UMIN-CTR Clinical Trial

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

Condition
Condition	mild cognitive impairment, Alzheimer's disease, corticobasal degeneration, progressive supranuclear palsy, frontotemporal dementia, dementia with Lewy bodies and Parkinson's disease and healthy volunteers
Classification by specialty	Neurology Geriatrics Psychiatry Radiology Neurosurgery Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Differential diagnosis and pathophysiological investigation of dementia using tau-imaging PET tracer [18F]THK-5351
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Distribution of tau-imaging PET tracer [18F]THK-5351
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 PET or PET/CT studies will be performed in the patients and healthy volunteers. PET images of the brain will be acquired for 90 min after intravenous injection of 2-5 MBq/kg [18F]THK-5351.
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	1) mild cognitive impairment, Alzheimer's disease, corticobasal degeneration, progressive supranuclear palsy, frontotemporal dementia, dementia with Lewy bodies and Parkinson's disease 2) 20 years of age or older at the time of obtaining consent
Key exclusion criteria	1) Pregnant, possibly pregnant or lactating women 2) Subject who is facing a life crisis 3) Subject who was judged by the investigator to be inappropriate as a participant in this study
Target sample size	210

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Nishiyama
Organization	Faculty of Medicine, Kagawa University
Division name	Department of Radiology
Zip code	7610793
Address	1750-1 Ikenobe, Miki-cho, Kita-gun Kagawa
TEL	087-898-5111
Email	nisiyosi@med.kagawa-u.ac.jp

Public contact
Name of contact person	1st name Yuka Middle name Last name Yamamoto
Organization	Faculty of Medicine, Kagawa University
Division name	Department of Radiology
Zip code	7610793
Address	1750-1 Ikenobe, Miki-cho, Kita-gun Kagawa
TEL	087-898-5111
Homepage URL
Email	yuka@med.kagawa-u.ac.jp

Sponsor
Institute	Kagawa University
Institute
Department

Funding Source
Organization	Kagawa University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Kagawa University
Address	1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel	0878985111
Email	yuka@med.kagawa-u.ac.jp

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

Other administrative information
Date of disclosure of the study information	2021 Year 03 Month 25 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	2017 Year 11 Month 01 Day
Date of IRB	2017 Year 10 Month 10 Day
Anticipated trial start date	2021 Year 03 Month 25 Day
Last follow-up date	2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 03 Month 25 Day
Last modified on	2022 Year 03 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032344