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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008674
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Division of Molecular Imaging, 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 Hospital
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010194

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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