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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010631
Receipt No. 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

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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
Email

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
Email crndadmi@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012430

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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