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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011612
Receipt No. 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

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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
Email 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
Email d-ito@jk9.so-net.ne.jp

Sponsor
Institute School of medicine, Keio University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013584

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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