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


Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name