Journal/PaperInformation.aspx?PaperID=89050
Results
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