UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025638
Receipt number R000029497
Scientific Title Adenosine A2A receptors in Parkinson's disease
Date of disclosure of the study information 2017/01/16
Last modified on 2018/12/14 10:43:13

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Basic information

Public title

Adenosine A2A receptors in Parkinson's disease

Acronym

Adenosine A2A receptors in Parkinson's disease

Scientific Title

Adenosine A2A receptors in Parkinson's disease

Scientific Title:Acronym

Adenosine A2A receptors in Parkinson's disease

Region

Japan


Condition

Condition

Parkinson's disease

Classification by specialty

Neurology Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

investigate the relationship between Parkinson's disease and adenosine a2a receptor

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Measurement of adenosine a2a receptor availability in Parkinson's disease

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

Self control

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

11C-preladenant-PET scanning

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

40 years-old <=

Age-upper limit

89 years-old >=

Gender

Male and Female

Key inclusion criteria

1. The subjects who have intention to participate in this study, and signed informed consent.
2. Male and female subjects of >=40 and <90 years, old.
3. The subjects who were diagnosed with dementia

Key exclusion criteria

1. The subjects with a history of brain diseases, excluding than cerebellar diseases.
2. The subjects who are prescribed a medication for the central nervous system.
3. The subject who have chronic dysfunction in the organs.
4. Pregnant or woman who has a chance of pregnant.
5. The subjects who were judged by the clinical investigator to be inappropriate as a participant in this study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Ishibashi

Organization

Tokyo Metropolitan Institute of Gerontology

Division name

Research Team for Neuroimaging

Zip code


Address

35-2, Sakae-cho, Itabashi-ku, Tokyo

TEL

03-3964-3241

Email

ishibashi@pet.tmig.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kenji Ishibashi

Organization

Tokyo Metropolitan Institute of Gerontology

Division name

Research Team for Neuroimaging

Zip code


Address

35-2, Sakae-cho, Itabashi-ku, Tokyo

TEL

03-3964-3241

Homepage URL


Email

ishibashi@pet.tmig.or.jp


Sponsor or person

Institute

Tokyo Metropolitan Institute of Gerontology

Institute

Department

Personal name



Funding Source

Organization

Tokyo Metropolitan Institute of Gerontology

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2017 Year 01 Month 16 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

2016 Year 11 Month 01 Day

Date of IRB


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



Other

Other related information



Management information

Registered date

2017 Year 01 Month 12 Day

Last modified on

2018 Year 12 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029497


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name