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| Name | Class |
|---|---|
| Peking University Sixth Hospital | OTHER |
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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?
Mild Cognitive Impairment (MCI) represents an intermediary stage between normal aging and dementia, with a significant proportion of cases progressing to dementia. No simple and effective therapeutic strategies are available to halt or reverse this progression. Olfactory dysfunction, a common early clinical manifestation of neurodegenerative diseases such as Alzheimer's Disease (AD), often precedes cognitive decline. Subjective Cognitive Decline (SCD) is increasingly recognized as a prodromal stage of MCI and dementia, which, together with olfactory dysfunction, provides a critical window for early intervention.
Conventional olfactory training (COT) has been shown to improve olfactory function, cognitive abilities, and brain connectivity in healthy elderly individuals, suggesting its potential to enhance neuroplasticity. Preliminary studies indicate that modified olfactory training (MOT) may yield superior outcomes compared to COT, with higher rates of olfactory recovery and improved deposition in the olfactory fissure. However, the efficacy of MOT in delaying or preventing the progression of olfactory dysfunction to MCI remains unclear.
In this study, the investigators planned to recruit 114 patients and divided them into three groups for control group and olfactory training with conventional and modified devices, and validate the effectiveness of the modified device based on changes in cognitive function and the comparison of the outcomes of the three groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the Modified Olfactory Training Group | Experimental | Participants will use a modified olfactory training device based on expiratory pressure. Four odors will be used: rose, mint, lemon, and clove. Each odorant is sniffed for 10 seconds per session, with a 10-second interval between odors. Each training session lasts 5 minutes and is conducted twice daily, before breakfast and at bedtime, for a duration of two years. |
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| the Conventional Training Group | Active Comparator | Patients will receive the conventional olfactory training device. Patients had to sniff one odor for approximately 10 seconds and turn to another after a rest of 10 seconds. Each training session lasts 5 minutes and is conducted twice daily, before breakfast and at bedtime, for a duration of two years. |
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| the Control Group | No Intervention | Participants will not receive any olfactory training and will be advised to observe and wait for spontaneous recovery of olfactory function. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Modified olfactory training device | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Montreal Cognitive Assessment (MoCA) score | The MoCA score will be used to evaluate cognitive function across several domains including memory, attention, language, and orientation. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| 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. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| 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. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| The Sniffin' Sticks test | a clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification（TDI)( more than 6 scores) | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Auditory Verbal Learning Test (AVLT) | Evaluates immediate memory recall, learning rate, and delayed recall, providing insights into verbal learning and memory. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Digit Span Test (DST) |
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Inclusion Criteria:
Exclusion Criteria:
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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dawei Wu | Contact | 13522503401 | davidwuorl@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dawei Wu | Beijing | Beijing Municipality | 100191 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40812823 | Derived | Lin CY, Tan Y, Zhao D, Wu D. Assessing modified olfactory training to prevent cognitive decline in MCI high-risk individuals: a multicentre randomised controlled trial protocol in Beijing tertiary hospitals. BMJ Open. 2025 Aug 13;15(8):e100880. doi: 10.1136/bmjopen-2025-100880. |
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We will decide whether to share the individual participant data after the study.
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| Conventional olfactory training device | Combination Product | 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. |
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Assesses attention and working memory through forward and backward number recall tasks.
| Baseline,Month 3,Month 6,Month 12,Month 24 |
| 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. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Clock Drawing Test (CDT) | Used to assess visual-spatial abilities and executive function by having participants draw a clock showing a specific time. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Boston Naming Test (BNT) | Measures language function, specifically object naming ability, which is crucial for everyday communication. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Verbal Fluency Test (VFT) | Assesses cognitive flexibility and semantic memory by requiring participants to generate as many words as possible from a category in a limited time. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Activities of Daily Living Scale (ADL) | Evaluates the participant's ability to perform everyday tasks independently, reflecting functional status. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Instrumental Activities of Daily Living (IADL) | Assesses more complex daily living skills critical for independent living, such as managing finances and medication. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Neuropsychiatric Inventory (NPI) | Measures behavioral changes including depression, anxiety, aggression, and apathy among others, providing a comprehensive overview of psychological status. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Hamilton Anxiety Scale (HAMA) | Assesses the severity of anxiety symptoms, which can impact cognitive and daily functioning. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Hamilton Depression Scale (HAMD) | Used to quantify the level of depressive symptoms, aiding in the assessment of mood disorders which can co-occur with cognitive decline. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| Olfactory bulb volume | Measurement of the olfactory bulb volume using MRI to assess changes or improvements in olfactory structures which might correlate with training efficacy. | Baseline,Month 3,Month 6,Month 12,Month 24 |
| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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