UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the relationship between Alzheimer's disease and arteriosclerosis
Title of the study (Brief title)	Examination of the relationship between Alzheimer's disease and arteriosclerosis
Region	Japan

Condition
Condition	Alzheimer's disease, Mild cognitive impairment, Elderly persons without cognitive impairment
Classification by specialty	Neurology Geriatrics Psychiatry
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Alzheimer's disease often have arteriosclerosis. The aim of this study is to investigate the relationship between pathophysiology of Alzheimer's disease and arteriosclerosis.
Basic objectives2	Others
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Arteriosclerosis-related tests (Flow Mediated Dilation:FMD, Arterial Pressure volume Index:API, Arterial Velocity pulse Index:AVI), cerebrospinal fluid tests, Touch Panel-type Dementia Assessment Scale(TDAS)
Key secondary outcomes	Blood tests (total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, glucose)

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	Prevention
Type of intervention	Other
Interventions/Control_1	Arteriosclerosis-related tests, cerebrospinal fluid tests, examination of cognitive function, blood tests
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	50 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Subjects who are 20-89 years old at the time of registration 2) Alzheimer's disease patients who fulfill of the DSM-5 and NINCDS-ADRDA criteria, or mild cognitive impairment patients who fulfill of the Petersen criteria, or subjects who don't have cognitive impairment. 3) In the Alzheimer's disease and mild cognitive impairment patients, the consent from proxies is necessary. 4) Patients who performed the cerebrospinal fluid and blood tests (total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride, glucose) within three months.
Key exclusion criteria	1) Patients who are judged difficulty depiction of brachial artery or pressure of forearm. 2) Patients who have more than 200 mmHg in resting systolic pressure. 3) Patients who are assessed by the principal investigator due to other reasons.
Target sample size	90

Research contact person
Name of lead principal investigator	Katsuya Urakami
Organization	School of Health Science, Faculty of Medicine, Tottori University
Division name	Department of Biological Regulation
Address	86 Nishicho, Yonago, Tottori, Japan
TEL	0859-38-6354
Email	kurakami@med.tottori-u.ac.jp

Public contact
Name of contact person	Minoru Kouzuki
Organization	School of Health Science, Faculty of Medicine, Tottori University
Division name	Department of Biological Regulation
Address	86 Nishicho, Yonago, Tottori, Japan
TEL	0859-38-6358
Homepage URL
Email	kouzuki@med.tottori-u.ac.jp

Sponsor
Institute	Department of Biological Regulation, School of Health Science, Faculty of Medicine, Tottori University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 04 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 06 Day
Anticipated trial start date	2016 Year 04 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 06 Day
Last modified on	2018 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025134