UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research on Determining Normal Binding Extent of Dopamine Transporter Binding Ratio using 123I-FP-CIT SPECT
Title of the study (Brief title)	Normal Binding Extent of Dopamine Transporter Scintigraphy using 123I-FP-CIT SPECT
Region	Japan

Condition
Condition	Normal healthy control
Classification by specialty	Neurology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To establish normal extent (50-79 years of age) on specific binding ratio (SBR) and asymmetry index (AI) using Dopamine transporter scintigraphy (123I -FP-CIT)
Basic objectives2	Others
Basic objectives -Others	To establish normal extent (50-79 years of age) on specific binding ratio (SBR) and asymmetry index (AI)
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To establish normal extent (50-79 years of age) on specific binding ratio (SBR) and asymmetry index (AI)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	To perform dopamine transporter scintigraphy using 123I -FP-CIT intravenous injection
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	50 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	1) Japanese male/female volunteers who are healthy 2) Ages between 50- 90 (as of the consent acquisition date) 3) Individuals judged to be able to undergo necessary examinations on the designated dates after receiving their consent 4) Individuals with the total score of UPDRS part III held within 3 months before and after the consent acquisition date being 0 for the subjects 60 years or younger,or less than 5 for the subjects 61 years or older 5) Individuals whose cranial MRI taken within 3 months before and after the consent acquisition date was normal. Brain atrophy appropriate for age or small lacunar infarction is acceptable. 6) Individuals who can submit a written letter of consent to join this study
Key exclusion criteria	1) Individuals who are pregnant, possibly pregnant, or lactating 2) Individuals with past history of alcoholism, or alcoholics currently under treatment 3) Individuals with past history of epilepsy, or epileptics currently under treatment 4) Individuals with less than 6-year education 5) Individuals who are prescribed with antidepressant or psychotropics, or sedatives including anti-anxiety agents for a long time 6) Individuals with past history of mental or neurological illnesses which affect cognitive functions 7) Individuals with serious complications such as hepatopathy, nephropathy, or endocrinopathy 8) Individuals taking the below mentioned drugs that are considered to affect on accumulation of 123I FP-CIT in the brain within a month after administering the same: cocaine hydrochloride, mazindol, methylphenidate hydrochloride, sertraline hydrochloride, and selective serotonin reuptake inhibitor 9) Individuals judged inappropriate for accomplishing our objective by the principal investigator, researchers in charge, or cooperative researchers
Target sample size	40

Research contact person
Name of lead principal investigator	Yumiko Motoi
Organization	Graduate School of Medicine, Juntendo University
Division name	Department of Neurology
Address	Hongo Bunkyo-Ku 2-1-1 Tokyo
TEL	03-3813-3111
Email	motoi@juntendo.ac.jp

Public contact
Name of contact person	Yumiko Motoi
Organization	Graduate School of Medicine, Juntendo University
Division name	Department of Neurology
Address	Hongo Bunkyo-Ku 2-1-1 Tokyo
TEL	03-3813-3111
Homepage URL
Email	motoi@juntendo.ac.jp

Sponsor
Institute	Department of Neurology,Juntendo University
Institute
Department

Funding Source
Organization	Nihon Medi-Physics
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	2015 Year 06 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 30 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date	2016 Year 06 Month 30 Day
Date of closure to data entry	2016 Year 08 Month 31 Day
Date trial data considered complete	2016 Year 08 Month 31 Day
Date analysis concluded	2016 Year 12 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/?term=motoi%2C+Dopamine%2C+Yamamoto
Results	A strong correlation between the SBR and age was observed. The correlation coefficient in males and females were -0.566 and -0.502, respectively. The analysis of variance revealed that aging led to a decline of the SBR, and a significant difference (p？=？0.005) was observed among generations. Gender also affected the SBR, and there was a significant difference between males and females (p？=？0.036). The SBR in females was higher than in males. Consequently, the multiple comparison revealed a significant difference between 50s and 70s (p？=？0.015) and 50s and 80s (p？=？0.006).
Other related information	Ann Nucl Med. 2017 Jun;31(5):407-412. doi: 10.1007/s12149-017-1168-1. Epub 2017 Apr 5. Age-related effects and gender differences in Japanese healthy controls for [123I] FP-CIT SPECT. Yamamoto H1, Arimura S1, Nakanishi A1, Shimo Y2, Motoi Y3,4, Ishiguro K2, Murakami K1, Hattori N5,2, Aoki S1.

Management information
Registered date	2015 Year 06 Month 23 Day
Last modified on	2017 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020880