UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016486 |
|---|---|
| Receipt number | R000016189 |
| Scientific Title | Exploratory human PET study with 11C-(S)ketoprofen methyl ester, a potential biomarker of neuroinflammatory processes for Alzheimer's disease |
| Date of disclosure of the study information | 2015/02/09 |
| Last modified on | 2016/02/09 09:30:52 |
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Basic information
Public title
Exploratory human PET study with 11C-(S)ketoprofen methyl ester, a potential biomarker of neuroinflammatory processes for Alzheimer's disease
Acronym
KET-3
Scientific Title
Exploratory human PET study with 11C-(S)ketoprofen methyl ester, a potential biomarker of neuroinflammatory processes for Alzheimer's disease
Scientific Title:Acronym
KET-3
Region
| Japan |
Condition
Condition
Alzheimer's disease, Mild cognitive impairment, healthy
Classification by specialty
| Psychiatry | Radiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploratory human PET study of the safety and the effectiveness of [11C](S)ketoprofen methyl ester as a potential biomarker of neuroinflammatory process for Alzheimer's disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Retention and uptake of [11C](S)ketoprofen methyl ester in patients with Alzheimer's disease
Key secondary outcomes
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
3
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
The dosage in the vein of [11C] ketoprofen methylester for PET imaging.
Interventions/Control_2
The dosage in the vein of [11C] ketoprofen methylester for PET imaging.
Interventions/Control_3
The dosage in the vein of [11C] ketoprofen methylester for PET imaging.
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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Step1
1. The subject who has intention to participate in this study, and singed informed consent.
2. Age >=20 and <45 years old, with body weight >=50kgt and <85kg, and BMI >=17.6 and <26.4.
3. The subject who was judged by clinical investigator by means of physical examination and Laboratory tests to be eligible as a participant in this study.
Step2
1. The subject who has intention to participate in this study, and singed informed consent.
2. Age >=55 years old, body weight >=50kgt and <85kg, and BMI >=17.6 and <26.4.
3. The subject who was judged by clinical investigator by means of physical examination and Laboratory tests to be eligible as a participant in this study.
4.In healthy subjects, MRI findings is age-appropriate normal or there is no change to be a clinical problem.
In patients, subjects who do not have disease that causes cognitive impairment except MCI and AD by MRI.
Key exclusion criteria
1)The subject who has a peptic ulcer.
2)The subject who has blood abnormality.
3)The subject who has dysfunction in the liver / kidney.
4)The subject who has cerebrovascular disorder.
5)The subject having cardiac failure.
6)The subject with WPW or LGL syndrome, or marked bradycardia, in electrocardiogram.
7)The subject with a history of a drug or food allergy.
8)The subject who was judged by the clinical investigator to be inappropriate as a participant in this study.
Target sample size
21
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, Hyogo
TEL
078-304-5212
senda@fbri.org
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihito Ohnishi |
Organization
Institute of Biomedical Research and Innovation
Division name
Division of Molecular Imaging
Zip code
Address
2-2, Minatojima minamimachi, chuo-ku, Kobe, Hyogo
TEL
078-304-5212
Homepage URL
ohnishi@fbri.org
Sponsor or person
Institute
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
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 (兵庫県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 09 | 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
| 2014 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 30 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 09 | Day |
Last modified on
| 2016 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016189
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