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?
Age and Gender: Individuals aged 60-80 years, regardless of gender.
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.
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.
Consent: Willingness to sign an informed consent form.
Comorbid Chronic Diseases or Severe Concurrent Illnesses: Individuals with conditions such as hypertension, diabetes, bronchopneumonia, malignant tumors， or chronic obstructive pulmonary disease.
Parallel
Modified olfactory training device
Combination productParticipants 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
Combination productThis 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.
Montreal Cognitive Assessment (MoCA) score
The MoCA score will be used to evaluate cognitive function across several domains including memory, attention, language, and orientation.
Biomarkers of cognition (Blood/CSF)
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
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
a clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification（TDI)( more than 6 scores)
Auditory Verbal Learning Test (AVLT)
Evaluates immediate memory recall, learning rate, and delayed recall, providing insights into verbal learning and memory.
Digit Span Test (DST)
Assesses attention and working memory through forward and backward number recall tasks.
Trail Making Test (TMT)
Measures visual attention and task switching by requiring participants to connect a sequence of numbers and letters as quickly as possible.
Clock Drawing Test (CDT)
Used to assess visual-spatial abilities and executive function by having participants draw a clock showing a specific time.
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Peking University Third Hospital
Lead sponsor
Peking University Sixth Hospital
Collaborator
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