UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Amyloid Imaging in People with Metabolic Disorder Identified by Brain FDG-PET as Part of a Complete Medical Checkup
Title of the study (Brief title)	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	Koji Murakami
Organization	School of medicine, Keio University
Division name	Department of radiology,
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	+81-3-3353-1211
Email	kjmuraka@z3.keio.jp

Public contact
Name of contact person	Daisuke Ito
Organization	School of medicine, Keio University
Division name	Department of neurology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 08 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Amyloid PET negaitve
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/icdr_e/ctr_view.cgi?recptno=R000013584