UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027312 |
|---|---|
| Receipt number | R000031278 |
| Scientific Title | The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies |
| Date of disclosure of the study information | 2017/05/12 |
| Last modified on | 2024/11/19 12:29:51 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies
Acronym
DLB-Z
Scientific Title
The efficacy of Zonisamide for BPSD in Dementia with Lewy bodies
Scientific Title:Acronym
DLB-Z
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
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Neuropsychiatric Inventory
Key secondary outcomes
Mini Mental State Examination
Cognitive Fluctuation Inventory
Unified parkinson's Disease Rating Scale part3
Rescue medicine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
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
90
Research contact person
Name of lead principal investigator
| 1st name | Yukihiko |
| Middle name | |
| Last name | Washimi |
Organization
National Center for Geriatrics and Gerontology
Division name
Deputy Director
Zip code
474-8511
Address
7-430, Morioka, Obu, Aichi 474-8511 Japan
TEL
0562-46-2311
washimi@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Mayumi |
| Middle name | |
| Last name | Maeda |
Organization
Clinical Research Network for Dementia
Division name
Innovation Center for Clinical Research
Zip code
474-8511
Address
7-430 , Morioka, Obu, Aichi 474-8511 Japan
TEL
0562-46-2311
Homepage URL
http://www.crnd.jp
crndinfo@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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Clinical Research Review Board
Address
65 Tsurumai-cho Showa-ku Nagoya Aichi,Japan, Aichi
Tel
052-744-2479
ethics@med.nagoya-u.ac.jp
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
国立研究開発法人国立長寿医療研究センター(愛知県）
弘前大学医学部附属病院（青森県）
東京医科大学病院 （東京都）
浜松医療センター （静岡県）
独立行政法人 国立病院機構 広島西医療センター（広島県）
川崎医科大学附属病院（岡山県）
片山内科クリニック（岡山県）
独立行政法人 国立病院機構 まつもと医療センター（長野県）
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
https://jrct.niph.go.jp/latest-detail/jRCTs041180125
Publication of results
Published
Result
URL related to results and publications
https://jrct.niph.go.jp/latest-detail/jRCTs041180125
Number of participants that the trial has enrolled
25
Results
The results of the present study showed no trend for improvement in the BPSD of DLB with zonisamide, which was seen in our exploratory study, based on the amount of change in NPI after 2 and 4 weeks, and zonisamide was not shown to be effective against the BPSD of DLB.
Results date posted
| 2024 | Year | 11 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There were no differences between the two groups in the background factors of age (years), height (cm), weight (kg), BMI (kg/m2), diastolic blood pressure (mmHg), systolic blood pressure (mmHg), disease duration (months), NPI, MMSE, Cognitive Fluctuation Inventory, score on part 3 of the UPDRS, presence/absence of complications, remarkable medical history, use of prohibited concomitant medications before the start of the trial, use of restricted concomitant medications, use of medications for complications, and type of examinations (outpatient, inpatient) for concomitant treatment other than the drug therapy.
The active drug group had 4 men (33.3%) and 8 women (66.7%), and the placebo group had 6 men (50.0%) and 6 women (50.0%).
Participant flow
In this study, 35 subjects gave informed consent, of whom 25 (13 zonisamide group, 12 placebo group)were enrolled in the study, and 1 patient(zonisamide group) was discontinued.
Adverse events
Of the 25 patients enrolled in the study, 15 adverse events occurred, 3 of which were causally related. In addition, one serious adverse event (hospitalization due to dehydration) occurred, but the causal relationship was judged to be "unlikely related".
Outcome measures
The score for the primary endpoint showed a somewhat improving trend in the placebo group at both 2 and 4 weeks, but there were no significant differences. No significant differences were seen between the zonisamide group and the placebo group in the four secondary endpoints.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 02 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 12 | Day |
Last modified on
| 2024 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031278
