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

Pico Entech Co., Ltd.

Status: Invitation-only

Conditions: Essential Tremor

Treatments: Dietary Supplement: PICOZYME ET

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07238725

2024AN0506

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

ALDH Food Supplement

Experimental group

Description:

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.

Treatment:

Dietary Supplement: PICOZYME ET