Clinical trial NCT06633003: Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients
Official title: Effects of Oral Administration of Antrodia Cinnamomea Products for Clinical Symptoms in Spinocerebellar Ataxia Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinocerebellar Ataxia
Keywords: Neuroinflammatory Diseases
Nervous System Diseases
Spinocerebellar Ataxia
Antrodia Cinnamomea
Lead sponsor: ALPS Biotech CO. LTD
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Placebo-controlled crossover design.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Adults aged 30 to 70 years, whose native language is Chinese.
2. Patients diagnosed with Spinocerebellar Ataxia.
3. Subjects with a score below 30 on the Scale for the Assessment and Rating of Ataxia (SARA scale).
4. Individuals who can read and write in Chinese and communicate in Chinese.
5. Agree to participate in the study.

Exclusion Criteria:

1. Patients with severe systemic diseases, such as heart or respiratory failure, liver or kidney failure, severe brain injury, prolonged bed rest, or incurable malignancies.
2. Pregnant women and breastfeeding mothers.
3. Patients who have taken Antrodia cinnamomea products within the last 6 months prior to the trial.
4. Patients with other factors that prevent them from continuing to participate in this study.

Primary outcomes:
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.
timeFrame: Up to 48 weeks of treatment.
Secondary outcomes:
measure: Resting-state electroencephalogram (EEG) will be collected
timeFrame: Up to 48 weeks of treatment.
measure: Collect Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma.
timeFrame: Up to 48 weeks of treatment.
measure: The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses.
timeFrame: Up to 48 weeks of treatment.
measure: Changes From Start of Administration (Week 0) in Pittsburgh Sleep Quality Index (PSQI) Global Score at End of Study.
timeFrame: Up to 48 weeks of treatment.
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Up to 48 weeks of treatment.
measure: The 8 Metre Walk Test.
timeFrame: Up to 48 weeks of treatment.
Other outcomes:
measure: Check Fecal levels of Human Calprotectin and Fecal levels of Human Lactoferrin.
timeFrame: Up to 48 weeks of treatment.
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Cancer Center
Study officials:
affiliation: National Taiwan University Cancer Center
name: MingChe Kuo
role: PRINCIPAL_INVESTIGATOR
References: