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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Everan Hospital
RECRUITING
Taichung
Everan Hospital
NOT_YET_RECRUITING
Taichung
Contact Information
Primary
Yu-Huei Liu, NTU, Ph.D. (Biochem & Mol Bio)
yuhueiliu@mail.cmu.edu.tw
+886-4-22052121 #12044
Backup
Hui-Hsuan Chen, M.D.
chsphilo@gmail.com
+886 981 427898
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2027-02
Participants
Target number of participants: 100
Treatments
Experimental: Experimental Group - 100% CXMCI-01 Essential Oil
Experimental Group - 100% CXMCI-01 Essential Oil. Used by inhalation in the morning and night.
Placebo_comparator: Control Group - 0.1% CXMCI-01 Essential Oil (placebo)
Control Group - 0.1% CXMCI-01 Essential Oil (Placebo). Used by inhalation in the morning and night.
Related Therapeutic Areas
Sponsors
Leads: China Medical University Hospital

This content was sourced from clinicaltrials.gov

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