UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A MRI study in cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL) at 7T
Title of the study (Brief title)	A MRI study in CADASIL at 7T
Region	Japan

Condition
Condition	CADASIL
Classification by specialty	Neurology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Aim of the study is to clarify the mechanism of desease develpment through in-vivo observation of the patient brain.
Basic objectives2	Others
Basic objectives -Others	Acquire 7T MRI dataset of brain images from patient and healthy control groups.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	NA
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	10 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	Registered in the CADASIL database
Key exclusion criteria	Those not suitable for MRI
Target sample size	20

Research contact person
Name of lead principal investigator	Toshihiko Aso
Organization	Kyoto University Graduate School of Medicine
Division name	Human Brain Research Center
Address	Shogoin-kawaharacho 54
TEL	0757513695
Email	toaso@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Toshihiko Aso
Organization	Kyoto University Graduate School of Medicine
Division name	Human Brain Research Center
Address	Shogoin-kawaharacho 54
TEL	0757513695
Homepage URL
Email	toaso@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	2016 Year 11 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 10 Month 01 Day
Anticipated trial start date	2016 Year 11 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	NA

Management information
Registered date	2016 Year 10 Month 26 Day
Last modified on	2017 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027844