UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of the differential diagnoses and co-morbidity between idiopathic normal pressure hydrocephalus and neurodegenerative diseases, using multimodal neuroimagings and CSF/blood/urine biomarkers
Title of the study (Brief title)	Study of the differential diagnoses and co-morbidity between idiopathic normal pressure hydrocephalus and neurodegenerative diseases
Region	Japan

Condition
Condition	idiopathic normal pressure hydrocephalus (iNPH)
Classification by specialty	Neurology Radiology Neurosurgery
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To find factors which worsen clinical courses of iNPH
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Establishment of a new therapeutic strategy for iNPH
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Satisfy the diagnostic criteria of possible iNPH according to the Japanese guideline
Key exclusion criteria	The physician in charge decided that the patient is inappropriate to participate to the study
Target sample size	100

Research contact person
Name of lead principal investigator	Masahiko Bundo
Organization	National center for geriatrics and gerontology
Division name	Department of Clinical and Experimental Neuroimaging
Address	7-430 Morioka-cho Obu, Aichi
TEL	0562-46-2311
Email	ibundou@ncgg.go.jp

Public contact
Name of contact person	Masahiko Bundo
Organization	National center for geriatrics and gerontology
Division name	Department of Clinical and Experimental Neuroimaging
Address	7-430 Morioka-cho Obu Aichi
TEL	0562-46-2311
Homepage URL
Email	ibundou@ncgg.go.jp

Sponsor
Institute	National center for geriatrics and gerontology
Institute
Department

Funding Source
Organization	National center for geriatrics and gerontology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 07 Month 23 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 07 Month 31 Day
Anticipated trial start date	2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Observation of unfavorable influence of biomarkers, which indicate neurodegenerative deseases, on the clincal outcomes of idiopathic normal pressure hydrocephalus.

Management information
Registered date	2015 Year 07 Month 22 Day
Last modified on	2018 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021291