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
Not Applicable
- Conditions
- idiopathic normal pressure hydrocephalus
- Registration Number
- JPRN-UMIN000035377
- Lead Sponsor
- The Japanese Society of NPH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 150
Inclusion Criteria
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method More than 1 level improvement on modified Rankin scale 24 months after randomization
- Secondary Outcome Measures
Name Time Method 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