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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
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 |
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 |
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Condition | ||
Condition | Alzheimer's disease | |
Classification by specialty |
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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 | |
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Purpose of intervention | |
Type of intervention | |
Interventions/Control_1 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date trial data considered complete |
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Date analysis concluded |
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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 |
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Last modified on |
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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 | |
Registered date | File name |
Research case data | |
Registered date | File name |