Essential TremorNCT07238725
The Efficacy of Aldehyde Dehydrogenase Enzyme in Essential Tremor Patients: A Single-Center Study
A study testing PICOZYME ET in people with Essential Tremor, run by Pico Entech Co., Ltd. at 1 site in South Korea.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Tremor
- What is being tested?
- PICOZYME ET
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 Mar 2025to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Essential Tremor
- Being tested
- PICOZYME ET
- Keywords
- Essential Tremor, Tremor, ALDH, Aldehyde Dehydrogenase, Oxidative Stress, Antioxidant
- Medical subject headings
- Essential Tremor, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PICOZYME ETDietary supplement
Also called ALDH food supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| ALDH Food Supplement | Experimental | 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. Receives: Dietary Supplement: PICOZYME ET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinical Rating Scale for Tremor (CRST) total score from baseline to 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.
Measured: Baseline and 3 months
Change in Activities of Daily Living (ADL) score from baseline to 3 months
ADL will be assessed using the QUEST (Quality of Life in Essential Tremor) questionnaire. Higher scores indicate greater functional impairment.
Measured: Baseline and 3 months
Secondary outcomes (4)
Change in 24-hour Urinary Catecholamine Levels (epinephrine, norepinephrine, dopamine)
Measurement of 24-hour urinary catecholamine levels (epinephrine, norepinephrine, dopamine) in µg/day at baseline and 3 months to evaluate oxidative stress.
Measured: Baseline and 3 months
Change in Random Urinary Malondialdehyde
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.
Measured: Baseline and 3 months
Change in Serum C-Reactive Protein (CRP) Level
Measurement of serum CRP concentration in mg/L at baseline and 3 months.
Measured: Baseline and 3 months
Incidence of adverse events during the intervention period
Adverse events (e.g., nausea, gastrointestinal discomfort) will be monitored and recorded throughout the 3-month supplementation period to assess safety.
Measured: Through study completion (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start10 Mar 2025
- Primary completion8 Jan 2026
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential TremorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, open-label trial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pico Entech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Korea University Anam Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07238725
- Sponsor's protocol ID
- 2024AN0506
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared. This study involves a small, single-site intervention, and data sharing is not planned due to institutional policy and privacy considerations.
Publications
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.
PubMed 20175185
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Aldehyde Dehydrogenase Enzyme in Essential Tremor Patients: A Single-Center Study
- ClinicalTrials.gov ID
- NCT07238725
- Acronym / sponsor ID
- 2024AN0506
- Conditions
- Essential Tremor
- Keywords
- Essential Tremor, Tremor, ALDH, Aldehyde Dehydrogenase, Oxidative Stress, Antioxidant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Pico Entech Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Korea University Anam Hospital
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 8 Jan 2026 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 20 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, open-label trial
| Arm | Type | Receives |
|---|---|---|
| ALDH Food Supplement | Experimental | Dietary Supplement: PICOZYME ETParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PICOZYME ETAlso: ALDH food supplementThe 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. | Dietary supplement | ALDH Food Supplement |
Primary outcome
Change in Clinical Rating Scale for Tremor (CRST) total score from baseline to 3 months
Time frame: 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
Time frame: Baseline and 3 months
ADL will be assessed using the QUEST (Quality of Life in Essential Tremor) questionnaire. Higher scores indicate greater functional impairment.
4 secondary outcomes
Change in 24-hour Urinary Catecholamine Levels (epinephrine, norepinephrine, dopamine)
Time frame: Baseline and 3 months
Change in Random Urinary Malondialdehyde
Time frame: Baseline and 3 months
Change in Serum C-Reactive Protein (CRP) Level
Time frame: Baseline and 3 months
Incidence of adverse events during the intervention period
Time frame: Through study completion (up to 3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Results publication: PubMed 20175185Louis 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared. This study involves a small, single-site intervention, and data sharing is not planned due to institutional policy and privacy considerations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PICOZYME ET in people with Essential Tremor, run by Pico Entech Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical Rating Scale for Tremor (CRST) total score from baseline to 3 months (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07238725, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.