ELDERLY PEOPLE, Mild Cognitive Impairment (MCI), Olfactory Dysfunction, Subjective Cognitive Decline (SCD)
Conditions
Keywords
Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD), olfactory training, elderly population, Olfactory Dysfunction
Brief 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?
Detailed description
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.
Interventions
COMBINATION_PRODUCTModified 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.
COMBINATION_PRODUCTConventional 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.
Sponsors
Peking University Sixth Hospital
Peking University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Boston Naming Test (BNT) | Baseline,Month 3,Month 6,Month 12,Month 24 | Measures language function, specifically object naming ability, which is crucial for everyday communication. |
| Verbal Fluency Test (VFT) | Baseline,Month 3,Month 6,Month 12,Month 24 | Assesses cognitive flexibility and semantic memory by requiring participants to generate as many words as possible from a category in a limited time. |
| Activities of Daily Living Scale (ADL) | Baseline,Month 3,Month 6,Month 12,Month 24 | Evaluates the participant's ability to perform everyday tasks independently, reflecting functional status. |
| Instrumental Activities of Daily Living (IADL) | Baseline,Month 3,Month 6,Month 12,Month 24 | Assesses more complex daily living skills critical for independent living, such as managing finances and medication. |
| Auditory Verbal Learning Test (AVLT) | Baseline,Month 3,Month 6,Month 12,Month 24 | Evaluates immediate memory recall, learning rate, and delayed recall, providing insights into verbal learning and memory. |
| Hamilton Anxiety Scale (HAMA) | Baseline,Month 3,Month 6,Month 12,Month 24 | Assesses the severity of anxiety symptoms, which can impact cognitive and daily functioning. |
| Hamilton Depression Scale (HAMD) | Baseline,Month 3,Month 6,Month 12,Month 24 | Used to quantify the level of depressive symptoms, aiding in the assessment of mood disorders which can co-occur with cognitive decline. |
| Olfactory bulb volume | Baseline,Month 3,Month 6,Month 12,Month 24 | Measurement of the olfactory bulb volume using MRI to assess changes or improvements in olfactory structures which might correlate with training efficacy. |
| Neuropsychiatric Inventory (NPI) | Baseline,Month 3,Month 6,Month 12,Month 24 | Measures behavioral changes including depression, anxiety, aggression, and apathy among others, providing a comprehensive overview of psychological status. |
| Digit Span Test (DST) | Baseline,Month 3,Month 6,Month 12,Month 24 | Assesses attention and working memory through forward and backward number recall tasks. |
| Trail Making Test (TMT) | Baseline,Month 3,Month 6,Month 12,Month 24 | 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) | Baseline,Month 3,Month 6,Month 12,Month 24 | Used to assess visual-spatial abilities and executive function by having participants draw a clock showing a specific time. |
Countries
China
Contacts
Primary ContactDawei Wu
Outcome results
None listed