UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018369 |
|---|---|
| Receipt number | 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 15:37:45 |
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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
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
tarikun@a6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
