Essential Tremor
Conditions
Keywords
Essential Tremor, Tremor, ALDH, Aldehyde Dehydrogenase, Oxidative Stress, Antioxidant
Brief 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.
Interventions
DIETARY_SUPPLEMENTPICOZYME 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.
Sponsors
Korea University Anam Hospital
Pico Entech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open-label study
Intervention model description
Single-arm, open-label trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Rating Scale for Tremor (CRST) total score from baseline to 3 months | 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 | Baseline and 3 months | ADL will be assessed using the QUEST (Quality of Life in Essential Tremor) questionnaire. Higher scores indicate greater functional impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour Urinary Catecholamine Levels (epinephrine, norepinephrine, dopamine) | Baseline and 3 months | Measurement of 24-hour urinary catecholamine levels (epinephrine, norepinephrine, dopamine) in µg/day at baseline and 3 months to evaluate oxidative stress. |
| Change in Random Urinary Malondialdehyde | Baseline and 3 months | Semi-quantitative measurement of malondialdehyde in random urine using dipstick analysis (DFI FRC 50SF analyzer and Free RadiCheck test strips), with results reported as relative values. |
| Change in Serum C-Reactive Protein (CRP) Level | Baseline and 3 months | Measurement of serum CRP concentration in mg/L at baseline and 3 months. |
| Incidence of adverse events during the intervention period | Through study completion (up to 3 months) | Adverse events (e.g., nausea, gastrointestinal discomfort) will be monitored and recorded throughout the 3-month supplementation period to assess safety. |
Countries
South Korea
Outcome results
None listed