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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004907
Receipt No. R000005843
Scientific Title Imaging study using positron emission tomography for the effect of nootropics on the athletic performance
Date of disclosure of the study information 2011/01/20
Last modified on 2013/07/20

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Basic information
Public title Imaging study using positron emission tomography for the effect of nootropics on the athletic performance
Acronym PET imaging for the effect of the nootropics
Scientific Title Imaging study using positron emission tomography for the effect of nootropics on the athletic performance
Scientific Title:Acronym PET imaging for the effect of the nootropics
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of nootropics on the monoaminergic neuron system using positron emission tomography. To evaluate the association between imaging data and blood and/or urine concentration.
Basic objectives2 PK,PD
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect of the nootropics on the monoaminergic neuron system quantified by positron emission tomography
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 PET,MRI, blood concentration, urine concentration
Interventions/Control_2 PET,MRI, blood concentration, urine concentration
Interventions/Control_3 PET,MRI, blood concentration, urine concentration
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Subjects who have the ability to provide informed consent and adhere to the protocol.
Key exclusion criteria Exclusion criteria:
- with past or current history of psychiatric illness
- with past or current history of serious medical illness and/or brain organic diseases
- subject who is contraindicated for the use of MRI
- with past or current history ofsevere liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- subject who are judged as not suitable for participation in this study
Target sample size 15

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiro Okubo, M.D., Ph.D.
Organization Nippon Medical School
Division name Department of Neuropsychiatry
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Amane Tateno, M.D., Ph.D.
Organization Nippon Medical School
Division name Department of Neuropsychiatry
Zip code
Address 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
Homepage URL
Email

Sponsor
Institute Nippon Medical School
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 日本医科大学付属病院健診医療センター、日本医科大学付属病院、メディカルサテライト八重洲クリニック

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 20 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
2010 Year 12 Month 06 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
2011 Year 12 Month 01 Day
Date of closure to data entry
2012 Year 01 Month 01 Day
Date trial data considered complete
2012 Year 02 Month 01 Day
Date analysis concluded
2012 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2011 Year 01 Month 20 Day
Last modified on
2013 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005843

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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