UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036210 |
|---|---|
| Receipt number | 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 09:13:58 |
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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
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
tiken2@shonan-atsugi.jp
Sponsor or person
Institute
Shonan Atsugi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041240
