UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008982 |
|---|---|
| Receipt number | R000010533 |
| Scientific Title | Observational study of the minimally invasive method for detecting amyloid-beta and tau protein |
| Date of disclosure of the study information | 2012/09/26 |
| Last modified on | 2016/05/23 11:55:26 |
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Basic information
Public title
Observational study of the minimally invasive method for detecting amyloid-beta and tau protein
Acronym
Observational study of the minimally invasive method for detecting amyloid-beta and tau protein
Scientific Title
Observational study of the minimally invasive method for detecting amyloid-beta and tau protein
Scientific Title:Acronym
Observational study of the minimally invasive method for detecting amyloid-beta and tau protein
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the usefulness of the method for diagnosing Alzheimer's disease using levels of amyloid-beta and tau protein in the human nasal cavity as biomarkers
Basic objectives2
Others
Basic objectives -Others
usefulness
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of the levels of amyloid-beta and tau protein in the nasal cavity between young and senior normal individuals and Alzheimer's disease patients
Key secondary outcomes
1) Relationship between the aging and the levels of amyloid-beta and tau protein in the nasal cavity
2) Relationship between the score of MMSE and the levels of amyloid-beta and tau protein in the nasal cavity
3) Relationship between the blood test and the levels of amyloid-beta and tau proteins in the nasal cavity
4) Relationship the levels of amyloid-beta and tau protein between the blood and the nasal cavity
5) Relationship between the levels of amyloid-beta and tau proteins in the nasal cavity
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
People who are over 20 years old and satisfy the following (1) or (2)
(1) Probable Alzheimer's disease patients
a) Patients who are diagnosed probable Alzheimer's disease according to NIAA guideline
b) Informed consent by the patient or guardian
(2) Normal individuals or patients without any of neurological diseases (G00-G99) classified by ICD10
a) Informed consent
b) Patients who are not prescribed medicines for neurological disease
Key exclusion criteria
1) People having nose disease such as sinusitis
2) People with bleeding tendency
3) Patients who were judged inappropriate for the study by the investigator
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ikuo Tooyama |
Organization
Shiga University of Medical Science
Division name
Molecular Neuroscience Research Center
Zip code
Address
Seta Tsukinowa-cho, Otsu, Japan
TEL
077-548-2330
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shiga University of Medical Science
Division name
Molecular Neuroscience Research Center
Zip code
Address
Seta Tsukinowa-cho, Otsu, Japan
TEL
Homepage URL
Sponsor or person
Institute
Molecular Neuroscience Research Center, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Panasonic Healthcare Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fukushimura Hospital
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
滋賀医科大学（滋賀県）、パナソニックヘルスケア株式会社（愛媛県）、医療法人さわらび会福祉村病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 26 | 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
| 2012 | Year | 08 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collection of nasal samples
Samples are collected with a swab and a dedicated instrument from the middle nasal meatus and the inferior nasal concha of the left and right nasal cavities.
Management information
Registered date
| 2012 | Year | 09 | Month | 25 | Day |
Last modified on
| 2016 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010533
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
