The Efficacy of Aldehyde Dehydrogenase Enzyme in Essential Tremor Patients: A Single-Center Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Clinical Rating Scale for Tremor (CRST) total score from baseline to 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open-label study
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 ≥
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Clinical Rating Scale for Tremor (CRST) total score from baseline to 3 months
时间窗: Baseline and 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.
Change in Activities of Daily Living (ADL) score from baseline to 3 months
时间窗: Baseline and 3 months
ADL will be assessed using the QUEST (Quality of Life in Essential Tremor) questionnaire. Higher scores indicate greater functional impairment.
次要结局
- 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))