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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

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 - SINPHONI-3

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000035377
Enrollment
150
Registered
2019-04-01
Start date
2019-08-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

idiopathic normal pressure hydrocephalus

Interventions

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&#39
s disease pathology 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&#39
s disease in idiopathic normal pressure hydrocephalus with Alzheimer&#39
s disease pathology 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&#39
s disease pathology

Sponsors

The Japanese Society of NPH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
More than 1 level improvement on modified Rankin scale 24 months after randomization—

Secondary

MeasureTime frame
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—

Countries

Japan

Contacts

Public ContactEtsuro Mori

Osaka University United Graduate School of Child Development Department of Behavioral Neurology and Neuropsychiatry

dbnn@psy.med.osaka-u.ac.jp06-6879-3373

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026