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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000017836
Receipt No. R000020666
Scientific Title Molecular and therapeutic apploaches of autosomal recessive familial Alzheimer's disease using APPE693dlta-iPS cells.
Date of disclosure of the study information 2015/06/08
Last modified on 2016/05/19

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Basic information
Public title Molecular and therapeutic apploaches of autosomal recessive familial Alzheimer's disease using APPE693dlta-iPS cells.
Acronym Analysis of disease-causing mutant APP (E693delta) iPS cells
Scientific Title Molecular and therapeutic apploaches of autosomal recessive familial Alzheimer's disease using APPE693dlta-iPS cells.
Scientific Title:Acronym Analysis of disease-causing mutant APP (E693delta) iPS cells
Region
Japan

Condition
Condition Familial Alzheimer's disease(APP E693delta).
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Establishment of the iPS cells from a patient with familial Alzheimer's disease(APP E693delta).
Basic objectives2 Others
Basic objectives -Others Screening of small-molecule inhibitors preventing familial Alzheimer's disease(APP E693delta).
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes Establishment of the iPS cells from a patient with familial Alzheimer's disease(APP E693delta).
Key secondary outcomes Screening of small-molecule inhibitors preventing familial Alzheimer's disease(APP E693delta).

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 Treatment
Type of intervention
Gene
Interventions/Control_1 Introduction of Yamanaka's factor into patient-derived somatic cells.
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
60 years-old >=
Gender Female
Key inclusion criteria Patients havoring APP-E693delta
Key exclusion criteria none
Target sample size 1

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihide Sunada
Organization Kawasaki Medical School
Division name Neurology
Zip code
Address 577 Matsushima, Kurashiki, Okayama
TEL 0864621111
Email ysunada@med.kawasaki-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihide Sunada
Organization Kawasaki Medical School
Division name Neurology
Zip code
Address 577 Matsushima, Kurashiki, Okayama
TEL 0864621111
Homepage URL
Email ysunada@med.kawasaki-m.ac.jp

Sponsor
Institute Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
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
2015 Year 06 Month 08 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 No longer recruiting
Date of protocol fixation
2015 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 08 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
2015 Year 06 Month 08 Day
Last modified on
2016 Year 05 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020666

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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