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

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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.

Первичные конечные точки

• Change in Clinical Rating Scale for Tremor (CRST) total score from baseline to 3 months [Срок оценки: Baseline and 3 months]
• Change in Activities of Daily Living (ADL) score from baseline to 3 months [Срок оценки: Baseline and 3 months]

Вторичные конечные точки (4)

• Change in 24-hour Urinary Catecholamine Levels (epinephrine, norepinephrine, dopamine) [Срок оценки: Baseline and 3 months]
• Change in Random Urinary Malondialdehyde [Срок оценки: Baseline and 3 months]
• Change in Serum C-Reactive Protein (CRP) Level [Срок оценки: Baseline and 3 months]
• Incidence of adverse events during the intervention period [Срок оценки: Through study completion (up to 3 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Korea University Anam Hospital — Seoul

Публикации

• 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

Идентификаторы

NCT: NCT07238725 · 2024AN0506

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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