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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036952
Receipt No. R000042101
Scientific Title A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients.
Date of disclosure of the study information 2019/06/04
Last modified on 2019/06/04

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Basic information
Public title A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients.
Acronym A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients.
Scientific Title A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients.
Scientific Title:Acronym A PET study with 18F-FDOPA and 11C-Raclopride on Parkinson's disease and related disorders patients.
Region
Japan

Condition
Condition Patients who are suspected Parkinson's disease or related disorders, including dementia with Lewy bodies, multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, frontotemporal lobe degeneration, vascular parkinsonism, drug-induced parkinsonism, normal pressure hydrocephalus, and others.
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To disclose the pathophysiological conditions in the dopaminergic system of Parkinson's disease and related disorders patients by using 18F-FDOPA and 11C-Raclopride PET.
Basic objectives2 Others
Basic objectives -Others pathophysiology
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of conditions of dopamine metabolism and D2 receptor function among disorders.
Key secondary outcomes Relationship between clinical pictures and conditions of dopamine metabolism or D2 receptor function.

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
Device,equipment
Interventions/Control_1 18F-FDOPA, 11C-Raclopride PET
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who have intention to participate in the PET study and are suspected having Parkinson's disease or related disorders.
Key exclusion criteria Patients having history of seizure, alcoholism, or any kind of drug dependency.
Patients recognized to be inappropriate by anyone of attending physicians or study staffs.
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Yoshihiko
Middle name
Last name Horimoto
Organization Nagoya City Rehabilitation Agency
Division name Department of Neurology
Zip code 4678622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Email holly@nagoya-rehab.or.jp

Public contact
Name of contact person
1st name Yoshihiko
Middle name
Last name Horimoto
Organization Nagoya City Rehabilitation Agency
Division name Department of Neurology
Zip code 4678622
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
TEL 052-835-3811
Homepage URL
Email holly@nagoya-rehab.or.jp

Sponsor
Institute Nagoya City Rehabilitation Agency
Institute
Department

Funding Source
Organization Nagoya City Rehabilitation Agency
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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

IRB Contact (For public release)
Organization Nagoya City Rehabilitation Agency
Address 1-2 Mikanyama, Yatomi-cho, Mizuho-ku, Nagoya, Japan
Tel 052-835-3811
Email soumubu@nagoya-rehab.or.jp

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 名古屋市総合リハビリテーション事業団(愛知県)

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 04 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 Enrolling by invitation
Date of protocol fixation
2019 Year 05 Month 20 Day
Date of IRB
2019 Year 05 Month 29 Day
Anticipated trial start date
2019 Year 06 Month 04 Day
Last follow-up date
2025 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 04 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042101

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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