UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001832 |
|---|---|
| Receipt number | 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 20:15:08 |
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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
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
kozaki-tky@umin.ac.jp
Sponsor or person
Institute
Department of Geriatric Medicine, Kyorin University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002208
