Subjective Cognitive Decline (SCD)Olfactory DysfunctionMild Cognitive Impairment (MCI)ELDERLY PEOPLE
Investigational drug(s) / intervention(s)
Modified olfactory training deviceConventional olfactory training device
Modified olfactory training device: Participants will use a modified olfactory training device based on expiratory pressure. The advantages of the improved device are as follows: bi-directional airflow, positive pressure and the function of voice prompts and automatic counting.
Conventional olfactory training device: This device involves four brown glass jars (total volume 5 mL) with one of the four odors in each (1mL each, soaked in cotton pads to prevent spilling). The following odors were used: phenyl ethyl alcohol (PEA): rose, menthol: mint, citronellal: lemon, and eugenol: cloves. All jars were labeled with the odor name.
Study summary
The goal of this clinical trial is to validate the effectiveness of the modified olfactory training device, the main questions it aims to answer are: Is it possible that the device can delay the progression of MCI in older adults? Compared to the conventional device, how efficient is the modified olfactory training device for improving cognitive function?
Eligibility
Sex
ALL
Min age
60 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age and Gender: Individuals aged 60-80 years, regardless of gender.
2. Diagnosis of Idiopathic Olfactory Dysfunction: overall TDI score below 30.75 points using the Sniffin' Sticks test. Without olfactory impairment due to traumatic, sinusitis-related, congenital, toxic/drug-induced causes, post-operative conditions, tumors, or post-upper respiratory infections.
3. Diagnosis of Subjective Cognitive Decline: Montreal Cognitive Assessment (MoCA) score \>24 for middle school level and above, \>19 for elementary school level, and \>13 for illiterate individuals. Amyloid β (Aβ) deposition in the brain (defined as Aβ42 \< 550 ∼ 813 pg/ml)， the higher Formula of Hulstaert (defined as \[(Aβ42/(240 + 1.18 × tau) ≤1\]）, and hippocampus atrophy.
4. Consent: Willingness to sign an informed consent form.
Exclusion Criteria:
1. Comorbid Chronic Diseases or Severe Concurrent Illnesses: Individuals with conditions such as hypertension, diabetes, bronchopneumonia, malignant tumors， or chronic obstructive pulmonary disease.
4\. Recent Medication Use: Exclusion of participants who have taken corticosteroids, antimicrobials, leukotriene antagonists, or antihistamines within the last four weeks.
5\. Inability to Comply with Study Requirements: Based on the researcher's judgment, individuals who are unable to tolerate olfactory function tests and treatment， complete the study or comply with its requirements due to memory or behavioral abnormalities, depression, severe alcohol consumption, or previous non-compliance.
Primary outcome measure(s)
Montreal Cognitive Assessment (MoCA) score — Baseline,Month 3,Month 6,Month 12,Month 24 The MoCA score will be used to evaluate cognitive function across several domains including memory, attention, language, and orientation.
Biomarkers of cognition (Blood/CSF) — Baseline,Month 3,Month 6,Month 12,Month 24 This measure includes plasma and CSF levels of UGOT p-tau217, CSF Aβ42, p-tau181, total tau, and amyloid β 42 to total tau ratios. These biomarkers will help in assessing the biochemical progression of cognitive impairment.
Neuroimaging assessments — Baseline,Month 3,Month 6,Month 12,Month 24 This includes MRI scans focusing on temporal lobes and other brain regions, and amyloid PET scans to detect amyloid plaques. These imaging techniques will provide insights into structural and functional changes in the brain associated with cognitive decline.
The Sniffin' Sticks test — Baseline,Month 3,Month 6,Month 12,Month 24 a clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification（TDI)( more than 6 scores)
Trial sites (1)
Facility
City
Region
Status
Dawei Wu
Beijing
Beijing Municipality
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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