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

NCT06633003 | Recruiting DMC

• 1 other identifier: 202404011RSA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinocerebellar Ataxia

Keywords

Neuroinflammatory Diseases; Nervous System Diseases; Spinocerebellar Ataxia; Antrodia Cinnamomea

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 48 weeks of treatment.

Secondary Outcomes (6)

• Resting-state electroencephalogram (EEG) will be collected

  Up to 48 weeks of treatment.

• Collect Cytokines assay of plasma exosomes and Neurofilament Light Chain (NfL) Test of plasma.

  Up to 48 weeks of treatment.

• The Nine-Hole Peg Test (9HPT) is used to measure finger dexterity in patients with various neurological diagnoses.

  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.

  Up to 48 weeks of treatment.

• Hospital Anxiety and Depression Scale (HADS)

  Up to 48 weeks of treatment.

Other Outcomes (1)

• Check Fecal levels of Human Calprotectin and Fecal levels of Human Lactoferrin.

  Up to 48 weeks of treatment.

Study Arms (2)

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

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

Dietary Supplement: Antrodia cinnamomea Products

Interventions

Antrodia cinnamomea Products DIETARY_SUPPLEMENT

Placebo-controlled crossover design: * Dietary Supplement: Antrodia Cinnamomea Products * Dietary Supplement: Placebo

Stage I: Antrodia Cinnamomea Products + Stage II: Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ALPS Biotech CO. LTD: lead

Study Sites (1)

National Taiwan University Cancer Center

Taipei, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinocerebellar Ataxias; Neuroinflammatory Diseases; Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebellar Ataxia; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Spinocerebellar Degenerations; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MingChe Kuo

  National Taiwan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yu Hsuan Chang

CONTACT

+886955551989; hsuan1989@alps.com.tw

Irene Tsai

CONTACT

+886925772995; ibox526@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled crossover design.

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: October 9, 2024
• Study Start: September 16, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: December 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)