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Recruitment status Completed
Unique ID issued by UMIN UMIN000014117
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email kinchan@belle.shiga-med.ac.jp

Sponsor
Institute Molecular Neuroscience Research Center, Shiga University of Medical Science
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016432


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