UMIN-CTR Clinical Trial

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

Condition
Condition	Alzheimer's disease, Mild cognitive impairment, healthy volunteers, Frontotemporal lobe degeneration, Progressive Supranuclear Palsy and Dementia with Lewy body.
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 sequential changes in the spatial distribution of tau PET tracer [18F]THK5351 and its association with cognitive decline in patients with Alzheimer's disease, mild cognitive decline, healthy volunteers and the other tauipathies.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The annual change in the [18F]THK-5351 retention in the brain.
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 and healthy volunteers. PET images of the brain will be acquired from 40 to 60 min after intravenous administration of 185 mBq [18F]THK-5351, and from 50 to 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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	probable AD (NINCDS-ADRDA Working Group) Mild Cognitive Impairment (petersen's criteria) Frontotemporal Lobar Degeneration (Neary's criteria) Progressive Supranuclear Palsy (NINDS-SPSP International Workshop) Dementia with Lewy Body (McKeith's criteria) Healthy normal subjects without cognitive impairment
Key exclusion criteria	Subjects with neuropsychiatric diseases other than inclusion ariteria, subjects with severe cardiac abnormalities, and subjects with pacemaker or metal device in the body.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Tomita
Organization	Tohoku University Hospital
Division name	Department of Geriatric Medicine and Neuroimaging
Zip code	9808575
Address	4-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7182
Email	naoki.tomita.b1@tohoku.ac.jp

Public contact
Name of contact person	1st name Aiko Middle name Last name Ishiki
Organization	Tohoku University Hospital
Division name	Department of Geriatric Medicine and Neuroimaging
Zip code	9808575
Address	4-1 Seiryo-machi, Aoba-ku, Sendai
TEL	022-717-7182
Homepage URL
Email	aiko.ishiki.e1@tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Clinical Research Review Board, Tohoku University
Address	4-1 Seiryo-machi, Aoba-ku, Sendai
Tel	022-728-4105
Email	ec@rinri.hosp.tohoku.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	2016 Year 10 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	2016 Year 10 Month 18 Day
Date of IRB	2016 Year 09 Month 27 Day
Anticipated trial start date	2016 Year 10 Month 24 Day
Last follow-up date	2017 Year 12 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date	2016 Year 10 Month 24 Day
Last modified on	2020 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028226