Spinocerebellar AtaxiaNCT06633003
Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients
A study testing Antrodia cinnamomea Products in people with Spinocerebellar Ataxia, run by ALPS Biotech CO. LTD at 1 site in Taiwan.
Trial summary
This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. To investigate the advancements in neurodegenerative diseases. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Spinocerebellar Ataxia
- What is being tested?
- Antrodia cinnamomea Products
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Sep 2024to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 30 to 70 years, whose native language is Chinese.
- Patients diagnosed with Spinocerebellar Ataxia.
- Subjects with a score below 30 on the Scale for the Assessment and Rating of Ataxia (SARA scale).
- Individuals who can read and write in Chinese and communicate in Chinese.
- Agree to participate in the study.
Who cannot join
- Patients with severe systemic diseases, such as heart or respiratory failure, liver or kidney failure, severe brain injury, prolonged bed rest, or incurable malignancies.
- Pregnant women and breastfeeding mothers.
- Patients who have taken Antrodia cinnamomea products within the last 6 months prior to the trial.
- Patients with other factors that prevent them from continuing to participate in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Cancer Center
Taipei
Irene Tsai, +886925772995, ibox526@gmail.com
MingChe Kuo
About this study
This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. To investigate the advancements in neurodegenerative diseases.
Read the detailed description
This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients: a randomized, double-blind, placebo-controlled crossover design, and parallel clinical investigation.
- Conditions
- Spinocerebellar Ataxia
- Being tested
- Antrodia cinnamomea Products
- Keywords
- Neuroinflammatory Diseases, Nervous System Diseases, Spinocerebellar Ataxia, Antrodia Cinnamomea
- Medical subject headings
- Spinocerebellar Ataxias, Neuroinflammatory Diseases, Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antrodia cinnamomea ProductsDietary supplement
Placebo-controlled crossover design:
- Dietary Supplement: Antrodia Cinnamomea Products
- Dietary Supplement: Placebo
Antrodia cinnamomea ProductsDietary supplement
A arm :
Stage I :
- Dietary Supplement: Antrodia Cinnamomea Products
Stage II:
- Dietary Supplement: Placebo
B arm :
Stage I :
- Dietary Supplement: Placebo
Stage II:
- Dietary Supplement: Antrodia Cinnamomea Products
| Study group | Role | What they receive |
|---|---|---|
| Stage I: Antrodia Cinnamomea Products + Stage II: Placebo | Active comparator | Crossover design:
During 0 week~8 weeks is Stage I :
• Dietary Supplement: Antrodia Cinnamomea Products
During 16 weeks~ 24 weeks is Stage II:
• Dietary Supplement: Placebo Receives: Dietary Supplement: Antrodia cinnamomea Products |
| Stage I: Placebo + Stage II: Antrodia Cinnamomea Products | Placebo comparator | Crossover design:
During 0 week~8 weeks is Stage I :
• Dietary Supplement: Placebo
During 16 weeks~ 24 weeks is Stage II:
• Dietary Supplement: Antrodia Cinnamomea Products Receives: Dietary Supplement: Antrodia cinnamomea Products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in the total score of the Scale for the Assessment and Rating of Ataxia (SARA) at 48 weeks in subjects is compared to natural history.
To compare the effectiveness of Antrodia Cinnamomea Products in treating SCA, as measure by the Scale for the Assessment and Rating of Ataxia (SARA), in subjects randomized to treatment after 24 weeks of treatment. The SARA is a scale with a range of 0 to 40, where an increase in the total score indicates a worsening of symptoms.
Measured: Up to 48 weeks of treatment.
Secondary outcomes (6)
Resting-state electroencephalogram (EEG) will be collected
Successful attainment of Resting-state electroencephalogram (EEG). To compare the EEG recordings in different frequency band change before, during, and after the Antrodia Cinnamomea Products used.
Measured: Up to 48 weeks of treatment.
Collect Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma.
Monitor Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma.
Measured: Up to 48 weeks of treatment.
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses.
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses.
The evaluator should start the stopwatch as soon as the patient touches the first peg. The evaluator should stop the stopwatch once the last peg is in the container.
Scoring:
The number of seconds it takes for the patient to complete the test, where an increase in the total score indicates a worsening of symptoms.
Measured: Up to 48 weeks of treatment.
Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study.
PSQI is a self-rated questionnaire for sleep quality. It includes 18 items across 7 components; C1: Sleep quality, C2: Sleep latency, C3: Sleep duration, C4: Sleep efficiency, C5: Sleep disturbance, C6: Use of sleep medication, C7: Daytime dysfunction. Each component is scored 0-3 (0 = no difficulty, 3=severe difficulty), and total score ranging from 0 to 21. It included seven components with a global PSQI score > 5 is indicative of poor sleep quality.
Measured: Up to 48 weeks of treatment.
Hospital Anxiety and Depression Scale (HADS)
Hospital Anxiety and Depression Scale (HADS) questionnaire. The HADS is a fourteen item scale. Seven of the items relate to anxiety and seven relate to depression. The anxiety and depression subscales each range from 0 to 21, with higher scores indicating higher anxiety/depression complains. Patients were defined as having anxiety or depression or both if the score was 8 or more in the corresponding subscale.
