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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003241
Receipt No. R000003286
Scientific Title Pharmacotherapy for behavioral symptoms of frontotemporal dementia
Date of disclosure of the study information 2010/02/23
Last modified on 2010/02/23

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Basic information
Public title Pharmacotherapy for behavioral symptoms of frontotemporal dementia
Acronym Pharmacotherapy for frontotemporal dementia
Scientific Title Pharmacotherapy for behavioral symptoms of frontotemporal dementia
Scientific Title:Acronym Pharmacotherapy for frontotemporal dementia
Region
Japan

Condition
Condition Frototemporal dementia
Classification by specialty
Neurology Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Behavioral and psychological symptoms of dementia (BPSD) of frontotemporal dementia (FTD) place a heavy burden on the caregivers. We will evaluate the efficacy and safety of Yokukansan as a treatment for BPSD in FTD.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Neuropsychiatric Inventory (NPI)
Key secondary outcomes Stereotypy Rating Inventory (SRI)

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 7.5 g/day Yokukansan
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
50 years-old <=
Age-upper limit
90 years-old >=
Gender Male and Female
Key inclusion criteria FTD patients diagnosed accoding to Consensus guidelines of FTD (Neurology 1998; 51: 1546-1554)
Key exclusion criteria (1) delirium due to metabolic intoxication and drug use; (2) alcoholism, stroke, depression, manic state, and schizophrenia before the onset of FTD; (3) previous use of Yokukansan, tranquilizers, and antidepressants; (4) neoplastic disease and acute inflammation
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takemi Kimura
Organization National Hospital Organization Kikuchi Hospital
Division name Division of Clinical Research
Zip code
Address 208 Fukuhara, Koshi, Kumamoto
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Hospital Organization Kikuchi Hospital
Division name Division of Clinical Research
Zip code
Address
TEL
Homepage URL
Email tkimura@kikuti.hosp.go.jp

Sponsor
Institute National Hospital Organization Kikuchi Hospital
Institute
Department

Funding Source
Organization National Hospital Organization Kikuchi Hospital
Organization
Division
Category of Funding 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

Other administrative information
Date of disclosure of the study information
2010 Year 02 Month 23 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
2008 Year 04 Month 14 Day
Date of IRB
Anticipated trial start date
2008 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 02 Month 23 Day
Last modified on
2010 Year 02 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003286

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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