UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on Diagnosis of early Alzheimer's disease-Japan
Title of the study (Brief title)	SEAD-Japan
Region	Japan

Condition
Condition	Mild Cognitive Impairment
Classification by specialty	Neurology Geriatrics Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The goal of this study is to examine how FDG-PET can be used with other tests to predict the conversion from MCI to Alzheimer's disease.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Alzheimer's disease
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	79 years-old >=
Gender	Male and Female
Key inclusion criteria	Amnestic MCI No significant neurologic or psychiatric disease No neurological abnormality No psychiatirc symptom (Geriatric Depression Scale <=10)
Key exclusion criteria	History of alcohol abuse or dependency History of epilepsy Years of schooling <=6 No study partner Diabetes mellitus under insulin treatment Specific psychoactive medications (for example, certain antidepressants, anti-anxiety medications, sleeping pills, etc.) Donepezil hydrochloride within the past one month before PET study Critical complication
Target sample size	150

Research contact person
Name of lead principal investigator	Kengo Ito
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Brain Science and Molecular Imaging, National Institute for Longevity Sciences
Address	36-3, Gengo Morioka-cho, Obu-shi, Aichi, 474-8522, Japan
TEL	0562-46-2311
Email	kito@ncgg.go.jp

Public contact
Name of contact person	Kengo Ito
Organization	National Center for Geriatrics and Gerontology
Division name	Department of Brain Science and Molecular Imaging, National Institute for Longevity Sciences
Address	36-3, Gengo Morioka-cho, Obu-shi, Aichi, 474-8522, Japan
TEL	0562-46-2311
Homepage URL
Email	kito@ncgg.go.jp

Sponsor
Institute	Department of Brain Science and Molecular Imaging National Institute for Longevity Sciences National Center for Geriatrics and Gerontology
Institute
Department

Funding Source
Organization	Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japan

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	2005 Year 12 Month 16 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2005 Year 11 Month 18 Day
Anticipated trial start date	2005 Year 12 Month 01 Day
Last follow-up date	2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	Prospective Cohort Study

Management information
Registered date	2005 Year 12 Month 16 Day
Last modified on	2016 Year 08 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000380