UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014117 |
|---|---|
| Receipt number | R000016432 |
| Scientific Title | Clinical study of diagnostic method for dementia using samples from nasal cavity (1) - study on sampling sites and pre-treatment methods - |
| Date of disclosure of the study information | 2014/06/01 |
| Last modified on | 2017/12/01 13:06:33 |
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Basic information
Public title
Clinical study of diagnostic method for dementia using samples from nasal cavity (1) - study on sampling sites and pre-treatment methods -
Acronym
Clinical study of diagnostic method for dementia using samples from nasal cavity (1)
Scientific Title
Clinical study of diagnostic method for dementia using samples from nasal cavity (1) - study on sampling sites and pre-treatment methods -
Scientific Title:Acronym
Clinical study of diagnostic method for dementia using samples from nasal cavity (1)
Region
| Japan |
Condition
Condition
Alzheimer's disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study on sampling sites and pretreatment methods for measuring Abeta and tau from nasal cavity
Basic objectives2
Others
Basic objectives -Others
usefulness
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessments of effectiveness: Using samples from nasal cavity of patients of Alzheimer's disease and normal control;
1. Determine sampling sites such as olfactory cleft, middle nasal meatus, inferior nasal concha, and common nasal meatus for comparing AD patients with controls.
2. Examine a possibility of simultaneous detection of Abeta and tau with pretreatment method developed by Panasonic Healthcare Co., Ltd.
Safety evaluations: Evaluate frequency of occurrence and seriousness of adverse events, problem of apparatus, and side effects.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients with Alzheimer' s disease and control cases are selected by clinical symptoms, psychological tests and imaging used in J-ADNI study.
2. More than 60-year-old.
3. Informed consent by the patient or guardian.
Key exclusion criteria
1. People having nose disease such as sinusitis and allergic rhinitis.
2. People with bleeding tendency.
3. People who can not take MRI examination.
4. Patients who were judged inappropriate for this study by the investigator.
Target sample size
50
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 Tsukinowo-cho, Otsu
TEL
077-548-2330
kinchan@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 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
TEL
077-548-2330
Homepage URL
kinchan@belle.shiga-med.ac.jp
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
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
滋賀医科大学医学部附属病院（滋賀県）
Other administrative information
Date of disclosure of the study information
| 2014 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 25 | Day |
Date trial data considered complete
| 2016 | Year | 08 | Month | 12 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
Collection of nasal samples.
Samples are collected with a swab from olfactory cleft, middle nasal meatus, inferior nasal concha, and common nasal meatus of the left and right nasal cavities.
Management information
Registered date
| 2014 | Year | 05 | Month | 30 | Day |
Last modified on
| 2017 | Year | 12 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016432
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
