UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031729
Receipt number R000036228
Scientific Title Producing booklet for appropriate application of amyloid PET imaging in people with dementia. (Relationship between clnical symptoms and amyloid PET binding in early dementia subjects.)
Date of disclosure of the study information 2018/03/31
Last modified on 2019/06/25 21:16:30

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Basic information

Public title

Producing booklet for appropriate application of amyloid PET imaging in people with dementia. (Relationship between clnical symptoms and amyloid PET binding in early dementia subjects.)

Acronym

Producing booklet for amyloid PET imaging

Scientific Title

Producing booklet for appropriate application of amyloid PET imaging in people with dementia. (Relationship between clnical symptoms and amyloid PET binding in early dementia subjects.)

Scientific Title:Acronym

Producing booklet for amyloid PET imaging

Region

Japan


Condition

Condition

Dementia

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To produce a booklet for clinician, regarding indication for amyloid PET, imaging test which determines whether the cause of the dementia is due to Alzheimer's disease or not.

Basic objectives2

Others

Basic objectives -Others

(1)Produce referral letter for ordering amyloid PET imaging for local clinician.
(2) Produce result letter to ordering clinician.
(3) Produce a booklet for appropriate indication of amyloid PET imaging in person with dementia.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Diagnostic change of subject with dementia by result from florbetapir PET imaging.

Key secondary outcomes

Adverse effect of florbetapir PET.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Florbetapir PET scanned once.

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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Atypical clinical symptom or age of onset for dementia.
(2)Mild to moderate cognitive impairment.

Key exclusion criteria

(1)Delirium
(2)Depression
(3)Drug induced cognitive decline
(4)Pregnancy

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Shigeki
Middle name
Last name Hirano

Organization

Chiba University Hospi9tal, Chiba, Japan

Division name

Department of Neurology

Zip code

260-8670

Address

1-8-1Inohana,Chuo-ku,Chiba-shi,Chiba260-8670,Japan

TEL

043-226-2736

Email

s_hirano@chiba-u.jp


Public contact

Name of contact person

1st name Shigeki
Middle name
Last name Hirano

Organization

Chiba University Hospital

Division name

Clinical Trial Department

Zip code

260-8670

Address

1-8-1Inohana,Chuo-ku,Chiba-shi,Chiba260-8670,Japan

TEL

043-226-2736

Homepage URL


Email

s_hirano@chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

Eli Lilly Japan Ltd.

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

IRB comittee, Chiba University Hospital, Chiba, Japan

Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba, Japan

Tel

043-226-2616

Email

ayamazaki@office.chiba-u.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

千葉大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2018 Year 03 Month 31 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

15

Results

Out of 15 subjects who underwent amyloid PET, 2 corticobasal syndrome and 1 non-Alzheimer type senile dementia changed the diagnosis by the PET result.

Results date posted

2019 Year 06 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Six Alzheimer's disease, 5 corticobasal syndrome, 1 dementia with Lewy bodies, 2 non-Alzheimer type senile dementia.

Participant flow

All participants underwent neuropsychological tests and Florbetapir PET.

Adverse events

None

Outcome measures

Florbetapir PET

Plan to share IPD

Data are stocked in the data center, Chiba University Hospital.

IPD sharing Plan description

Above.


Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 03 Month 31 Day

Date of IRB

2018 Year 03 Month 14 Day

Anticipated trial start date

2018 Year 04 Month 01 Day

Last follow-up date

2019 Year 03 Month 31 Day

Date of closure to data entry

2019 Year 03 Month 31 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2018 Year 03 Month 14 Day

Last modified on

2019 Year 06 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036228


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name