UMIN-CTR Clinical Trial

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
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

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
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Results Delayed
Results Delay Reason
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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

Research Plan
Registered date	File name

Research case data specifications
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Research case data
Registered date	File name

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