UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002704 |
|---|---|
| Receipt number | R000003296 |
| Scientific Title | Pharmacotherapy for behavioral symptoms of frontotemporal dementia |
| Date of disclosure of the study information | 2009/11/04 |
| Last modified on | 2009/11/03 14:23:18 |
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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
frontotemporal dementia
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Behavioral symptoms of frontotemporal dementia (FTD) place a heavy burden on the caregivers. Although used to control symptoms, antipsychotic drugs have adverse effects that lower their ability to perform activities of daily living (ADL), and reduce their quality of life (QOL). Iwasaki et al. reported the effect of Yokukansan to behavioral and psychological symptoms of dementia (BPSD). Therefore, we evaluate the efficacy and safety of Yokukansan as a treatment of behavioral symptoms of 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
dose of 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 according 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, major 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
NHO Kikuchi Hospital
Division name
Division of Clinical Research
Zip code
Address
208 Fukuhara, Koshi, Kumamoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
NHO Kikuchi Hospital
Division name
Division of Clinical Research
Zip code
Address
TEL
Homepage URL
tkimura@kikuti.hosp.go.jp
Sponsor or person
Institute
NHO Kikuchi Hospital
Institute
Department
Personal name
Funding Source
Organization
NHO 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
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
| 2009 | Year | 11 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 11 | Month | 03 | Day |
Last modified on
| 2009 | Year | 11 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003296
