ClinicalTrials.gov record NCT06633003

Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

Age30 years old to 70 years old

SexAll

LocationTaiwan

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

A randomized, double-blind, placebo-controlled crossover study testing oral Antrodia cinnamomea products in adults with spinocerebellar ataxia. Participants receive the supplement in one treatment period and placebo in another. Outcomes measured include ataxia rating, EEG, blood markers, hand dexterity, sleep, mood, and walking over up to 48 weeks.

What it is studying. The study tests whether taking Antrodia cinnamomea products by mouth changes clinical symptoms and biomarkers in people with spinocerebellar ataxia compared with placebo. Main measures include the Scale for the Assessment and Rating of Ataxia (SARA) and other assessments such as resting EEG, blood tests (including neurofilament light chain and cytokine assays), the Nine-Hole Peg Test for hand dexterity, sleep and mood questionnaires, and an 8‑metre walk test.

What the researchers hope to learn. To evaluate whether oral Antrodia cinnamomea products alter clinical ataxia scores and related measures in spinocerebellar ataxia; to collect EEG and blood biomarker data (including plasma exosome cytokines and neurofilament light chain); and to compare motor and patient-reported outcomes across treatment periods.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This study aims to assess the effect of Antrodia cinnamomea on clinical symptoms in spinocerebellar ataxia patients. To investigate the advancements in neurodegenerative diseases.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Dietary supplement: Antrodia cinnamomea Products

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

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.

Exclusion criteria

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a randomized, double-blind, placebo-controlled crossover study in which each participant will take oral Antrodia cinnamomea products for one study period and a matching placebo during another period. Over up to 48 weeks, participants will complete clinical exams and rating scales (including SARA), performance tests (Nine‑Hole Peg Test, 8‑metre walk), sleep and mood questionnaires (PSQI, HADS), resting-state EEG recordings, and blood draws for plasma tests (cytokines/exosomes and neurofilament light chain). The registry gives no further detail here about exact visit schedule or other participant supports.

How the study is structured. Interventional trial. Participants are randomly assigned, in a double-blind crossover, to one of two sequences: supplement first then placebo, or placebo first then supplement. Treatment periods are 8 weeks each (Stage I and Stage II) with an interval between them, and assessments continue up to 48 weeks. Placebo control and blinding are used so neither participants nor study staff know the sequence during treatment periods.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

The listed sites are in Taiwan. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on spinocerebellar ataxia

Clinical trials30 trials listed for spinocerebellar ataxiaEvery trial the registry lists for spinocerebellar ataxia, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in spinocerebellar ataxia researchLatest monthly update: September 2026. Includes: NBP trial result. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Sep 16, 2024
Primary completion: Aug 31, 2027 (estimated)
Study completion: Aug 31, 2027 (estimated)
Target enrollment: 60 participants (estimated)
Last updated on registry: Dec 10, 2024
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: ALPS Biotech CO. LTD

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Yu Hsuan Chang 📞 +886955551989 ✉ hsuan1989@alps.com.tw
Irene Tsai 📞 +886925772995 ✉ ibox526@gmail.com

Participating sites (1)

National Taiwan University Cancer CenterRecruiting
Taipei · Taiwan
- Irene Tsai · +886925772995 · ibox526@gmail.com
- MingChe Kuo

Terms used on this page · explanations by MedicalUpdates.ai

Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
randomized: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
double-blind: Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
placebo-controlled: A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
crossover: Each participant receives more than one intervention, one after the other, usually with a gap (a washout) in between. Participants act as their own comparison.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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