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.

Conditions

• Mild Cognitive Impairment

Interventions

BEHAVIORAL

Experimental Group - 100% CXMCI-01 Essential Oil

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.

BEHAVIORAL

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

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.

Sponsors & Collaborators

• China Medical University Hospital

  lead OTHER

Principal Investigators

• Yu-Huei Liu, NTU, Ph.D. (Biochem & Mol Bio) · Graduate Institute of Integrated Medicine, China Medical University

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-07

Primary Completion

2027-02-28

Completion

2027-02-28

Countries

• Taiwan

Study Locations