The Efficacy of Modified Olfactory Training for MCI High-Risk Individuals

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorPeking University Third Hospital

About this trial

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?

Eligibility criteria

Qualifiers

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.

Disqualifiers

Comorbid Chronic Diseases or Severe Concurrent Illnesses: Individuals with conditions such as hypertension, diabetes, bronchopneumonia, malignant tumors, or chronic obstructive pulmonary disease.

Trial design

Treatments tested in this trial

  • Modified olfactory training device
  • Conventional olfactory training device

Treatment groups

114 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Peking University Third Hospital

Lead sponsor

Peking University Sixth Hospital

Collaborator