UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037410
Receipt No. R000042587
Scientific Title Synaptic density and tau deposition in dementia
Date of disclosure of the study information 2019/07/18
Last modified on 2020/01/17

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Pathophysiology of dementia on synaptic density and tau deposition in the brain
Acronym Pathophysiology of dementia on synaptic density and tau deposition in the brain
Scientific Title Synaptic density and tau deposition in dementia
Scientific Title:Acronym Synaptic density and tau deposition in dementia
Region
Japan

Condition
Condition The purpose of this study is to evaluate levels of different tau proteins using [18F]PM-PBB3 and [11C]PBB3 along with changes in synaptic density in patients with dementia and healthy subjects.
Classification by specialty
Neurology Psychiatry Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate levels of different tau proteins using [18F]PM-PBB3 and [11C]PBB3 along with changes in synaptic density in patients with dementia and healthy subjects.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Difference in [18F]PM-PBB3 binding, and [11C]PBB3 binding. Changes in [11C]UCB-J
Key secondary outcomes Correlations between [11C]UCB-J and tau deposition

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
Other
Interventions/Control_1 Intravenous injection of PET tracers
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
85 years-old >
Gender Male and Female
Key inclusion criteria Healthy participants aged 20 to 85 years or below
1.Individuals who have no history of psychiatric disease
2.Individuals who are consent to participate in this study
Patients
Met with criteria for AD, DLB and FTLD
Key exclusion criteria 1.Individuals who are nursing, pregnant and have a chance of pregnancy.
2.Individuals who have claustrophobia.
3.Individuals with illness that affects the study
4.Individuals who are assessed unsuitable for participants by doctors in charge.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yasuomi
Middle name
Last name Ouchi
Organization Hamamatsu University School of Medicine
Division name Department of Biofunctional Imaging
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL 053-435-2466
Email ouchi@hama-med.ac.jp

Public contact
Name of contact person
1st name Yasuomi
Middle name
Last name Ouchi
Organization Hamamatsu University School of Medicine
Division name Department of Biofunctional Imaging
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL 053-435-2466
Homepage URL
Email ouchi@hama-med.ac.jp

Sponsor
Institute Department of Biofunctional Imaging, Hamamatsu University School of Medicine
Institute
Department

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

Other related organizations
Co-sponsor Hamamatsu Medical Photonics Foundation
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hamamatsu University School of Medicine, Study Support Division
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel 053-435-2680
Email rinri@hama-med.ac.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 07 Month 18 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 Open public recruiting
Date of protocol fixation
2019 Year 07 Month 18 Day
Date of IRB
2018 Year 10 Month 05 Day
Anticipated trial start date
2019 Year 07 Month 19 Day
Last follow-up date
2023 Year 07 Month 19 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 07 Month 18 Day
Last modified on
2020 Year 01 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042587

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.