UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008674 |
|---|---|
| Receipt number | R000010194 |
| Scientific Title | Exploratory study on efficacy and safety of [11C]ketoprofen methylester in mild Alzheimer's disease, mild cognitive impairment and healthy volunteers. |
| Date of disclosure of the study information | 2012/08/13 |
| Last modified on | 2013/08/11 09:49:28 |
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Basic information
Public title
Exploratory study on efficacy and safety of [11C]ketoprofen methylester in mild Alzheimer's disease, mild cognitive impairment and healthy volunteers.
Acronym
KET-2
Scientific Title
Exploratory study on efficacy and safety of [11C]ketoprofen methylester in mild Alzheimer's disease, mild cognitive impairment and healthy volunteers.
Scientific Title:Acronym
KET-2
Region
| Japan |
Condition
Condition
Alzheimer's disease
Mild cognitive impairment
Classification by specialty
| Neurology | Geriatrics | Psychiatry |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm safety of and to explore the efficacy of [11C]ketoprofen methyester as a PET drug to image inflammatory process of Alzheimer's disease.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Safety, Brain PET image
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
PET imaging with [11C]PiB and [11C]ketoprofen methylester
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy or diagnosed as mild Alzheimer's disease or mild cognitive impairment based on history, physical examination, blood test, MRI, and neuropsychological tests including MMSE, LMII, GDS, CDR and MoCA-J for all subjects and some additional tests for patients.
Key exclusion criteria
Peptic ulcer. Cerebrovascular disorder. Heart failure. Disease in blood, liver or kidney. Drug or food allergy. Possibility of pregnancy. MRI contraindication. Those judged by the investigator to be inappropriate as a participant of this study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michio Senda |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Molecular Imaging
Zip code
Address
2-2, Minatojima Minamimachi, Chuo-ku, Kobe, 650-0047 Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Molecular Imaging
Zip code
Address
2-2 Minatojima Minamimachi Chuo-ku, Kobe, 650-0047 Japan
TEL
Homepage URL
Sponsor or person
Institute
Division of Molecular Imaging, Institute
of Biomedical Research and Innovation
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
RIKEN
Kobe University Hospital
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
公益財団法人先端医療振興財団 先端医療センター
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 08 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Completed
Date of protocol fixation
| 2012 | Year | 08 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 20 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 16 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 11 | Day |
Last modified on
| 2013 | Year | 08 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010194
