NCT06821828 · NOT YET RECRUITING
The Efficacy of Modified Olfactory Training for MCI High-Risk Individuals
This trial is testing whether a modified smell-training device can slow cognitive decline in older adults who already show early warning signs: mild olfactory loss and subjective memory concerns. Participants use the device to practice identifying scents, and researchers compare it to a standard smell-training device. This is a Phase NA trial, meaning it is likely a device feasibility or efficacy study rather than a traditional drug phase.
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-02-12