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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000021792
Receipt No. R000025134
Scientific Title Examination of the relationship between Alzheimer's disease and arteriosclerosis
Date of disclosure of the study information 2016/04/07
Last modified on 2018/04/09

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Basic information
Public title Examination of the relationship between Alzheimer's disease and arteriosclerosis
Acronym Examination of the relationship between Alzheimer's disease and arteriosclerosis
Scientific Title Examination of the relationship between Alzheimer's disease and arteriosclerosis
Scientific Title:Acronym 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
1st name
Middle name
Last name Katsuya Urakami
Organization School of Health Science, Faculty of Medicine, Tottori University
Division name Department of Biological Regulation
Zip code
Address 86 Nishicho, Yonago, Tottori, Japan
TEL 0859-38-6354
Email kurakami@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Minoru Kouzuki
Organization School of Health Science, Faculty of Medicine, Tottori University
Division name Department of Biological Regulation
Zip code
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)

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 04 Month 07 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 Completed
Date of protocol fixation
2016 Year 04 Month 06 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000025134

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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