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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038947
Receipt No. R000044411
Scientific Title The relationship between central glial activation and peripheral proinflammatory material of Alzheimer's disease mesured by PET-TSPO imaging
Date of disclosure of the study information 2020/01/06
Last modified on 2020/12/24

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Basic information
Public title The relationship between central glial activation and peripheral proinflammatory material of Alzheimer's disease mesured by PET-TSPO imaging
Acronym PET-TSPO imaging :central glial activation and peripheral proinflammatory material of Alzheimer's disease
Scientific Title The relationship between central glial activation and peripheral proinflammatory material of Alzheimer's disease mesured by PET-TSPO imaging
Scientific Title:Acronym PET-TSPO imaging :central glial activation and peripheral proinflammatory material of Alzheimer's disease
Region
Japan

Condition
Condition Dementia of Alzheimer's disease
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 By using PET imaging with [11C]DPA-713, we will measure the central glial activation in the patients with AD. We will investigate the relationship between central glial activation and the peripheral material related to the infllamation and glial acivation
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between the central glial activation measured by PET with [11C]DPA-713 and the peripheral material related to the infllamation and glial acivation
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
50 years-old <=
Age-upper limit
84 years-old >=
Gender Male and Female
Key inclusion criteria Alzheimer`s disase patient whose symptoms fulfilled the clinical diagnostic criteria
Key exclusion criteria The AD patients with medical history of
neurological and psychiatrical disease
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Fumihiko
Middle name
Last name Yasuno
Organization National Center for Geriatrics and Gerontology
Division name Department of Psychiatry
Zip code 474-8511
Address 7-430 Morioka-cho Obu, Aichi
TEL 0562-46-2311
Email yasunof@ncgg.go.jp

Public contact
Name of contact person
1st name Fumihiko
Middle name
Last name Yasuno
Organization National Center for Geriatrics and Gerontology
Division name Department of Psychiatry
Zip code 474-8511
Address 7-430 Morioka-cho Obu, Aichi
TEL 0562-46-2311
Homepage URL
Email yasunof@ncgg.go.jp

Sponsor
Institute National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization National Center for Geriatrics and Gerontology
Address 7-430 Morioka-cho
Tel 0562462311
Email yaday@ncgg.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
2020 Year 01 Month 06 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 01 Day
Date of IRB
2019 Year 09 Month 13 Day
Anticipated trial start date
2019 Year 11 Month 01 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 Now the research is progressing according to the research protocol.

Management information
Registered date
2019 Year 12 Month 21 Day
Last modified on
2020 Year 12 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044411

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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