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Recruitment status
Unique ID issued by UMIN UMIN000001832
Receipt No. R000002208
Scientific Title Evaluation of efficacy of yokukansan in patients with dementia with Lewy bodies using NPI-D as an indicator.
Date of disclosure of the study information 2009/04/01
Last modified on 2009/04/01

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Basic information
Public title Evaluation of efficacy of yokukansan in patients with dementia with Lewy bodies using NPI-D as an indicator.
Acronym Examination of efficacy of yokukansan in patients with dementia with Lewy bodies
Scientific Title Evaluation of efficacy of yokukansan in patients with dementia with Lewy bodies using NPI-D as an indicator.
Scientific Title:Acronym Examination of efficacy of yokukansan in patients with dementia with Lewy bodies
Region
Japan

Condition
Condition Dementia with Lewy bodies
Classification by specialty
Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Exploratory examination of efficacy and safety of yokukansan in patients with dementia with Lewy bodies
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes NPI-D (administered at weeks 8 after the start of treatment)
Key secondary outcomes MMSE, Barthel Index, cerebral blood flow (administered at week 8 after the start of 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 Normal adult dosage is 7.5 g/day divided into 2 to 3 oral doses, and taken before or between meals. Dosage may be adjusted according to the patient's age, weight and symptoms. Administration period: 8 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
40 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria 1) Probable DLB patients diagnosed according to the international consensus criteria for DLB. 2) Patients with 4 or more points at least one subscale of NPI at the start of treatment 3) Patients with serum potassium levels within the standard range of the facility when measured within 6 weeks before the start of treatment 4) Patients must have the same caregiver who can transport the patient to the hospital for consultation during the study. 5) Outpatients must have a reliable caregiver at home during the entire duration of the study who can transport the patient to the hospital for consultation 6) Inpatients must have been receiving care at their respective medical facility for least 2 weeks before the start of study
Key exclusion criteria 1) Patients with malignancy, severe disease of heart, liver, renal, blood, lung and other life-threatening diseases 2) Patients who fail to meet the DSM-IV diagnostic criteria for our study, but show symptoms of BPSD due to other concomitant neurodegenerative disease, schizophrenia, bipolar disorder, major depression or other psychiatric disorders 3) Patients with delirium due to alcohol or drug addictions, metabolic poisoning, or inflammatory disease 4) Patients who are unable to take oral medications 5) Patients initiated the therapy with donepezil hydrochloride or made change in dosage and administration of the drug within 8 weeks before the start of treatment 6) Patients received drugs prohibited for concomitant use or drugs restricted in concomitant use during wash-out period, 7) Patients who took long acting antipsychotic drugs (such as haloperidol decanoate) within 4 weeks before the start of treatment 8) Patients who are determined as unfit for the study by attending physicians for reasons other than those stated above
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenji Toba
Organization Kyorin University
Division name Department of Geriatric Medicine, Kyorin University School of Medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611 JAPAN
TEL 0422-47-5511
Email

Public contact
Name of contact person
1st name
Middle name
Last name Koichi Kozaki
Organization Kyorin University
Division name Department of Geriatric Medicine, Kyorin University School of Medicine
Zip code
Address 6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611 JAPAN
TEL 0422-44-1917
Homepage URL
Email kozaki-tky@umin.ac.jp

Sponsor
Institute Department of Geriatric Medicine, Kyorin University School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 04 Month 01 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
Date of protocol fixation
2008 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 01 Day
Last follow-up date
2010 Year 12 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 03 Month 31 Day
Last modified on
2009 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002208

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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