Subjective Cognitive Decline (SCD)NCT06821828
The Efficacy of Modified Olfactory Training for MCI High-Risk Individuals
A study testing Modified olfactory training device and Conventional olfactory training device in people with Subjective Cognitive Decline (SCD) and Olfactory Dysfunction, run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Subjective Cognitive Decline (SCD), Olfactory Dysfunction, Mild Cognitive Impairment (MCI)
- What is being tested?
- Modified olfactory training device and Conventional olfactory training device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2025to 22 May 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Dawei Wu
Beijing, Beijing Municipality, 100191
Dawei Wu, MD, PhD, +86 13522503401, davidwuorl@163.com
Dawei Wu, MD, PhD
About this study
Official title: Assessing Modified Olfactory Training to Prevent Cognitive Decline in MCI High-Risk Individuals: A Randomized Controlled Trial Protocol
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?
Read the 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.
- Conditions
- Subjective Cognitive Decline (SCD), Olfactory Dysfunction, Mild Cognitive Impairment (MCI), ELDERLY PEOPLE
- Being tested
- Modified olfactory training device, Conventional olfactory training device
- Keywords
- Mild Cognitive Impairment (MCI), Subjective Cognitive Decline (SCD), olfactory training, elderly population, Olfactory Dysfunction
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified olfactory training deviceCombination 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.
Conventional olfactory training deviceCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA) score
The MoCA score will be used to evaluate cognitive function across several domains including memory, attention, language, and orientation.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Secondary outcomes (12)
Auditory Verbal Learning Test (AVLT)
Evaluates immediate memory recall, learning rate, and delayed recall, providing insights into verbal learning and memory.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Digit Span Test (DST)
Assesses attention and working memory through forward and backward number recall tasks.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Trail Making Test (TMT)
Measures visual attention and task switching by requiring participants to connect a sequence of numbers and letters as quickly as possible.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Clock Drawing Test (CDT)
Used to assess visual-spatial abilities and executive function by having participants draw a clock showing a specific time.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Boston Naming Test (BNT)
Measures language function, specifically object naming ability, which is crucial for everyday communication.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Verbal Fluency Test (VFT)
Assesses cognitive flexibility and semantic memory by requiring participants to generate as many words as possible from a category in a limited time.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Activities of Daily Living Scale (ADL)
Evaluates the participant's ability to perform everyday tasks independently, reflecting functional status.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Instrumental Activities of Daily Living (IADL)
Assesses more complex daily living skills critical for independent living, such as managing finances and medication.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Neuropsychiatric Inventory (NPI)
Measures behavioral changes including depression, anxiety, aggression, and apathy among others, providing a comprehensive overview of psychological status.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Hamilton Anxiety Scale (HAMA)
Assesses the severity of anxiety symptoms, which can impact cognitive and daily functioning.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Hamilton Depression Scale (HAMD)
Used to quantify the level of depressive symptoms, aiding in the assessment of mood disorders which can co-occur with cognitive decline.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Olfactory bulb volume
Measurement of the olfactory bulb volume using MRI to assess changes or improvements in olfactory structures which might correlate with training efficacy.
Measured: Baseline,Month 3,Month 6,Month 12,Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start22 Mar 2025 (estimated)
- Primary completion22 Mar 2027 (estimated)
- Study completion22 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subjective Cognitive Decline (SCD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Sixth Hospital
- Responsible party
- Principal investigator, Dawei Wu, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06821828
- Sponsor's protocol ID
- 9059101
- Status last verified
- Feb 2025
- First submitted
- 6 Feb 2025
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will decide whether to share the individual participant data after the study.
Publications
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.
PubMed 40812823