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

Summary

Memory declined and cognitive impairment are common complaints in neurology clinics. Before diagnosing as dementia, individuals will undergo a transition period, including mild cognitive impairment (MCI). Neuroinflammation is an important mechanism of memory problems. For patients with MCI, there are limited available medications. Currently, there is no standardized treatment in Taiwan. The purpose of this study is to explore alternative treatment with essential oil by inhalation to improve memory, sleep, mood, and quality of life for patients with MCI. This study will include patients who are clinically diagnosed as MCI by a neurologist. This is a double-blind randomized controlled trial, which will include 100 participants with 1:1 allocation into the intervention group and control group. The experimental group will receive 100% CXMCI-01-M Essential Oil every morning and 100% CXMCI-01-N Essential Oil by inhalation every night. The control group will receive 0.1% CXMCI-01-M Essential Oil every morning and 0.1% CXMCI-01-N Essential Oil by inhalation every night. The intervention method involves inhaling for 5 minutes, followed by wearing an essential oil necklace for 60 minutes. Examinations will be conducted before intervention (first visit, V1) and 28 days later (second visit, V2). After 28 days of finishing intervention, the third visit (V3) will be conducted. The primary outcome is the Contextual Memory Test (CMT). Secondary outcomes are Montreal Cognitive Assessment (MoCA), Taiwan Odd-Even Number Sequencing Test (TOENST), Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), Pittsburgh Sleep Quality Index (PSQI), and 36-Item Short Form Health Survey (SF-36). Serum biomarkers of amyloid, tau protein, and metabolomics will be checked, as well as urine biomarkers related to neuroinflammation, including lipid peroxidation (LPO), 8-hydroxy-2-deoxyguanosine (8-OHdG), kynurenine, picolinate, quinolinate, and kynurenate. Changes in meridian energy will also be examined by M.E.A.D. and HRV before and after the intervention. It is expected that this study will contribute to the clinical application of CXMCI-01 Essential Oil in patients with MCI and improve their memory, mood, and sleep quality.

Interventions

• Experimental Group - 100% CXMCI-01 Essential Oil · BEHAVIORAL

  Participants in the experimental group will inhale 100% CXMCI-01 essential oil twice(CXMCI-01-M in morning, CXMCI-01-N in night) daily for 28 days using an aroma necklace. Each session involves placing 2 drops of the essential oil on a cotton pad inside the necklace. Inhale near the nose for 5 minutes, then wear the aroma necklace and continue inhalation for 60 minutes.

• Control Group - 0.1% CXMCI-01 Essential Oil (placebo) · BEHAVIORAL

  Participants in the placebo group will inhale a 0.1% CXMCI-01 essential oil dilution twice (CXMCI-01-M in morning, CXMCI-01-N in night) ) daily for 28 days. The protocol mirrors the experimental group: inhalation near the nose for 5 minutes, followed by wearing an aroma necklace infused with the diluted essential oil for 60 minutes. This group serves as a placebo comparator to evaluate the effectiveness of the experimental intervention.

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (2)

• Everan Hospital, Taichung, Taiwan · RECRUITING
• Everan Hospital, Taichung, Taiwan · NOT_YET_RECRUITING