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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027015
Receipt No. R000030973
Scientific Title Exosome analysis of Alzheimer's type dementia to predict onset factor and clinical biomarker
Date of disclosure of the study information 2017/06/01
Last modified on 2017/04/17

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Basic information
Public title Exosome analysis of Alzheimer's type dementia to predict onset factor and clinical biomarker
Acronym Exosome analysis of Alzheimer's type dementia
Scientific Title Exosome analysis of Alzheimer's type dementia to predict onset factor and clinical biomarker
Scientific Title:Acronym Exosome analysis of Alzheimer's type dementia
Region
Japan

Condition
Condition Alzheimer's type dementia
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Exosome analysis of Alzheimer's type dementia to predict onset factor and clinical biomarker
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of onset factor and clinical biomarkers of Alzheimer's type dementia
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
40 years-old <=
Age-upper limit
85 years-old >
Gender Male and Female
Key inclusion criteria Patients diagnosed clinically as AD or MCI or normal healthy subjects.
Key exclusion criteria Lewy body disease, cerebrovascular dementia, normal pressure hydrocephalus and psychosis patients
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukifusa Igeta
Organization Toranomon Hospital
Division name Dept. of General Geriatric Medicine
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo,105-8470,Japan
TEL 03-3588-1111
Email igeta@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yukifusa Igeta
Organization Toranomon Hospital
Division name Dept. of General Geriatric Medicine
Zip code
Address 2-2-2 Toranomon, Minato-ku, Tokyo,105-8470,Japan
TEL 03-3588-1111
Homepage URL
Email igeta@toranomon.gr.jp

Sponsor
Institute Toranomon Hospital
Institute
Department

Funding Source
Organization Toranomon Hospital
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
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
2017 Year 06 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
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Blood test and cerebrospinal fluid test will be performed.

Management information
Registered date
2017 Year 04 Month 17 Day
Last modified on
2017 Year 04 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030973

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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