NCT07238725

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Pico Entech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Essential Tremor

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-03-10
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2025-11-20
• Last updated: 2025-11-20

Locations

1 site across 1 country: South Korea