UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035377 |
|---|---|
| Receipt number | R000040263 |
| Scientific Title | Study of Idiopathic Normal Pressure Hydrocephalus on Neurological Improvement part 3 -Effectiveness and safety of shunt surgery for idiopathic normal pressure hydrocephalus patients with Alzheimer's disease pathology |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2024/01/10 09:20:43 |
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Basic information
Public title
Study of Idiopathic Normal Pressure Hydrocephalus on Neurological Improvement part 3 -Effectiveness and safety of shunt surgery for idiopathic normal pressure hydrocephalus patients with Alzheimer's disease pathology
Acronym
SINPHONI-3
Scientific Title
Study of Idiopathic Normal Pressure Hydrocephalus on Neurological Improvement part 3 -Effectiveness and safety of shunt surgery for idiopathic normal pressure hydrocephalus patients with Alzheimer's disease pathology
Scientific Title:Acronym
SINPHONI-3
Region
| Japan |
Condition
Condition
idiopathic normal pressure hydrocephalus
Classification by specialty
| Neurology | Psychiatry | Radiology |
| Neurosurgery | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy and safety of shunt surgery for idiopathic normal pressure hydrocephalus patients with Alzheimer's disease pathology in a randomized controlled trial
Basic objectives2
Others
Basic objectives -Others
To assess long-term benefits of shunt surgery for idiopathic normal pressure hydrocephalus
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
More than 1 level improvement on modified Rankin scale 24 months after randomization
Key secondary outcomes
1)More than 1 level improvement on modified Rankin scale 12 months after randomization
2)Improvement of gait, cognitive, and urinary dysfunction every 3 months after randomization
3)Longitudinal changes of the value of CSF biomarker
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
To assess an incidence of one point or more improvement on modified Rankin scale at 24 months after randomization in idiopathic normal pressure hydrocephalus with Alzheimer's disease pathology
Interventions/Control_2
To assess an incidence of one point or more improvement on modified Rankin scale at 24 months after randomization with rehabilitation or standard treatment for Alzheimer's disease in idiopathic normal pressure hydrocephalus with Alzheimer's disease pathology
Interventions/Control_3
To assess an incidence of one point or more improvement on modified Rankin scale at 24 months after allocation in idiopathic normal pressure hydrocephalus without Alzheimer's disease pathology
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
| 60 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 60 - 84 years old
2)gait disturbance caused by idiopathic normal pressure hydrocephalus
3)ventriculomegaly (Evans index > 0.3)
4)high convexity tightness in coronal MRI
5)idiopathic
Key exclusion criteria
1) unpromising improvement due to motor, visceral or psychiatric disorders
2)association with malignancy or difficulty in one-year follow-up
3)hemorrhagic diathesis, coagulopathy or hemorrhagic disorders(intracerebral hemorrhage, subarachnoid hemorrhage)
4)hepatic failure
5)renal failure requiring artificial dialysis
6)planned major surgery during the study period
7)on medication with anticoagulant or antiplatelet agents without interruption
8)unsuitable by the decision of doctors
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Mori |
Organization
Osaka University United Graduate School of Child Development
Division name
Department of Behavioral Neurology and Neuropsychiatry
Zip code
565-0871
Address
2-2, Yamadaoka, Suita Osaka
TEL
06-6879-3373
dbnn@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Etsuro |
| Middle name | |
| Last name | Mori |
Organization
Osaka University United Graduate School of Child Development
Division name
Department of Behavioral Neurology and Neuropsychiatry
Zip code
565-0871
Address
2-2, Yamadaoka, Suita Osaka
TEL
06-6879-3373
Homepage URL
dbnn@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
The Japanese Society of NPH
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2, Yamadaoka, Suita Osaka
Tel
06-6210-8296
rinri@hp-crc.med.osaka-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
Other administrative information
Date of disclosure of the study information
| 2019 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | 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
| 2018 | Year | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040263
| 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 |
