UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study of the minimally invasive method for detecting amyloid-beta and tau protein
Title of the study (Brief title)	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

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	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	Ikuo Tooyama
Organization	Shiga University of Medical Science
Division name	Molecular Neuroscience Research Center
Address	Seta Tsukinowa-cho, Otsu, Japan
TEL	077-548-2330
Email

Public contact
Name of contact person
Organization	Shiga University of Medical Science
Division name	Molecular Neuroscience Research Center
Address	Seta Tsukinowa-cho, Otsu, Japan
TEL
Homepage URL
Email

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	Fukushimura Hospital
Name of secondary funｄer(s)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010533