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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035377
Receipt No. 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 2021/01/04

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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
Email 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
Email dbnn@psy.med.osaka-u.ac.jp

Sponsor
Institute The Japanese Society of NPH
Institute
Department

Funding Source
Organization The Japanese Society of NPH
Organization
Division
Category of Funding Organization Other
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
Email 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 Open public 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
2025 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
2021 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040263

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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