UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pathophysiological analysis of Parkinson disease using DAT scan and MRI
Title of the study (Brief title)	Neuroimaging analysis of Parkinson disease
Region	Japan

Condition
Condition	Parkinson disease
Classification by specialty	Neurology Radiology Neurosurgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To know the role of dopamine in vivo
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To examine lesions of decrease of dopamine
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	30 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	healthy control Patients with Parkinson disease
Key exclusion criteria	1. communication disorder 2. serious condition of vital sign 3. no consent 4. cardiac pacemaker 5. implanted metallic or electrical devices 6. taking medicine which affects the uptake of [123I]-Ioflupane
Target sample size	20

Research contact person
Name of lead principal investigator	Ryosuke Takahashi
Organization	Kyoto University Graduated School of Medicine
Division name	Department of Neurology
Address	Kawara-machi 54, Shogo-in, Sakyo-ku, Kyoto, Japan
TEL	075-751-3771
Email	sawa@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	Nobukatsu Sawamoto
Organization	Kyoto University Graduated School of Medicine
Division name	Department of Neurology
Address	Kawara-machi 54, Shogo-in, Sakyo-ku, Kyoto, Japan
TEL	075-751-3771
Homepage URL
Email	sawa@kuhp.kyoto-u.ac.jp

Sponsor
Institute	Department of Neurology, Kyoto University Graduated School of Medicine
Institute
Department

Funding Source
Organization	Neurotransmission and research of brain function
Organization
Division
Category of Funding Organization	Profit 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	2014 Year 01 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 01 Month 22 Day
Anticipated trial start date	2014 Year 01 Month 22 Day
Last follow-up date	2016 Year 02 Month 01 Day
Date of closure to data entry	2016 Year 02 Month 01 Day
Date trial data considered complete	2016 Year 02 Month 01 Day
Date analysis concluded	2016 Year 02 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Prospective study

Management information
Registered date	2014 Year 01 Month 28 Day
Last modified on	2016 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015032