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

China114 participantsStarted 2025-03-22

Plain-language 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?

Who can participate

Age range60 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

Montreal Cognitive Assessment (MoCA) score

Timeframe: Baseline,Month 3,Month 6,Month 12,Month 24

Biomarkers of cognition (Blood/CSF)

Timeframe: Baseline,Month 3,Month 6,Month 12,Month 24

Neuroimaging assessments

Timeframe: Baseline,Month 3,Month 6,Month 12,Month 24

The Sniffin' Sticks test

Timeframe: Baseline,Month 3,Month 6,Month 12,Month 24

Trial details

NCT IDNCT06821828

SponsorPeking University Third Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-22

Contact for this trial

Dawei Wu

13522503401 davidwuorl@163.com

View on ClinicalTrials.gov More Subjective Cognitive Decline (SCD) trials

Plain-language summary

Who can participate

Age range60 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion criteria

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

What they're measuring

Montreal Cognitive Assessment (MoCA) score

Timeframe: Baseline,Month 3,Month 6,Month 12,Month 24

Biomarkers of cognition (Blood/CSF)

Timeframe: Baseline,Month 3,Month 6,Month 12,Month 24

Neuroimaging assessments

Timeframe: Baseline,Month 3,Month 6,Month 12,Month 24

The Sniffin' Sticks test

Timeframe: Baseline,Month 3,Month 6,Month 12,Month 24