An Open Label, Prospective, Non Randomised, Single Arm Pilot Clinical Study to Evaluate the Safety, Tolerability and Effectiveness of AFO-202 strain of Aureobasidium pullulans produced β 1,3-1,6 Glucans in Patients with Parkinson’s Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- 2.The Clinical Global Impressions Improvement Scale (Based on Magnetic Resonance Imaging) : Score of ≤3 at end of study.
研究概览
简要总结
Study Design : Open Label, Prospective, Non-Randomised, Non-Comparative Single ArmClinical Study
Indication : Parkinson’s Disease
InvestigationalProduct : AFO202 Beta Glucan
Comparator: None.
Dose : 1 sachet of Beta Glucan AFO202 to be consumed with water 30 minutes after meal; once in the morning, oncein the afternoon and once in evening
Dosage : Three Sachets per day for 90 days
SubjectPopulation : Adults aged ≥18 years of age, allgenders inclusive; with diagnosis/historyof Parkinson’s Disease
Number of Subjects: 35 Evaluable Subjects
Treatment Arms: One. Single Arm
TreatmentDuration : 90 days.
Assessments
1. Unified Parkinson’s Disease RatingScale (UPDRS)
2. The Clinical Global ImpressionsImprovement Scale (Based on MagneticResonance Imaging)
3. Levodopa equivalent dose treatment
4. Constipation Severity Score
5. α-synuclein
6. Serum Neurofilament light chain
7. Serum Creatinine Kinase
8. Gut Microbiota Metagenome Sequencing
Background ofthe study:
Parkinson’s Disease (PD) is a progressive, neurodegenerative diseasethat causes characteristic motor symptoms of tremor, bradykinesia, and posturalinstability. It affects approximately 1% to 2% of adults over age 65 and 4% ofadults over age 80. Approximately 60,000 Americans are diagnosed with PDannually and more than one million persons are currently living with thedisease in the United States (Parkinson Disease Foundation, 2015). Due torising life expectancy, the number of people with PD is expected to increase bymore than 50% by 2030. Males are predominantly affected with a male-to femaleratio of 3:2. Caucasians are more commonly affected than African Americans orAsians.
PD is a progressive disease that occurs over the course of 10 yearsor more. In late-stage PD, medication resistance is a major problem. Afterapproximately 17 years of disease, up to 80% of patients with PD have freezingof gait with risk of falls and up to 50% of patients report choking. Dementiais a late sign, occurring in 60% of patients with 10 years of disease durationand 83% in those with 20-year history. Late-stage symptoms, such as dementiaand falls, are commonly the reason for admission to long-term care and highmortality.
Purpose of the Study
AFO-202 is a black yeast–derived beta-glucan that has been inconsumption for the past two decades and has been shown to have potential as anutritional supplement to balance metabolic levels of glucose, lipids, andimmunomodulators. an earlier study on beta-glucan from yeast showed reductionin alpha-synuclein expression on the brain substantia nigra in Parkinson’s ratmodel.
Dietary intake of beta-glucans aids to reduce the risk factors indiabetes and associated complications. In addition, beta-glucans also supportsto promote wound healing and alleviate ischemic heart injury. Dietary intake ofbeta-glucans helps in reducing blood glucose by delaying stomach emptying sothat the dietary glucose is absorbed more gradually because the molecular weightof ß-1, 3-1, 6-glucan is high, since degrading enzymes are not present in thehuman digestive tract, it is presumably hardly absorbed into the body. Thesechanges reduce the feeling of hunger cause by rapid decrease in blood glucose.Thus, beta glucans may decrease appetite and reduce food intake. Anotherpostulated mechanism by which beta-glucans reduce blood glucose level ismediated by signal pathway through PI3K/Akt activation. The administration ofbeta glucans could restore the decreased PI3K/Akt in diabetes as decreasedPI3K/Akt activity has been shown to play a key role in the pathogenesis ofdiabetes.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adults aged ≥18 years, diagnosed with Parkinson’s Disease 2.Subjects with Parkinson’s Disease that meet the clinical diagnostic criteria of the brain bank of the Parkinson’s Disease Association of the United Kingdom.
- •3.Subjects who have been on the same treatment regimen for a minimum of three months prior to enrolment and are willing to not make major changes to their standard treatment regimen until the end of the treatment period.
- •4.Subject/Caregiver/LAR who will be answering the evaluation questions must have the basic computer literacy to be able to use Google Forms 5.Subject/LAR who is willing to give written informed consent for participation, able to comprehend and understand the responsibilities during treatment period.
- •6.Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
排除标准
- •1.Subjects with advanced stage disease 2.Subjects with history that suggests possible allergic reaction to the key constituents of the investigational product.
- •3.Subjects who have difficulty in swallowing or any condition that makes per oral medication difficult or impossible 4.Subjects who have undergone major surgical procedure 4 weeks prior to randomisation.
- •5.Subjects who are on anti-depressants, anti-psychotics or presenting in psychiatric condition that would interfere with the parameters of the clinical study.
- •6.Subjects with CKD or other diseases that impair normal kidney function.
- •7.Subjects with known history of clinically significant endocrine, gastrointestinal,cardiovascular,hematological,hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology or co-morbid to the study indication.
- •8.Females who are pregnant or lactating or planning to become pregnant during the study period.
- •9.Subjects who are currently participating or have participated in a clinical trial upto 90 days prior to randomisation 10.Subjects, who in the opinion of the investigator are unsuitable for enrolment.
结局指标
主要结局
2.The Clinical Global Impressions Improvement Scale (Based on Magnetic Resonance Imaging) : Score of ≤3 at end of study.
时间窗: Day 1 and Day 90
8.Gut Microbiota Metagenome Sequencing : Improvement from baseline in the stool sample analysis.
时间窗: Day 1 and Day 90
1.Unified Parkinson’s Disease Rating Scale (UPDRS) : Reduction of ≥5 scores from baseline
时间窗: Day 1 and Day 90
3.Levodopa equivalent dose treatment : Reduction of ≥10% dose from baseline.
时间窗: Day 1 and Day 90
5.α-synuclein : Improvement from baseline
时间窗: Day 1 and Day 90
4.Constipation Severity Score : Reduction of ≥10 scores from baseline.
时间窗: Day 1 and Day 90
6.Serum Neurofilament light chain : Improvement from baseline
时间窗: Day 1 and Day 90
7.Serum Creatinine Kinase : Reduction from baseline
时间窗: Day 1 and Day 90
次要结局
- Only for Subjects with Diabetes Mellitus Type II(1.Fasting Blood Glucose : Improvement from baseline)