UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of tau-imaging PET tracer [18F]THK-5351
Title of the study (Brief title)	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	Nobuyuki Okamura
Organization	Tohoku University School of Medicine
Division name	Department of Pharmacology
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	Nobuyuki Okamura
Organization	Tohoku University School of Medicine
Division name	Department of Pharmacology
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 12 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000016242