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

NCT07238725 | Enrolling By Invitation DMC

• 1 other identifier: 2024AN0506
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Essential Tremor

Keywords

Essential Tremor; Tremor; ALDH; Aldehyde Dehydrogenase; Oxidative Stress; Antioxidant

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change in 24-hour Urinary Catecholamine Levels (epinephrine, norepinephrine, dopamine)

  Baseline and 3 months

• Change in Random Urinary Malondialdehyde

  Baseline and 3 months

• Change in Serum C-Reactive Protein (CRP) Level

  Baseline and 3 months

• Incidence of adverse events during the intervention period

  Through study completion (up to 3 months)

Study Arms (1)

ALDH Food Supplement

EXPERIMENTAL

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

Interventions

PICOZYME ET DIETARY_SUPPLEMENT

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.

Also known as: ALDH food supplement

ALDH Food Supplement

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pico Entech Co., Ltd.: lead
• Korea University Anam Hospital: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Related Publications (1)

• 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.

  PMID: 20175185 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Essential Tremor; Tremor

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label study
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, open-label trial

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: November 20, 2025
• Study Start: March 10, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)