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

NCT06821828 | Not Yet Recruiting DMC

• 1 other identifier: 9059101
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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?

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

Outcome Measures

Primary Outcomes (4)

• Montreal Cognitive Assessment (MoCA) score

  The MoCA score will be used to evaluate cognitive function across several domains including memory, attention, language, and orientation.

  Baseline,Month 3,Month 6,Month 12,Month 24

• Biomarkers of cognition (Blood/CSF)

  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.

  Baseline,Month 3,Month 6,Month 12,Month 24

• Neuroimaging assessments

  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.

  Baseline,Month 3,Month 6,Month 12,Month 24

• The Sniffin' Sticks test

  a clinically significant olfactory improvement as measured by Sniffin' Sticks threshold, discrimination, and identification（TDI)( more than 6 scores)

  Baseline,Month 3,Month 6,Month 12,Month 24

Secondary Outcomes (12)

• Auditory Verbal Learning Test (AVLT)

  Baseline,Month 3,Month 6,Month 12,Month 24

• Digit Span Test (DST)

  Baseline,Month 3,Month 6,Month 12,Month 24

• Trail Making Test (TMT)

  Baseline,Month 3,Month 6,Month 12,Month 24

• Clock Drawing Test (CDT)

  Baseline,Month 3,Month 6,Month 12,Month 24

• Boston Naming Test (BNT)

  Baseline,Month 3,Month 6,Month 12,Month 24

Study Arms (3)

the Modified Olfactory Training Group

EXPERIMENTAL

Participants will use a modified olfactory training device based on expiratory pressure. Four odors will be used: rose, mint, lemon, and clove. Each odorant is sniffed for 10 seconds per session, with a 10-second interval between odors. Each training session lasts 5 minutes and is conducted twice daily, before breakfast and at bedtime, for a duration of two years.

Combination Product: Modified olfactory training device

the Conventional Training Group

ACTIVE COMPARATOR

Patients will receive the conventional olfactory training device. Patients had to sniff one odor for approximately 10 seconds and turn to another after a rest of 10 seconds. Each training session lasts 5 minutes and is conducted twice daily, before breakfast and at bedtime, for a duration of two years.

Combination Product: Conventional olfactory training device

the Control Group

NO INTERVENTION

Participants will not receive any olfactory training and will be advised to observe and wait for spontaneous recovery of olfactory function.

Interventions

Modified olfactory training device COMBINATION_PRODUCT

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.

the Modified Olfactory Training Group

Conventional olfactory training device COMBINATION_PRODUCT

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.

the Conventional Training Group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Peking University Sixth Hospital: collaborator

Study Sites (1)

Dawei Wu

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

• Lin CY, Tan Y, Zhao D, Wu D. Assessing modified olfactory training to prevent cognitive decline in MCI high-risk individuals: a multicentre randomised controlled trial protocol in Beijing tertiary hospitals. BMJ Open. 2025 Aug 13;15(8):e100880. doi: 10.1136/bmjopen-2025-100880.

  PMID: 40812823 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Dawei Wu

CONTACT

13522503401; davidwuorl@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Researcher

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: February 12, 2025
• Study Start: March 22, 2025
• Primary Completion (Estimated): March 22, 2027
• Study Completion (Estimated): May 22, 2027
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)