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.

Study Overview

• Status: Recruiting
• Conditions: Spinocerebellar Ataxia
• Intervention / Treatment: Dietary supplement: Antrodia cinnamomea Products; Dietary supplement: Antrodia cinnamomea Products

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yu Hsuan Chang; Phone Number: +886955551989; Email: hsuan1989@alps.com.tw
• Study Contact Backup: Name: Irene Tsai; Phone Number: +886925772995; Email: ibox526@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • National Taiwan University Cancer Center
    • Contact: Irene Tsai; Phone Number: +886925772995; Email: ibox526@gmail.com
    • Contact: MingChe Kuo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Stage I: Antrodia Cinnamomea Products + Stage II: Placebo; 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; Placebo-controlled crossover design: Dietary Supplement: Antrodia Cinnamomea Products; Dietary Supplement: Placebo; Dietary supplement: Antrodia cinnamomea Products; 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
Placebo Comparator: Stage I: Placebo + Stage II: Antrodia Cinnamomea Products; 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; Placebo-controlled crossover design: Dietary Supplement: Antrodia Cinnamomea Products; Dietary Supplement: Placebo; Dietary supplement: Antrodia cinnamomea Products; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	Up to 48 weeks of treatment.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Check Fecal levels of Human Calprotectin and Fecal levels of Human Lactoferrin.	Check Fecal levels of Human Calprotectin and Fecal levels of Human Lactoferrin.	Up to 48 weeks of treatment.

Collaborators and Investigators

• Sponsor: ALPS Biotech CO. LTD
• Investigators: Principal Investigator: MingChe Kuo, National Taiwan University Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): December 10, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Nervous System Diseases; Spinocerebellar Ataxia; Neuroinflammatory Diseases; Antrodia Cinnamomea
• Additional Relevant MeSH Terms: Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Genetic Diseases, Inborn; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Spinal Cord Diseases; Dyskinesias; Cerebellar Diseases; Ataxia; Cerebellar Ataxia; Spinocerebellar Ataxias; Spinocerebellar Degenerations
• Other Study ID Numbers: 202404011RSA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No