Measured: Up to 48 weeks of treatment.
The 8 Metre Walk Test.
The 8 Metre Walk Test is a performance measure used to assess walking or gait speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function
Scoring The total time taken to ambulate 8 meters is recorded. Timing starts when the toes pass the 0-meter mark. Timing stops when the toes pass the 8-meter mark. The 8-meter is then divided by the total time taken (in seconds) to completed. Increase in the total time indicates a worsening of symptoms.
Measured: Up to 48 weeks of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2024
- Study start16 Sep 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinocerebellar AtaxiaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Placebo-controlled crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALPS Biotech CO. LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MingChe Kuo, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06633003
- Sponsor's protocol ID
- 202404011RSA
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients
- ClinicalTrials.gov ID
- NCT06633003
- Acronym / sponsor ID
- 202404011RSA
- Conditions
- Spinocerebellar Ataxia
- Keywords
- Neuroinflammatory Diseases, Nervous System Diseases, Spinocerebellar Ataxia, Antrodia Cinnamomea
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- ALPS Biotech CO. LTDIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 9 Oct 2024 (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 study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. To investigate the advancements in neurodegenerative diseases.
Detailed description
This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients: a randomized, double-blind, placebo-controlled crossover design, and parallel clinical investigation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Placebo-controlled crossover design.
| Arm | Type | Receives |
|---|---|---|
| Stage I: Antrodia Cinnamomea Products + Stage II: Placebo | Active comparator | Dietary Supplement: Antrodia cinnamomea ProductsCrossover design: During 0 week~8 weeks is Stage I : • Dietary Supplement: Antrodia Cinnamomea Products During 16 weeks~ 24 weeks is Stage II: • Dietary Supplement: Placebo |
| Stage I: Placebo + Stage II: Antrodia Cinnamomea Products | Placebo comparator | Dietary Supplement: Antrodia cinnamomea ProductsCrossover design: During 0 week~8 weeks is Stage I : • Dietary Supplement: Placebo During 16 weeks~ 24 weeks is Stage II: • Dietary Supplement: Antrodia Cinnamomea Products |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 30 to 70 years, whose native language is Chinese.
- Patients diagnosed with Spinocerebellar Ataxia.
- Subjects with a score below 30 on the Scale for the Assessment and Rating of Ataxia (SARA scale).
- Individuals who can read and write in Chinese and communicate in Chinese.
- Agree to participate in the study.
Key exclusion criteria (4 listed)
- Patients with severe systemic diseases, such as heart or respiratory failure, liver or kidney failure, severe brain injury, prolonged bed rest, or incurable malignancies.
- Pregnant women and breastfeeding mothers.
- Patients who have taken Antrodia cinnamomea products within the last 6 months prior to the trial.
- Patients with other factors that prevent them from continuing to participate in this study.
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 |
|---|---|---|
| Antrodia cinnamomea ProductsPlacebo-controlled crossover design: * Dietary Supplement: Antrodia Cinnamomea Products * Dietary Supplement: Placebo | Dietary supplement | Stage I: Antrodia Cinnamomea Products + Stage II: Placebo |
| Antrodia cinnamomea ProductsA arm : Stage I : • Dietary Supplement: Antrodia Cinnamomea Products Stage II: • Dietary Supplement: Placebo B arm : Stage I : • Dietary Supplement: Placebo Stage II: • Dietary Supplement: Antrodia Cinnamomea Products | Dietary supplement | Stage I: Placebo + Stage II: Antrodia Cinnamomea Products |
Primary outcome
Change from Baseline in the total score of the Scale for the Assessment and Rating of Ataxia (SARA) at 48 weeks in subjects is compared to natural history.
Time frame: Up to 48 weeks of treatment.
To compare the effectiveness of Antrodia Cinnamomea Products in treating SCA, as measure by the Scale for the Assessment and Rating of Ataxia (SARA), in subjects randomized to treatment after 24 weeks of treatment. The SARA is a scale with a range of 0 to 40, where an increase in the total score indicates a worsening of symptoms.
6 secondary outcomes
Resting-state electroencephalogram (EEG) will be collected
Time frame: Up to 48 weeks of treatment.
Collect Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma.
Time frame: Up to 48 weeks of treatment.
The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses.
Time frame: Up to 48 weeks of treatment.
Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study.
Time frame: Up to 48 weeks of treatment.
Hospital Anxiety and Depression Scale (HADS)
Time frame: Up to 48 weeks of treatment.
The 8 Metre Walk Test.
Time frame: Up to 48 weeks of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
MingChe Kuo principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antrodia cinnamomea Products in people with Spinocerebellar Ataxia, run by ALPS Biotech CO. LTD at 1 site in Taiwan.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yu Hsuan Chang (+886955551989, hsuan1989@alps.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in the total score of the Scale for the Assessment and Rating of Ataxia (SARA) at 48 weeks in subjects is compared to natural history. (time frame: Up to 48 weeks of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2024.