UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010631 |
|---|---|
| Receipt number | R000012430 |
| Scientific Title | The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies. A randomized, single-blind, placebo-control trial. |
| Date of disclosure of the study information | 2013/05/01 |
| Last modified on | 2016/08/05 14:20:23 |
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Basic information
Public title
The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies. A randomized, single-blind, placebo-control trial.
Acronym
The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies.
Scientific Title
The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies. A randomized, single-blind, placebo-control trial.
Scientific Title:Acronym
The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies.
Region
| Japan |
Condition
Condition
Dementia with Lewy bodies
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the superiority of Zonisamide over placebo on BPSD(Behavioral and Psychological Symptoms of Dementia)in patient with DLB(Dementia with Lewy bodies)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Neuropsychiatric Inventory
Key secondary outcomes
Mini Mental State Examination
Neuropsychiatric Inventory Brief Questionnare Form
Unified Parkinsons Disease Rating Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Excegran (Zonisamide)powdered+lactose
Interventions/Control_2
lactose
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
| 55 | years-old | <= |
Age-upper limit
| 84 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Probable DLB with the criteria of DLB workshop 2005
2 BPSD is present on NPI
3 MMSE score 10 26
4 WBC platelet Serum AST ALT ALP GTP level should be in normal range
5 Have a study partner able to provide an independent evaluation of functioning
6 Agreement to sign an informed consent
Key exclusion criteria
1 Patient with non DLB.
2 No focal lesion exists in brain MRI.
3 Has current serious illness, psychiatric problem or drug abuse.
4 Those who have used Zonisamide over before.
5 Those who have joined any clinical trial within 3 month.
6 Those who have received medications that affected the central nervous system within 4 weeks.
7 Dose of chronic medications that affect CNS should be stable for at least 4 weeks before Visit0.
8 Those who are judged inadequate by their doctor.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukihiko Washimi |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Cognitive Disorders
Zip code
Address
35 Gengo, Morioka, Obu, Aichi 474-8511 Japan
TEL
0562-46-2311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mayumi Maeda |
Organization
Clinical Research Network for Dementia
Division name
Department of Cognitive Disorders
Zip code
Address
35 Gengo, Morioka, Obu, Aichi 474-8511 Japan
TEL
0562462311
Homepage URL
http://www.crnd.jp
crndadmi@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
National Center for Geriatrics and Gerontology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
独立行政法人 国立長寿医療研究センター
National Center for Geriatrics and Gerontology
弘前大学医学部附属病院
Hirosaki University School of Medicine and Hospital
東京医科大学病院
Tokyo Medical University Hospital
浜松医科大学/浜松医療センター
Hamamatsu University School of Medicine/ Hamamatsu Medical Center
独立行政法人 国立病院機構 広島西医療センター
Hiroshima-Nishi Medical Center
川崎医科大学
Kawasaki Medical School and Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2012 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 01 | Day |
Last modified on
| 2016 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012430
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
