Inhalation of essential oil for patients with mild cognitive impairment

Observation of Inhalation of CXMCI-01 Essential Oil on Patients With Mild Cognitive Impairment

This study is testing if inhaling a special essential oil can help people with mild cognitive impairment improve their memory, mood, sleep, and overall quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: China Medical University Hospital (Academic / other)
• Locations: 2 sites (Taichung and 1 other locations)
• Trial ID: NCT06902181 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effects of inhaling CXMCI-01 essential oil on patients diagnosed with mild cognitive impairment (MCI). It is a double-blind randomized controlled trial involving 100 participants who will be divided into two groups: one receiving 100% essential oil and the other receiving a placebo. The study aims to assess improvements in memory, sleep, mood, and overall quality of life by targeting neuroinflammation, a key factor in cognitive decline. Participants will undergo thorough neurological assessments to confirm their eligibility.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 50 and older who have been clinically diagnosed with mild cognitive impairment and meet specific cognitive assessment criteria.

Not a fit: Patients with dementia caused by other neurological conditions or those with severe cognitive impairment due to brain lesions will not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel, non-pharmacological treatment option to improve cognitive function and quality of life for patients with MCI.

How similar studies have performed: While the use of essential oils in cognitive impairment is relatively novel, some studies have shown promising results in related areas, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Aged 50 years or older, presenting with memory and cognitive impairment. Diagnosed with Mild Cognitive Impairment (MCI) by a neurologist based on clinical and psychological assessment. Mini-mental state examination(MMSE) ≥ 23 and Clinical Dementia Rating (CDR) = 0.5.
2. Neurological consultation: Participants must undergo a neurology consultation, including medical history review, neurological examination, and olfactory function testing.
3. No essential oil use within the past month.

Exclusion Criteria:

1. Dementia caused by other conditions, including: Alzheimer's disease, Parkinson's disease, vascular dementia, traumatic brain injury, central nervous system infections or multiple sclerosis
2. Cognitive impairment due to brain lesions, such as: brain tumors, hydrocephalus, severe brain atrophy
3. Severe metabolic disorders potentially affecting cognitive function, including:

   1. Uncontrolled hyperthyroidism or hypothyroidism
   2. Uncorrected electrolyte imbalance
   3. Liver dysfunction (ALT or AST \> 1.5× normal upper limit)
   4. Renal dysfunction (Creatinine \> 1.5× normal upper limit)
   5. Uncontrolled or poorly managed diabetes (Random glucose \> 200 mg/dL and HbA1c \> 8%)
   6. Uncontrolled or poorly managed hypertension (SBP \> 160 mmHg or DBP \> 100 mmHg)
   7. Uncorrected vitamin B12 or folate deficiency
   8. Severe anemia (Hb \< 8 g/dL) or acute bleeding causing Hb \< 8 g/dL
   9. Current severe infection (fever \> 38°C, ongoing antibiotic use, or abnormal WBC count)
   10. Body Mass Index (BMI) ≥ 35
4. Severe nasal or pharyngeal diseases affecting olfactory function, or history of asthma attacks in the past six months.
5. Substance or alcohol abuse within the past two years, meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) criteria.
6. Diagnosis of psychiatric disorders within the past year, including: Major depressive disorder, schizophrenia, bipolar disorder (DSM-5 criteria),
7. Severe insomnia, defined as:

(1) Experiencing insomnia symptoms for more than 50% of days per month for at least three months, causing daytime fatigue.

(2) Use of three or more sleep-related medications (e.g., benzodiazepines or Z-drugs).

8\. History of cancer under active treatment. 9. Use of anticholinergic or acetylcholinesterase inhibitor medications. 10.Concurrent use of other neuroprotective therapies, including traditional Chinese medicine or dietary supplements (except for long-term users exceeding three months).

11.Allergy to essential oils. 12.Inability to comply with essential oil inhalation procedures. 13.Other conditions deemed inappropriate by the principal investigator. 14.Inability to understand or comply with study procedures, or failure to sign the informed consent form.

Where this trial is running

Taichung and 1 other locations

• Everan Hospital — Taichung, Taiwan (Recruiting)
• Everan Hospital — Taichung, Taiwan (Not_yet_recruiting)

Study contacts

• Principal investigator: Yu-Huei Liu, NTU, Ph.D. (Biochem & Mol Bio) — Graduate Institute of Integrated Medicine, China Medical University
• Study coordinator: Yu-Huei Liu, NTU, Ph.D. (Biochem & Mol Bio)

Conditions Mild Cognitive Impairment; mild cognitive impairment; aromatherapy; essential oil,; neuroinflammation; neuroprotection; olfactory training