UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011612 |
|---|---|
| Receipt number | R000013584 |
| Scientific Title | Evaluation of Amyloid Imaging in People with Metabolic Disorder Identified by Brain FDG-PET as Part of a Complete Medical Checkup |
| Date of disclosure of the study information | 2013/10/01 |
| Last modified on | 2018/09/04 09:19:28 |
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Basic information
Public title
Evaluation of Amyloid Imaging in People with Metabolic Disorder Identified by Brain FDG-PET as Part of a Complete Medical Checkup
Acronym
Amyloid Imaging in Medical Checkup
Scientific Title
Evaluation of Amyloid Imaging in People with Metabolic Disorder Identified by Brain FDG-PET as Part of a Complete Medical Checkup
Scientific Title:Acronym
Amyloid Imaging in Medical Checkup
Region
| Japan |
Condition
Condition
Alzheimer disease
Classification by specialty
| Neurology | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this research is to establish evidence on the usefulness of amyloid PET and brain FDG-PET in the preclinical diagnosis of AD. People who have abnormal metabolism identified by FDG-PET will undergo amyloid PET, detailed cognitive function tests, symptom assessments and other examinations. Those who have abnormal metabolism on an FDG-PET scan and positive amyloid PET (stage 2 preclinical AD) and those who have abnormal metabolism on an FDG-PET scan and normal amyloid PET (which may represent non-preclinical AD but suggest other neurological disease) will be monitored for a long term to assess changes in clinical features and cognitive function over time.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Each 30 subjects who have abnormal metabolism on an FDG-PET scan and positive amyloid PET (stage 2 preclinical AD) and those who have abnormal metabolism on an FDG-PET scan and normal amyloid PET (which may represent non-preclinical AD but suggest other neurological disease) will be monitored for a long term to assess changes in clinical features and cognitive function over time.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The study population will consist of people who have a special cancer screening (whole-body FDG-PET) at the Preventive Medicine Center and consent to undergo cognitive function tests and brain FDG-PET.
Key exclusion criteria
Disagree
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koji Murakami |
Organization
School of medicine, Keio University
Division name
Department of radiology,
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-3353-1211
kjmuraka@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Ito |
Organization
School of medicine, Keio University
Division name
Department of neurology
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
+81-3-5363-3788
Homepage URL
d-ito@jk9.so-net.ne.jp
Sponsor or person
Institute
School of medicine, Keio University
Institute
Department
Personal name
Funding Source
Organization
Piramal
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 10 | Month | 01 | 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
Amyloid PET negaitve
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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 05 | Month | 01 | Day |
Other
Other related information
1.Amyloid PET (AV1)
2.Brain FDG-PET
3.Brief cognitive function tests (MMSE, CDT and MOCA)
4.Assessments of symptoms and insight (e.g., UPDRS, NPI and GDS)
5.Cognitive function assessments (RCPM,RAVLT,ROCFT,WMS-R,Trail Making Test,Stroop Test,Word fluency)
Management information
Registered date
| 2013 | Year | 08 | Month | 31 | Day |
Last modified on
| 2018 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013584
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
