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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013929
Receipt No. R000016242
Scientific Title Clinical evaluation of tau-imaging PET tracer [18F]THK-5351
Date of disclosure of the study information 2014/05/19
Last modified on 2018/05/15

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Basic information
Public title Clinical evaluation of tau-imaging PET tracer [18F]THK-5351
Acronym Clinical evaluation of PET tracer [18F]THK-5351
Scientific Title Clinical evaluation of tau-imaging PET tracer [18F]THK-5351
Scientific Title:Acronym Clinical evaluation of PET tracer [18F]THK-5351
Region
Japan

Condition
Condition Alzheimer's disease and healthy volunteer
Classification by specialty
Neurology Geriatrics Psychiatry
Radiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study is aimed at evaluating the clinical usefulness of [18F]THK-5351 as a PET tracer for tau imaging, by the comparison with amyloid PET tracer [11C]PiB in the patients with Alzheimer's disease and healthy volunteers.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Regional [18F]THK-5351 and [11C]PiB retention in the brain, referenced to cerebellar cortex.
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
Interventions/Control_1 [18F]THK-5351 and [11C]PiB PET studies will be performed in the patients with Alzheimer's disease and healthy volunteers. Both PET scans will be performed within 3 months interval.
Dynamic PET images of the brain will be acquired for 90 min after intravenous administration of 185 mBq [18F]THK-5351, and for 70 min after intravenous administration of 296 MBq [11C]PiB.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy normal subjects without cognitive impairment and cerebrovascular lesion, and probable Alzheimer's disease patients (NINCDS-ADRDA criteria)
Key exclusion criteria Subjects with neuropsychiatric diseases other than Alzheimer's disease, subjects with severe cardiac abnormalities, and subjects with pacemaker or metal device in the body.
Target sample size 19

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuyuki Okamura
Organization Tohoku University School of Medicine
Division name Department of Pharmacology
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-8058
Email nookamura@med.tohoku.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuyuki Okamura
Organization Tohoku University School of Medicine
Division name Department of Pharmacology
Zip code
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL 022-717-8058
Homepage URL
Email nookamura@med.tohoku.ac.jp

Sponsor
Institute Tohoku University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
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 東北大学サイクロトロンRIセンター、東北大学病院

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 19 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 Completed
Date of protocol fixation
2014 Year 05 Month 12 Day
Date of IRB
Anticipated trial start date
2014 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 12 Day
Last modified on
2018 Year 05 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016242

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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