Clinical trial NCT06821828: The Efficacy of Modified Olfactory Training for MCI High-Risk Individuals
Official title: Assessing Modified Olfactory Training to Prevent Cognitive Decline in MCI High-Risk Individuals: A Randomized Controlled Trial Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Subjective Cognitive Decline (SCD)
Olfactory Dysfunction
Mild Cognitive Impairment (MCI)
ELDERLY PEOPLE
Keywords: Mild Cognitive Impairment (MCI)
Subjective Cognitive Decline (SCD)
olfactory training
elderly population
Olfactory Dysfunction
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Peking University Sixth Hospital
First posted: 2025-02-12
Enrollment: 114
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 outcomes:
measure: Montreal Cognitive Assessment (MoCA) score
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Biomarkers of cognition (Blood/CSF)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Neuroimaging assessments
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: The Sniffin' Sticks test
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
Secondary outcomes:
measure: Auditory Verbal Learning Test (AVLT)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Digit Span Test (DST)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Trail Making Test (TMT)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Clock Drawing Test (CDT)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Boston Naming Test (BNT)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Verbal Fluency Test (VFT)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Activities of Daily Living Scale (ADL)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Instrumental Activities of Daily Living (IADL)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Hamilton Anxiety Scale (HAMA)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Hamilton Depression Scale (HAMD)
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
measure: Olfactory bulb volume
timeFrame: Baseline,Month 3,Month 6,Month 12,Month 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dawei Wu
state: Beijing
Study officials:
References: