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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028758
Receipt No. R000032446
Scientific Title Amyloid PET imaging study for dimenting disorders
Date of disclosure of the study information 2017/09/19
Last modified on 2017/08/21

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Basic information
Public title Amyloid PET imaging study for dimenting disorders
Acronym Amyloid PET imaging study for dimenting disorders
Scientific Title Amyloid PET imaging study for dimenting disorders
Scientific Title:Acronym Amyloid PET imaging study for dimenting disorders
Region
Japan

Condition
Condition dementing disorder
Classification by specialty
Neurology Geriatrics Psychiatry
Neurosurgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of amyloid deposite in the patients with dementia, by using florbetapir(18F)
Basic objectives2 Others
Basic objectives -Others Evaluation of usefulness/safety for florbetapir(18F)
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of amyloid deposite in the patients with dementia (positive or negative)
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Evaluation of amyloid deposit by PET scan with florbetapir(18F)
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 atypical dementia patients
Key exclusion criteria delirium, depression,paranoia, drug-induced dementia state
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Abe
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama
Division name Department of Neurology
Zip code
Address 2-5-1 Shikatacho, Okayama 700-8558, Japan
TEL 086-235-7365
Email tooy@d1.dion.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toru Yamashita
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama
Division name Department of Neurology
Zip code
Address 2-5-1 Shikatacho, Okayama 700-8558, Japan
TEL 086-235-7365
Homepage URL
Email toruyamashita@okayama-u.ac.jp

Sponsor
Institute Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama
Institute
Department

Funding Source
Organization Eli Lilly and Company
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 09 Month 19 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
2017 Year 08 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 19 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 21 Day
Last modified on
2017 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032446

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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