UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010522 |
|---|---|
| Receipt number | 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 13:23:19 |
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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
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
nookamura@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012301
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