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

Launched by CHINA MEDICAL UNIVERSITY HOSPITAL · Mar 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of inhaling a special essential oil called CXMCI-01 on patients with Mild Cognitive Impairment (MCI), a condition where people experience memory and thinking problems that are not severe enough to be classified as dementia. The aim of the trial is to see if this essential oil can help improve memory, sleep, mood, and overall quality of life for those with MCI. The study will involve 100 participants who are diagnosed with MCI by a neurologist and will be divided into two groups—one group will inhale a higher concentration of the essential oil, while the other group will inhale a much lower concentration. Participants will take part in the study for 28 days and will undergo several assessments to measure changes in their cognitive abilities and quality of life.

To be eligible for the trial, participants need to be 50 years or older and must have been diagnosed with MCI. They should not have any other major neurological conditions or severe health issues that could affect their cognitive function. Participants will need to attend a few visits during the trial to complete memory tests and other evaluations. It’s important to note that individuals who have recently used essential oils or have certain medical conditions may not be able to join the study. This trial could provide valuable insights into new, non-drug treatments for patients with MCI.

Gender

ALL

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.