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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024509
Receipt No. R000028213
Scientific Title Investigation of diagnostic biomarkers for dementia
Date of disclosure of the study information 2016/11/01
Last modified on 2019/04/23

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Basic information
Public title Investigation of diagnostic biomarkers for dementia
Acronym Investigation of diagnostic biomarkers for dementia
Scientific Title Investigation of diagnostic biomarkers for dementia
Scientific Title:Acronym Investigation of diagnostic biomarkers for dementia
Region
Japan

Condition
Condition Mild cognitive impairment, Alzheimer's disease, Vascular dementia, Frontotemporal dementia, Dementia with Lewy Bodies and Normal controls
Classification by specialty
Psychiatry Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 The aim of this study is to investigate diagnostic biomarkers for dementia using biological samples.
Basic objectives2 Others
Basic objectives -Others The objective of this study is to reveal clinical characteristics of biological samples.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessments of clinical dementia symptoms, blood and saliva samples for comparison of subjects with dementia and normal controls.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with diagnoses of mild cognitive impairment, Alzheimer's disease, vascular dementia, frontotemporal dementia, dementia with Lewy Bodies, who are inpatients or outpatients. Also, normal controls aged 20 and over, who have not been diagnosed with dementia.
Key exclusion criteria Severe physical illness
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Kazuhiro
Middle name
Last name Kondo
Organization The Jikei University School of Medicine
Division name Department of Virology
Zip code 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL 03-3433-1111
Email kkondo@jikei.ac.jp

Public contact
Name of contact person
1st name Nobuyuki
Middle name
Last name Kobayashi
Organization The Jikei University School of Medicine
Division name Department of Virology
Zip code 105-8461
Address 3-25-8, Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
TEL 03-3433-1111
Homepage URL
Email kkondo@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) The Uehara Memorial Foundation and Mitsui Life Social Welfare Foundation

IRB Contact (For public release)
Organization the Ethics Committees of the Jikei University School of Medicine
Address 3-25-8 Nishi-Shimbashi, Minato-ku, Tokyo 105-8461, Japan
Tel 03-3433-1111
Email rinri@jikei.ac.jp

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 東京慈恵会医科大学附属病院(東京都)、医療法人永光会あいらの森ホスピタル(旧栗野病院)(鹿児島県)/
The Jikei University Hospital (Tokyo), Eiko-kai healthcare corporation Kurino hospital (Kagoshima)

Other administrative information
Date of disclosure of the study information
2016 Year 11 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 Enrolling by invitation
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
2016 Year 02 Month 01 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information case-control study

Management information
Registered date
2016 Year 10 Month 21 Day
Last modified on
2019 Year 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028213

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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