UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003608 |
|---|---|
| Receipt number | R000004374 |
| Scientific Title | Imaging study using positron emission tomography with AV-45 for dementia |
| Date of disclosure of the study information | 2010/05/12 |
| Last modified on | 2017/11/16 10:26:39 |
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Basic information
Public title
Imaging study using positron emission tomography with AV-45 for dementia
Acronym
Positron emission tomography for dementia
Scientific Title
Imaging study using positron emission tomography with AV-45 for dementia
Scientific Title:Acronym
Positron emission tomography for dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the distribution and deposits of beta-amyloid in brain using positron emission tomography and the correlation between the imaging data and cognitive function in Alzheimer's disease and mild cognitive impairment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amyloid deposits and distribution in brain measured by positron emission tomography among patients and age-matched normal controls.
Key secondary outcomes
To investigate the correlation between the cognitive function, brain MRI, and FDG-PET and amyloid deposits.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
PET, MRI, Neuropsychological test
Interventions/Control_2
PET, MRI, Neuropsychological test
Interventions/Control_3
PET, MRI, Neuropsychological test
Interventions/Control_4
PET, MRI, Neuropsychological test
Interventions/Control_5
PET, MRI, NEuropsychological test
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects who have the ability to provide informed consent and adhere to the protocol.
Normal controls:
- Without past or current history of cognitive dysfunction
- Mini-Mental State Exam score is 28 or more
Alzheimer's disease:
- Subject who meet the diagnostic criteria of Alzheimer's disease on International classification of Diseases 10th revision
- Informed consents are obtained from patients and one of their family members
Mild cognitive impairment:
- Memory complaints by subject that is verified by a study partner
- Objective cognitive impairment
- General cognition and functional performance sufficiently preserved
- Not meet the criteria of dementia
Mental disorder with cognitive impairment
Age-related macular degeneration
Key exclusion criteria
Exclusion criteria:
- With past or current history of serious medical illness and/or brain organic diseases
- Subject who is contraindicated for the use of MRI
- With past or current history of severe liver disease, kidney disease, heart disease, allergy, or severe drug allergy
- Subjects who are judged as not suitable for participation in this study
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiro Okubo, M.D., Ph.D. |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
03-3822-2131
okubo-y@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Amane Tateno, M.D., Ph.D. |
Organization
Nippon Medical School
Division name
Department of Neuropsychiatry
Zip code
Address
1-1-5 Sendagi, Bunkyo-ku, Tokyo 113-8603, Japan
TEL
03-3822-2131
Homepage URL
amtateno@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
日本医科大学付属病院健診医療センター、日本医科大学付属病院、メディカルサテライト八重洲クリニック神田分院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2010 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2017 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 05 | Month | 12 | Day |
Last modified on
| 2017 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004374
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