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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN C000000297
Receipt No. R000000380
Scientific Title Study on Diagnosis of early Alzheimer's disease-Japan
Date of disclosure of the study information 2005/12/16
Last modified on 2016/08/15

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Basic information
Public title Study on Diagnosis of early Alzheimer's disease-Japan
Acronym SEAD-Japan
Scientific Title Study on Diagnosis of early Alzheimer's disease-Japan
Scientific Title:Acronym 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
1st name
Middle name
Last name Kengo Ito
Organization National Center for Geriatrics and Gerontology
Division name Department of Brain Science and Molecular Imaging, National Institute for Longevity Sciences
Zip code
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
1st name
Middle name
Last name Kengo Ito
Organization National Center for Geriatrics and Gerontology
Division name Department of Brain Science and Molecular Imaging, National Institute for Longevity Sciences
Zip code
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)

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
2005 Year 12 Month 16 Day

Related information
URL releasing protocol
Publication of results Published

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 Main results already published
Date of protocol fixation
2005 Year 11 Month 18 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000000380

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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