UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017836 |
|---|---|
| Receipt number | 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 10:20:40 |
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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
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
ysunada@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki Medical School
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020666
