UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036210
Receipt number R000041240
Scientific Title Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging
Date of disclosure of the study information 2019/04/18
Last modified on 2019/04/18 09:13:58

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Basic information

Public title

Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging

Acronym

Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging

Scientific Title

Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging

Scientific Title:Acronym

Longitudinal study 2 across the spectrum of Alzheimer's disease associated with amyloid PET Imaging

Region

Japan


Condition

Condition

Alzheimer's disease

Classification by specialty

Neurology Psychiatry Radiology
Adult

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

The aim is to evaluate preclinical AD and MCI due to AD using PET amyloid imaging as a beta amyloid biomarker,and to clarify the progression of pre-symptomatic stage to AD dementia.

Basic objectives2

Others

Basic objectives -Others

Understanding of the pathology

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

1)To investigate the deposits of beta-amyloid in brain cortex.
2)Degree of impairment of cognitive function correlate with beta-amyloid.

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

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine Device,equipment

Interventions/Control_1

Three-dimensional Dynamic PET images of the brain will be acquired for 60min after intravenous administration of [11C-PIB](about 550 mBq ).

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

90 years-old >=

Gender

Male and Female

Key inclusion criteria

Written informed consent was obtained from patient or his/her family.

Key exclusion criteria

The past or present history of psychiatric, disorders, cerebrovascular disease, degenerative disease of the brain and head injury.

Target sample size

160


Research contact person

Name of lead principal investigator

1st name Shizuo
Middle name
Last name Hatashita

Organization

Shonan Atsugi Hospital

Division name

Neurosurgery

Zip code

243-8551

Address

Nukumizu118-1 Atsugi-City, Kanagawa, Japan

TEL

046-223-3636

Email

tiken2@shonan-atsugi.jp


Public contact

Name of contact person

1st name Shizuo
Middle name
Last name Hatashita

Organization

Shonan Atsugi Hospital

Division name

Neurosurgery

Zip code

243-8551

Address

Nukumizu118-1 Atsugi-City, Kanagawa, Japan

TEL

046-223-3636

Homepage URL


Email

tiken2@shonan-atsugi.jp


Sponsor or person

Institute

Shonan Atsugi Hospital

Institute

Department

Personal name



Funding Source

Organization

None

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

Tokushukai Group Ethical Comittee

Address

1-8-7, Koji-machi, Chiyoda-ku, Tokyo

Tel

03-3263-4801

Email

mirai-ec1@mirai-iryo.com


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

2019 Year 04 Month 18 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

Open public recruiting

Date of protocol fixation

2019 Year 03 Month 14 Day

Date of IRB

2019 Year 04 Month 15 Day

Anticipated trial start date

2019 Year 04 Month 18 Day

Last follow-up date

2025 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

2019 Year 03 Month 15 Day

Last modified on

2019 Year 04 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041240


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name