UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020512
Receipt number R000023677
Scientific Title Investigation of mild cognitive impairment using 11C-PiB
Date of disclosure of the study information 2016/05/01
Last modified on 2016/03/23 00:01:36

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Basic information

Public title

Investigation of mild cognitive impairment using 11C-PiB

Acronym

Imaging diagnosis of MCI using 11C-PiB

Scientific Title

Investigation of mild cognitive impairment using 11C-PiB

Scientific Title:Acronym

Imaging diagnosis of MCI using 11C-PiB

Region

Japan


Condition

Condition

mild cognitive impairment

Classification by specialty

Radiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Analysis of pathophysiology including amyloid deposition in mild cognitive impairment

Basic objectives2

Others

Basic objectives -Others

efficiency of amyloid deposition for early diagnosis

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Relationship of amyloid deposition with MCI

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

35 years-old <=

Age-upper limit

120 years-old >

Gender

Male and Female

Key inclusion criteria

Acceptance of informed consent

Key exclusion criteria

Possibility of pregnancy

Target sample size

125


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kazunari Ishii

Organization

Neurocognitive Disorders Center, Kinki University Hospital

Division name

Radiology

Zip code


Address

377-2, Ohno-higashi, Osakasayama

TEL

072-366-0221

Email

ishii@med.kindai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kazunari Ishii

Organization

Neurocognitive Disorders Center, Kinki University Hospital

Division name

Radiology

Zip code


Address

377-2, Ohno-higashi, Osakasayama

TEL

072-366-0221

Homepage URL


Email

ishii@med.kindai.ac.jp


Sponsor or person

Institute

Kinki University Faculty of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kinki 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


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



Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 01 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

Preinitiation

Date of protocol fixation

2015 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2016 Year 04 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

The examination has not yet started.


Management information

Registered date

2016 Year 01 Month 08 Day

Last modified on

2016 Year 03 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023677


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name