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Olfactory Neuroepithelial Tissue of Alzheimer Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02129452
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : May 27, 2015
Information provided by (Responsible Party):
Kon Chu, Seoul National University Hospital

Brief Summary:
The purpose of this study is to evaluate the olfactory neuroepithelium as a biomarker of Alzheimer disease. The early diagnosis of Alzheimer disease is of importance for obtaining better response to treatment, but recently reported biomarkers have some limitations. Olfactory neuroepithelium tissue which is accessible through office-based biopsy without difficulty is known to reflect brain pathology that confirms the diagnosis of Alzheimer disease. This study will help in the early detection and treatment of Alzheimer disease.

Condition or disease
Alzheimer Disease

Detailed Description:

Alzheimer disease is the most common form of dementia characterized by insidious onset and slow progression. Pathological changes in the brain of Alzheimer disease (AD) precede clinical symptoms many years, and early treatment provide better outcome. Consequently, detection of AD in early stages is needed. Biologic markers including beta-amyloid and tau protein have been studied for early diagnosis of AD. Recently remarkable biomarkers have drawn attention including CSF proteins and PIB (Amyloid-binding carbon 11-labeled Pittsburgh compound B) PET findings, but they pertain to supportive markers since they reflect brain pathology indirectly.

Postmortem studies of AD patients revealed that beta-amyloid and tau proteins are found in olfactory neuroepithelium and correlate with brain pathological changes. Olfactory neuroepithelium tissue can be obtained through office-based biopsy safely and easily by nasal endoscopy. Especially, early pathological changes of AD can be found in entorhinal cortex and piriform cortex adjacent to olfactory neuroepithelium, this study would be valuable for early detection of AD.

MicroRNAs are small, single-stranded RNA comprising about 20 nucleotides and involved in cell differentiation, growth and death. Recently the investigators reported that microRNA 206 have important role in pathomechanism of AD, thus can be new biomarker and disease-modifying therapeutic target of AD.

Study participants are enrolled from primary care clinic at department of Neurology, Seoul National University Hospital. Patients' clinical presentation, MMSE (Mini mental status exam), CDR (Clinical Dementia Rating) and ADAS-COG-K (Alzheimer Disease Assessment Scale Cognitive Subscale) are collected from routinely executed exams in the clinic. Participants are categorized into four groups according to CDR, and each group enrolls 10 patients respectively. The number of 10 patients per each group was calculated based on previous studies, costs, time and ethical perspectives.

Method for olfactory neuroepithelium biopsy was adopted from Lovell et al. (Arch Otolaryngol. 1982). Concentrations of beta-amyloid and tau proteins are analyzed from ELISA, and microRNA 206 from RT-PCR, northern blot and microarray. These data will be evaluated with clinical features and exam results of participants using general statistical methods.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Research of Olfactory Neuroepithelial Tissue as a Potential Biomarker of Alzheimer Disease
Study Start Date : January 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

CDR (Clinical dementia rating) 0
10 participants complaining subjective memory problem and acquiring CDR 0
CDR 0.5
10 participants complaining subjective memory problem and acquiring CDR 0.5
10 participants with mild cognitive impairment and acquiring CDR 1
10 participants with moderate to severe cognitive impairment and acquiring CDR 2

Primary Outcome Measures :
  1. Pathological evidence of Alzheimer disease in the olfactory neuroepithelium [ Time Frame: Baseline at the time of enrollment. Data will be evaluated in a month. ]
    beta-amyloid protein, tau protein and micro-RNA 206 concentration according to disease progression

Biospecimen Retention:   Samples With DNA
Tissue including olfactory neuroepithelium from nasal cavity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
primary care clinic

Inclusion Criteria:

  • "Probable" Alzheimer disease categorized according to NINCDS-ADRDA criteria
  • Written or signed informed consent obtained voluntarily from the subject, or legally acceptable representative(s) in the case of "Vulnerable subjects" with CDR more than 1

Exclusion Criteria:

  • Those who are not eligible for nasal cavity biopsy due to behavioral or movement disorder
  • Those who are in a hypercoagulable state or who take anticoagulant drugs
  • Those who have chronic or active allergic rhinitis which interfere accurate pathological evaluation
  • Those who are not suitable for the study to the judgments of researchers

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02129452

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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
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Principal Investigator: Kon Chu, MD, PhD Seoul National University Hospital

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Responsible Party: Kon Chu, MD, PhD, professor, Seoul National University Hospital Identifier: NCT02129452    
Other Study ID Numbers: 1301056458
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Keywords provided by Kon Chu, Seoul National University Hospital:
Alzheimer disease
Neurodegenerative Diseases
Amyloid beta Peptides
Amyloid Plaque
Early Diagnosis
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders