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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016486
Receipt No. 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

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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
Email 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
Email ohnishi@fbri.org

Sponsor
Institute Institute of Biomedical Research and Innovation
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016189

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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