Olfactory Neuroepithelial Tissue of Alzheimer Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Olfactory Biopsies

NCT07021040

Alzheimer Disease Smell Loss Smell Dysfunction

RECRUITING NA

Smell, Voice and Nasal Swabs as Markers for Neuro-degenerative Disorders

NCT03299062

Alzheimer Disease Neurodegenerative Diseases

COMPLETED NA

Feasibility of a Method for Analysis of Alzheimer´s Disease Specific Proteins in Nasal Secretion

NCT05791552

Nasal Secretion Alzheimer Disease Brain Nose Interface

UNKNOWN NA

Study for the Tolerability of Exelon Patch (Rivastigmine) for Alzheimer's Disease (AD) Patients

NCT01312363

Alzheimer's Disease

COMPLETED

Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine

NCT01380288

Alzheimer's Disease

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CDR (Clinical dementia rating) 0

10 participants complaining subjective memory problem and acquiring CDR 0

No interventions assigned to this group

CDR 0.5

10 participants complaining subjective memory problem and acquiring CDR 0.5

No interventions assigned to this group

CDR 1

10 participants with mild cognitive impairment and acquiring CDR 1

No interventions assigned to this group

CDR 2

10 participants with moderate to severe cognitive impairment and acquiring CDR 2

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No