Study Design : Open Label, Prospective, Non-Randomised, Non-Comparative Single Arm Clinical Study

Indication : Parkinson’s Disease

Investigational Product : AFO202 Beta Glucan

Comparator: None.   

Dose : 1 sachet of  Beta Glucan AFO 202 to be consumed with water 30 minutes after meal; once in the morning, once in the afternoon and once in evening

Dosage : Three Sachets per day for 90 days

Subject Population : Adults aged ≥18 years of age, all genders inclusive; with  diagnosis/history of Parkinson’s Disease

Number of Subjects : 35 Evaluable Subjects

Treatment Arms : One. Single Arm

Treatment Duration : 90 days.

Assessments

1.         Unified Parkinson’s Disease Rating Scale (UPDRS)

2.         The Clinical Global Impressions Improvement Scale  (Based on Magnetic Resonance 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 of the study:

Parkinson’s Disease (PD) is a progressive, neurodegenerative disease that causes characteristic motor symptoms of tremor, bradykinesia, and postural instability. It affects approximately 1% to 2% of adults over age 65 and 4% of adults over age 80. Approximately 60,000 Americans are diagnosed with PD annually and more than one million persons are currently living with the disease in the United States (Parkinson Disease Foundation, 2015). Due to rising life expectancy, the number of people with PD is expected to increase by more than 50% by 2030. Males are predominantly affected with a male-to female ratio of 3:2. Caucasians are more commonly affected than African Americans or Asians.

PD is a progressive disease that occurs over the course of 10 years or more. In late-stage PD, medication resistance is a major problem. After approximately 17 years of disease, up to 80% of patients with PD have freezing of gait with risk of falls and up to 50% of patients report choking. Dementia is a late sign, occurring in 60% of patients with 10 years of disease duration and 83% in those with 20-year history. Late-stage symptoms, such as dementia and falls, are commonly the reason for admission to long-term care and high mortality.

Purpose of the Study

AFO-202 is a black yeast–derived beta-glucan that has been in consumption for the past two decades and has been shown to have potential as a nutritional supplement to balance metabolic levels of glucose, lipids, and immunomodulators. an earlier study on beta-glucan from yeast showed reduction in alpha-synuclein expression on the brain substantia nigra in Parkinson’s rat model.

Dietary intake of beta-glucans aids to reduce the risk factors in diabetes and associated complications. In addition, beta-glucans also supports to promote wound healing and alleviate ischemic heart injury. Dietary intake of beta-glucans helps in reducing blood glucose by delaying stomach emptying so that the dietary glucose is absorbed more gradually because the molecular weight of ß-1, 3-1, 6-glucan is high, since degrading enzymes are not present in the human digestive tract, it is presumably hardly absorbed into the body. These changes reduce the feeling of hunger cause by rapid decrease in blood glucose. Thus, beta glucans may decrease appetite and reduce food intake. Another postulated mechanism by which beta-glucans reduce blood glucose level is mediated by signal pathway through PI3K/Akt activation. The administration of beta glucans could restore the decreased PI3K/Akt in diabetes as decreased PI3K/Akt activity has been shown to play a key role in the pathogenesis of diabetes.