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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010522
Receipt No. R000012301
Scientific Title Clinical evaluation of tau-imaging PET tracer [18F]THK-5117 in Alzheimer's disease patients
Date of disclosure of the study information 2013/05/01
Last modified on 2015/11/18

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Basic information
Public title Clinical evaluation of tau-imaging PET tracer [18F]THK-5117 in Alzheimer's disease patients
Acronym Clinical evaluation of [18F]THK-5117 in Alzheimer's disease patients
Scientific Title Clinical evaluation of tau-imaging PET tracer [18F]THK-5117 in Alzheimer's disease patients
Scientific Title:Acronym Clinical evaluation of [18F]THK-5117 in Alzheimer's disease patients
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 clinical study is aimed at evaluating the clinical usefulness of [18F]THK-5117 as tau-imaging radiotracer, by the comparison with amyloid PET tracer [11C]PiB in Alzheimer's disease patients and healthy normal subjects. In addition, this study is aimed at evaluating the radiation exposure level of [18F]THK-5117 PET in humans.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Regional [18F]THK-5117 retention in the brain, referenced to cerebellar cortex
2. Regional [11C]PiB retention in the brain, referenced to cerebellar cortex
3. Effective dose after administration of [18F]THK-5117
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-5117 and [11C]PiB PET scans will be performed in 8 healthy normal subjects and 8 Alzheimer's disease patients.
Both PET scans will be performed within 3 months interval.
[18F]THK-5117 PET study: After 185 MBq of [18F]THK-5117 will be intravenously injected, dynamic PET images of the brain will be acquired for 90 min.
[11C]PiB PET study: After 296 MBq of [11C]PiB will be intravenously injected, dynamic PET images of the brain will be acquired for 70 min.
For the evaluation of radiation exposure of [18F]THK-5117, whole body PET scan will be performed in one healthy normal subject for 120 min after intravenous administration of [18F]THK-5117.
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
50 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Healthy normal subjects without cognitive impairment or 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 17

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 022-717-8056
Homepage URL
Email nookamura@med.tohoku.ac.jp

Sponsor
Institute Tohoku University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology; MEXT
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s) Kudo Laboratory, Clinical Research, Innovation and Education Center, Tohoku University Hospital

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

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 01 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
2013 Year 04 Month 17 Day
Date of IRB
Anticipated trial start date
2013 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
2013 Year 04 Month 17 Day
Last modified on
2015 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012301

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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