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NCT Number: NCT06633003

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

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

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Key information

Conditions

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

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Taiwan University Cancer Center

Taipei, Taiwan

Location status: Recruiting

Location contact

Irene Tsai

CONTACT

[email protected]

+886925772995

MingChe Kuo

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Antrodia cinnamomea Products

Dietary Supplement

Placebo-controlled crossover design:

  • Dietary Supplement: Antrodia Cinnamomea Products
  • Dietary Supplement: Placebo

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.

    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.

Secondary outcomes

  1. Resting-state electroencephalogram (EEG) will be collected

    Time frame: Up to 48 weeks of treatment.

    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.

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

    Time frame: Up to 48 weeks of treatment.

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

  3. 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.

    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.

  4. 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.

    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.

  5. Hospital Anxiety and Depression Scale (HADS)

    Time frame: Up to 48 weeks of treatment.

    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.

  6. The 8 Metre Walk Test.

    Time frame: Up to 48 weeks of treatment.

    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.

Other outcomes

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

    Time frame: Up to 48 weeks of treatment.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Irene Tsai

CONTACT

[email protected]

+886925772995

Yu Hsuan Chang

CONTACT

[email protected]

+886955551989

Sponsors and collaborators

Lead sponsor

ALPS Biotech CO. LTD

Industry

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 9, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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