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Completed NCT07238725

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

Conditions: Essential Tremor

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 31
Sponsor: Pico Entech Co., Ltd.

Location: Korea University Anam Hospital Seoul

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.

Eligibility Criteria

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).

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07238725). StuddyBuddy aggregates publicly available trial information.