UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018045 |
|---|---|
| Receipt number | R000020880 |
| Scientific Title | Research on Determining Normal Binding Extent of Dopamine Transporter Binding Ratio using 123I-FP-CIT SPECT |
| Date of disclosure of the study information | 2015/06/30 |
| Last modified on | 2017/06/26 10:33:19 |
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Basic information
Public title
Research on Determining Normal Binding Extent of Dopamine Transporter Binding Ratio using 123I-FP-CIT SPECT
Acronym
Normal Binding Extent of Dopamine Transporter Scintigraphy using 123I-FP-CIT SPECT
Scientific Title
Research on Determining Normal Binding Extent of Dopamine Transporter Binding Ratio using 123I-FP-CIT SPECT
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Yumiko Motoi |
Organization
Graduate School of Medicine, Juntendo University
Division name
Department of Neurology
Zip code
Address
Hongo Bunkyo-Ku 2-1-1 Tokyo
TEL
03-3813-3111
motoi@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yumiko Motoi |
Organization
Graduate School of Medicine, Juntendo University
Division name
Department of Neurology
Zip code
Address
Hongo Bunkyo-Ku 2-1-1 Tokyo
TEL
03-3813-3111
Homepage URL
motoi@juntendo.ac.jp
Sponsor or person
Institute
Department of Neurology,Juntendo University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/?term=motoi%2C+Dopamine%2C+Yamamoto
Number of participants that the trial has enrolled
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).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 30 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020880
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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