UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028758 |
|---|---|
| Receipt number | R000032446 |
| Scientific Title | Amyloid PET imaging study for dimenting disorders |
| Date of disclosure of the study information | 2017/09/19 |
| Last modified on | 2021/01/06 18:09:36 |
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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 | Koji |
| Middle name | |
| Last name | Abe |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama
Division name
Department of Neurology
Zip code
700-8558
Address
2-5-1 Shikatacho, Okayama 700-8558, Japan
TEL
086-235-7365
tooy@d1.dion.ne.jp
Public contact
Name of contact person
| 1st name | Toru |
| Middle name | |
| Last name | Yamashita |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama
Division name
Department of Neurology
Zip code
700-8558
Address
2-5-1 Shikatacho, Okayama 700-8558, Japan
TEL
086-235-7365
Homepage URL
toruyamashita@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama
Institute
Department
Personal name
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikatacho, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.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
| 2017 | Year | 09 | Month | 19 | Day |
Related information
URL releasing protocol
unpublished
Publication of results
Unpublished
Result
URL related to results and publications
unpublished
Number of participants that the trial has enrolled
20
Results
unpublished
Results date posted
| 2021 | Year | 01 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
unpublished
Participant flow
unpublished
Adverse events
unpublished
Outcome measures
unpublished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 08 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 25 | Day |
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
| 2021 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032446
