UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013929
Receipt number R000016242
Scientific Title Clinical evaluation of tau-imaging PET tracer [18F]THK-5351
Date of disclosure of the study information 2014/05/19
Last modified on 2018/05/15 09:32:44

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Basic information

Public title

Clinical evaluation of tau-imaging PET tracer [18F]THK-5351

Acronym

Clinical evaluation of PET tracer [18F]THK-5351

Scientific Title

Clinical evaluation of tau-imaging PET tracer [18F]THK-5351

Scientific Title:Acronym

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

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

022-717-8058

Homepage URL


Email

nookamura@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University School of Medicine

Institute

Department

Personal name



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)



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、東北大学病院


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 19 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

2014 Year 05 Month 12 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016242


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name