UMIN-CTR Clinical Trial

Public title

Search of factors that affect beta-amyloid protein deposition in the brain on the patients with lifestyle-related diseases.

Acronym

Beta-amyloid protein deposition in the brain with lifestyle-related diseases.

Scientific Title

Search of factors that affect beta-amyloid protein deposition in the brain on the patients with lifestyle-related diseases.

Scientific Title:Acronym

Beta-amyloid protein deposition in the brain with lifestyle-related diseases.

Region

Japan

Condition

Lifestyle-related diseases such as diabetes mellitus, hypertension, dyslipidemia, and obesity.

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

In the patients with Alzheimer's disease (AD), beta-amyloid protein deposition builds up in the brain before clinical symptoms occur, and it is supposed to be important to diagnose and start treatment in the earlier stages of AD. Recent techniques of amyloid imaging can detect beta-amyloid deposition as a pathological hallmark, and some studies are continuing research into the use of those brain imaging - amyloid positron emission tomography (PET) scanning - for diagnosing AD in its early stage. Since many epidemiologic studies have indicated that lifestyle-related diseases such as diabetes mellitus, hypertension, or dyslipidemia increase the risk of developing AD so far, we conducted a cross-sectional research to investigate relationships between those lifestyle-related diseases, beta-amyloid deposition in the brain highlighted by PET scanning with the amyloid tracer carbon 11-labeled Pittsburgh Compound B ([11C]PiB), physical findings, biochemical profiles, neuropsychological functions, and genetic information of patients. The purpose of this study is to search risk factors and protective factors of pathological changes or cognitive disorder relevance to AD in patients of life-style diseases.

Basic objectives2

Others

Basic objectives -Others

This cross-sectional study does not have purpose of testing safety or efficacy of medical practice against patients, however, we will perform the examination aimed at research and not for usual medical care in this study, so we defined our project as an intervention study. The procedures of the examinations are thought to be minimally invasive for human. As for the amyloid imaging, safety of radioactive drug [11C]PiB and medical exposure in PET scanning is assured mainly in previous studies, and widely used at present.

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Results of the examinations such as [11C]PiB PET scanning, blood test, urinalysis, neuropsychological testing, or gene analysis.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Gene

Other

Interventions/Control_1

To perform minimally invasive or non-invasive examinations for the patients with lifestyle-related diseases.

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with lifestyle-related diseases such as diabetes mellitus, hypertension, dyslipidemia, and obesity, who received the guidance and agreed to the purpose of the research in writing, of their own free will.

Key exclusion criteria

Patients who withdraw agreement to the research, or who cannot accomplish the examinations for some reasons.

Target sample size

50

Name of lead principal investigator

1st name
Middle name
Last name	Takeo Kato

Organization

Yamagata University Faculty of Medicine

Division name

Department of Neurology, Metaboism, Endocrinology and Diabetology

Zip code

Address

2-2-2 Iida-Nishi, Yamagata-shi, Yamagata 990-9585, Japan

TEL

023-628-5316

Email

tkato@med.id.yamagata-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Kaoru Takase

Organization

Yamagata University Faculty of Medicine

Division name

Department of Neurology, Metaboism, Endocrinology and Diabetology

Zip code

Address

2-2-2 Iida-Nishi, Yamagata-shi, Yamagata 990-9585, Japan

TEL

023-628-5316

Homepage URL

Email

k.takase@med.id.yamagata-u.ac.jp

Institute

Yamagata University Faculty of Medicine

Institute

Department

Personal name

Organization

Yamagata University Faculty of Medicine

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

山形大学医学部附属病院（山形県）

Date of disclosure of the study information

2017

Year

04

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Date of protocol fixation

2016

Year

02

Month

15

Day

Date of IRB

Anticipated trial start date

2016

Year

10

Month

26

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

02

Month

15

Day

Last modified on

2017

Year

01

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026546