The Efficacy of Aldehyde Dehydrogenase Enzyme in Essential Tremor Patients: A Single-Center Study

This is a sponsor-initiated, single-arm, single-center clinical trial designed to evaluate the efficacy and safety of an ALDH-containing food supplement (PICOZYME ET) in patients with Essential Tremor (ET). Participants will consume the investigational product daily for three months, and clinical outcomes will be assessed using the Clinical Rating Scale for Tremor (CRST) and the Activities of Daily Living (ADL) scale. Additional exploratory analyses will evaluate changes in metabolic biomarkers and brain function via imaging and blood tests.

Study Overview

• Status: Enrolling by invitation
• Conditions: Essential Tremor
• Intervention / Treatment: Dietary supplement: PICOZYME ET

Detailed Description

Essential Tremor (ET) is one of the most common adult movement disorders, characterized by involuntary rhythmic tremors, primarily affecting the hands. Although not life-threatening, ET significantly impacts quality of life and daily functioning. Recent studies suggest that oxidative stress and impaired GABAergic inhibition may be involved in its pathophysiology, and aldehyde dehydrogenase (ALDH) is believed to play a role in mitigating these mechanisms.

This single-center, open-label, sponsor-initiated study is funded by PICO Entech Corp and conducted at Korea University Anam Hospital under the supervision of the institutional IRB. The trial aims to evaluate the efficacy and safety of an ALDH-containing food supplement (PICOZYME ET) in patients with ET. A total of 40 adult participants diagnosed with ET will be enrolled and instructed to consume the investigational food product twice daily for three months. Efficacy will be measured by changes from baseline in the Clinical Rating Scale for Tremor (CRST) and Activities of Daily Living (ADL) scores.

Secondary outcomes include safety and biomarker analysis through blood tests. Exploratory outcomes include changes in metabolic activity via FDG PET-CT imaging, levels of oxidative stress biomarkers (malondialdehyde, total aldehyde), and potential associations with GABA-related metabolic pathways.

The study has received IRB approval from Korea University Anam Hospital and includes oversight from a Data Safety Monitoring Board (DSMB). All participants will provide written informed consent before enrollment.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea, 02841
    • Korea University Anam Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged ≥ 19 years who provide written informed consent.
• Diagnosed with Essential Tremor (ET) by a board-certified neurologist or neurosurgeon.
• Presence of postural or intention tremor in the dominant hand/arm with a CRST score ≥ 2.
• Stable medication regimen for at least 30 days prior to enrollment.
• No structural brain abnormalities on MRI within the last 3 years.
• Eligible according to investigator assessment and agreement by two clinical team members.

Exclusion Criteria:

• Presence of secondary tremor causes (e.g., Parkinsonism, dystonia).
• Significant medical conditions such as severe arrhythmia, renal failure, hepatic failure, acute stroke, or epilepsy.
• Contraindications to MRI (e.g., pacemakers, metal implants).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALDH Food Supplement; Participants in this arm will receive an ALDH-containing food supplement (PICOZYME ET) twice daily for 3 months. The study will assess changes in tremor severity, quality of life, and exploratory metabolic biomarkers.	Dietary supplement: PICOZYME ET; The investigational product is a dietary supplement containing aldehyde dehydrogenase (ALDH), administered orally twice daily (one packet in the morning and one in the evening) for 3 months before meals.; Other Names: ALDH food supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Rating Scale for Tremor (CRST) total score from baseline to 3 months	The CRST is a validated clinical tool used to quantify tremor severity. It includes assessments of postural, action, and intention tremor, as well as functional disability. Total scores range from 0 to 160, with higher scores indicating more severe tremor.	Baseline and 3 months
Change in Activities of Daily Living (ADL) score from baseline to 3 months	ADL will be assessed using the QUEST (Quality of Life in Essential Tremor) questionnaire. Higher scores indicate greater functional impairment.	Baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events during the intervention period	Adverse events (e.g., nausea, gastrointestinal discomfort) will be monitored and recorded throughout the 3-month supplementation period to assess safety.	Through study completion (up to 3 months)
Change in 24-hour Urinary Catecholamine Levels (epinephrine, norepinephrine, dopamine)	Measurement of 24-hour urinary catecholamine levels (epinephrine, norepinephrine, dopamine) in µg/day at baseline and 3 months to evaluate oxidative stress.	Baseline and 3 months
Change in Random Urinary Malondialdehyde	Semi-quantitative measurement of malondialdehyde in random urine using dipstick analysis (DFI FRC 50SF analyzer and Free RadiCheck test strips), with results reported as relative values.	Baseline and 3 months
Change in Serum C-Reactive Protein (CRP) Level	Measurement of serum CRP concentration in mg/L at baseline and 3 months.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Pico Entech Co., Ltd.
• Collaborators: Korea University Anam Hospital

Publications and helpful links

General Publications

• Louis ED, Ferreira JJ. How common is the most common adult movement disorder? Update on the worldwide prevalence of essential tremor. Mov Disord. 2010 Apr 15;25(5):534-41. doi: 10.1002/mds.22838.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: October 23, 2025
• First Submitted That Met QC Criteria: November 18, 2025
• First Posted (Actual): November 20, 2025

Study Record Updates

• Last Update Posted (Actual): November 20, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Oxidative Stress; Essential Tremor; Tremor; Antioxidant; Aldehyde Dehydrogenase; ALDH
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Dyskinesias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tremor; Essential Tremor
• Other Study ID Numbers: 2024AN0506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared. This study involves a small, single-site intervention, and data sharing is not planned due to institutional policy and privacy considerations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No