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

NCT06902181 | Recruiting

• 1 other identifier: CMUH113-REC1-180
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mild Cognitive Impairment

Keywords

mild cognitive impairment; aromatherapy; essential oil,; neuroinflammation; neuroprotection; olfactory training

Outcome Measures

Primary Outcomes (1)

• Contextual Memory Test (CMT)

  The Contextual Memory Test (CMT) is a standardized cognitive assessment used to evaluate memory function in individuals with mild cognitive impairment (MCI). The test measures both immediate and delayed recall of visual stimuli in a structured context. At each study visit, participants will complete both immediate and delayed recall tasks. Each section is scored out of 20 points, resulting in a total raw score ranging from 0 to 40. Higher scores indicate better memory performance. This assessment provides a quantitative and repeatable measure of episodic memory, allowing for longitudinal tracking of cognitive changes throughout the study.

  Baseline (V1), Post-Intervention (Day 28) (V2), and Follow-up (Day 56) (V3).

Secondary Outcomes (10)

• Montreal Cognitive Assessment(MoCA)

  Baseline (V1), Post-Intervention (Day 28) (V2), and Follow-up (Day 56) (V3).

• Taiwan Odd-Even Number Sequencing Test (TOENST)

  Baseline (V1), Post-Intervention (Day 28) (V2), and Follow-up (Day 56) (V3).

• Beck Depression Inventory (BDI)

  Baseline (V1), Post-Intervention (Day 28) (V2), and Follow-up (Day 56) (V3).

• Beck Anxiety Inventory (BAI)

  Baseline (V1), Post-Intervention (Day 28) (V2), and Follow-up (Day 56) (V3).

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline (V1), Post-Intervention (Day 28) (V2), and Follow-up (Day 56) (V3).

Study Arms (2)

Experimental Group - 100% CXMCI-01 Essential Oil

EXPERIMENTAL

Experimental Group - 100% CXMCI-01 Essential Oil. Used by inhalation in the morning and night.

Behavioral: Experimental Group - 100% CXMCI-01 Essential Oil

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

PLACEBO COMPARATOR

Control Group - 0.1% CXMCI-01 Essential Oil (Placebo). Used by inhalation in the morning and night.

Behavioral: Control Group - 0.1% CXMCI-01 Essential Oil (placebo)

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.

Experimental Group - 100% CXMCI-01 Essential Oil

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.

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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Neurological consultation: Participants must undergo a neurology consultation, including medical history review, neurological examination, and olfactory function testing.
• No essential oil use within the past month.

You may not qualify if:

• Dementia caused by other conditions, including: Alzheimer's disease, Parkinson's disease, vascular dementia, traumatic brain injury, central nervous system infections or multiple sclerosis
• Cognitive impairment due to brain lesions, such as: brain tumors, hydrocephalus, severe brain atrophy
• Severe metabolic disorders potentially affecting cognitive function, including:
• Uncontrolled hyperthyroidism or hypothyroidism
• Uncorrected electrolyte imbalance
• Liver dysfunction (ALT or AST \> 1.5× normal upper limit)
• Renal dysfunction (Creatinine \> 1.5× normal upper limit)
• Uncontrolled or poorly managed diabetes (Random glucose \> 200 mg/dL and HbA1c \> 8%)
• Uncontrolled or poorly managed hypertension (SBP \> 160 mmHg or DBP \> 100 mmHg)
• Uncorrected vitamin B12 or folate deficiency
• Severe anemia (Hb \< 8 g/dL) or acute bleeding causing Hb \< 8 g/dL
• Current severe infection (fever \> 38°C, ongoing antibiotic use, or abnormal WBC count)
• Body Mass Index (BMI) ≥ 35
• Severe nasal or pharyngeal diseases affecting olfactory function, or history of asthma attacks in the past six months.
• Substance or alcohol abuse within the past two years, meeting DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) criteria.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (2)

Everan Hospital

Taichung, 411001, Taiwan

RECRUITING

Everan Hospital

Taichung, 411, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Neuroinflammatory Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yu-Huei Liu, NTU, Ph.D. (Biochem & Mol Bio)

  Graduate Institute of Integrated Medicine, China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu-Huei Liu, NTU, Ph.D. (Biochem & Mol Bio)

CONTACT

+886-4-22052121 #12044; yuhueiliu@mail.cmu.edu.tw

Hui-Hsuan Chen, M.D.

CONTACT

+886 981 427898; chsphilo@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2025
• First Posted: March 30, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)