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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038620
Receipt No. R000044017
Scientific Title A study of the contributions of neurotransmitter systems and abnormal protein pathologies in the brain to the symptoms of FTLD-ALS spectrum patients
Date of disclosure of the study information 2019/12/01
Last modified on 2019/12/04

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Basic information
Public title A study of the contributions of neurotransmitter systems and abnormal protein pathologies in the brain to the symptoms of FTLD-ALS spectrum patients
Acronym A study of the contributions of neurotransmitter systems and abnormal protein pathologies in the brain to the symptoms of FTLD-ALS spectrum patients
Scientific Title A study of the contributions of neurotransmitter systems and abnormal protein pathologies in the brain to the symptoms of FTLD-ALS spectrum patients
Scientific Title:Acronym A study of the contributions of neurotransmitter systems and abnormal protein pathologies in the brain to the symptoms of FTLD-ALS spectrum patients
Region
Japan

Condition
Condition FTLD-ALS spectrum
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aims to quantify the density of metabotropic glutamate subtype 5 receptor and accumulated amyloid-beta and tau proteins, and to assess the association among neurotransmission, brain abnormally accumulated proteins, and clinical features in FTLS-ALS spectrum patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The associations between neurotransmitter systems evaluated by PET with (E)-[11C]ABP688 and MRI/MRS, and clinical symptoms.
Key secondary outcomes The associations between neurotransmitter systems evaluated by PET with (E)-[11C]ABP688 and MRI/MRS, and abnormally aggregated protein measured by PET with [18F]PM-PBB3 and [11C]PiB.

Base
Study type Interventional

Study design
Basic design Parallel
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 2
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 PET/MRI/psychological batteries/neurological examinations
Interventions/Control_2 PET/MRI/psychological batteries/neurological examinations
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 1) FTLD-ALS spectrum patients
1. 20 years of age or older at the time of obtaining consent
2. Subjects who can be accompanied by a legal guardian on the day of study participation
3. Subjects met with clinical diagnostic criteria of ALS or FTLD

2) Healthy volunteers
1. 20 years of age or older at the time of obtaining consent
2. Subjects with ability to make informed consent
Key exclusion criteria 1) FTLD-ALS spectrum patients
1. Subjects with organic brain complications/disorders
2. Subjects with substance-related disorders
3. Subjects with severe physical complications/disorders or a history of such conditions
4. Subjects with claustrophobia
5. Pregnant, possibly pregnant or lactating women
6. From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study (at National Institutes for Quantum and Radiological Science and Technology)
7. Subjects with metallic medical device in the body (at Nagoya university)
8. Subjects with tattoo (at Nagoya university)
9. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study

2) Healthy volunteers
1. Subjects with organic brain complications/disorders
2. Subjects with substance-related disorders
3. Subjects with severe physical complications/disorders or a history of such conditions
4. Subjects with metallic medical device in the body
5. Subjects with tattoo
6. Subjects with claustrophobia
7. Pregnant, possibly pregnant or lactating women
8. From the standpoint of radiation exposure from a nuclear medicine scan, subjects who have participated in other nuclear medicine scans as healthy volunteers in the 6 months prior to the start of this study (at National Institutes for Quantum and Radiological Science and Technology)
9. Subjects who are considered to be inappropriate for participation by doctors with responsibilities in this study
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Shimad
Organization National Institutes for Quantum and Radiological Science and Technology
Division name Department of Functional Brain Imaging Research, National Institute of Radiological Sciences
Zip code 263-0024
Address 4-9-1 Anagawa, Inage-ku, Chiba
TEL +81-43-206-3251
Email shimada.hitoshi@qst.go.jp

Public contact
Name of contact person
1st name Kazuko
Middle name
Last name Suzuki
Organization National Institutes for Quantum and Radiological Science and Technology
Division name Clinical Research Support Section, National Institute of Radiological Sciences
Zip code 263-0024
Address 4-9-1 Anagawa, Inage-ku, Chiba
TEL +81-43-206-3251
Homepage URL
Email suzuki.kazuko@qst.go.jp

Sponsor
Institute National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences, National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Center for Brain and Mind Research Promotion, Nagoya University Graduate School of Medicine
Name of secondary funder(s) Japan Agency for Medical Research and Development

IRB Contact (For public release)
Organization Certified Review Board
Address 4-9-1 Anagawa, Inage-ku, Chiba
Tel +81-43-206-4709
Email helsinki@qst.go.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

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 10 Month 26 Day
Date of IRB
2019 Year 10 Month 25 Day
Anticipated trial start date
2019 Year 12 Month 09 Day
Last follow-up date
2022 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 11 Month 19 Day
Last modified on
2019 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044017

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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