UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000297 |
|---|---|
| Receipt number | 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 18:43:42 |
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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
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
kito@ncgg.go.jp
Sponsor or person
Institute
Department of Brain Science and Molecular Imaging
National Institute for Longevity Sciences
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000380
