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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000000466
Receipt No. R000000566
Scientific Title Japan Cooperative SPECT Study of Mild Impairment of Cognitive Function
Date of disclosure of the study information 2006/08/15
Last modified on 2014/12/03

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Basic information
Public title Japan Cooperative SPECT Study of Mild Impairment of Cognitive Function
Acronym J-COSMIC
Scientific Title Japan Cooperative SPECT Study of Mild Impairment of Cognitive Function
Scientific Title:Acronym J-COSMIC
Region
Japan

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

Objectives
Narrative objectives1 The goal of this study is to examine how SPECT 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

Not applicable
Gender Male and Female
Key inclusion criteria Amnestic MCI
Key exclusion criteria Significant neurological or psychiatric disease
Neurological abnormality
Psychiatric symptom
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiharu Yonekura
Organization National Institute of Radiological Sciences
Division name President
Zip code
Address 4-9-1,Anagawa,Inage-ku,Chiba-shi,
TEL 043-251-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masaru Tsuda
Organization Japan Foundation For Aging And Health
Division name Research Support Office
Zip code
Address 36-3, Gengo Morioka-cho, Obu-shi, Aichi, 474-8522, Japan
TEL 0562-45-5571
Homepage URL
Email j-cosmic@tyojyu.or.jp

Sponsor
Institute J-COSMIC Executive Committee
Institute
Department

Funding Source
Organization Japan Foundation For Aging And Health
Organization
Division
Category of Funding Organization Non profit foundation
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
2006 Year 08 Month 15 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
2003 Year 08 Month 08 Day
Date of IRB
Anticipated trial start date
2003 Year 10 Month 01 Day
Last follow-up date
2008 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2009 Year 07 Month 01 Day

Other
Other related information 1. Prospective registration of approximately 500 patients with MCI
2. All Patients undergo baseline brain perfusion SPECT and clinical/cognitive assessments.
3. All Patients will undergo clinical/cognitive assessments every year, and brain perfusion SPECT occasionally.
4. Patients with MCI will be followed for 3 years, or till the end point.
5. Calculation of the diagnostic ability of baseline SPECT to predict the conversion from MCI to AD after 3 years

Management information
Registered date
2006 Year 08 Month 10 Day
Last modified on
2014 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000566

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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