UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000466 |
|---|---|
| Receipt number | 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 16:49:55 |
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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
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
j-cosmic@tyojyu.or.jp
Sponsor or person
Institute
J-COSMIC Executive Committee
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
