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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036210
Receipt No. R000041240
Scientific Title Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Date of disclosure of the study information 2019/04/18
Last modified on 2019/04/18

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Basic information
Public title Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Acronym Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Scientific Title Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Scientific Title:Acronym Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Neurology Psychiatry Radiology
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim is to evaluate preclinical AD and MCI due to AD using PET amyloid imaging as a beta amyloid biomarker,and to clarify the progression of pre-symptomatic stage to AD dementia.
Basic objectives2 Others
Basic objectives -Others Understanding of the pathology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1)To investigate the deposits of beta-amyloid in brain cortex.
2)Degree of impairment of cognitive function correlate with beta-amyloid.
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 Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Three-dimensional Dynamic PET images of the brain will be acquired for 60min after intravenous administration of [11C-PIB](about 550 mBq ).
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
90 years-old >=
Gender Male and Female
Key inclusion criteria Written informed consent was obtained from patient or his/her family.
Key exclusion criteria The past or present history of psychiatric, disorders, cerebrovascular disease, degenerative disease of the brain and head injury.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Shizuo
Middle name
Last name Hatashita
Organization Shonan Atsugi Hospital
Division name Neurosurgery
Zip code 243-8551
Address Nukumizu118-1 Atsugi-City, Kanagawa, Japan
TEL 046-223-3636
Email tiken2@shonan-atsugi.jp

Public contact
Name of contact person
1st name Shizuo
Middle name
Last name Hatashita
Organization Shonan Atsugi Hospital
Division name Neurosurgery
Zip code 243-8551
Address Nukumizu118-1 Atsugi-City, Kanagawa, Japan
TEL 046-223-3636
Homepage URL
Email tiken2@shonan-atsugi.jp

Sponsor
Institute Shonan Atsugi Hospital
Institute
Department

Funding Source
Organization None
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 Tokushukai Group Ethical Comittee
Address 1-8-7, Koji-machi, Chiyoda-ku, Tokyo
Tel 03-3263-4801
Email mirai-ec1@mirai-iryo.com

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 04 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 03 Month 14 Day
Date of IRB
2019 Year 04 Month 15 Day
Anticipated trial start date
2019 Year 04 Month 18 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 03 Month 15 Day
Last modified on
2019 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041240

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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