Effectiveness of Probiotic K10 in Managing Health Outcomes in Parkinson and Alzheimer Disease

Prior treatment

• Parkinsonism due to drugs including neuroleptics, alpha-methyldopa, reserpine, metoclopramide, valproic acid.
• Sufficient deficiency to require changes in dopaminergic medication treatment during follow-up compared to baseline treatment schedule.
• Unstable dose of active CNS therapies.
• Participation in other drug studies or use of other investigational drugs within 30 days prior to the Screening Visit.
• History of structural brain disease, such as previous trauma causing damage detected on a CT scan or MRI, hydrocephalus, or previous brain neoplasms.
  • Alzheimer's Exclusion Criteria:
• Use of any investigational agents within 30 days prior to screening
• Major surgery within 8 weeks prior to the Baseline Visit

Other illness

• Other parkinsonian disorders.
• History of symptomatic stroke.
• Other severe and uncompensated illnesses, including severe psychiatric illnesses.
• Patients with active cardiovascular, restrictive peripheral vascular, or cerebrovascular disease in the past year.
• History of active epilepsy within the past 5 years.
• History of electroconvulsive therapy.
• History of any brain surgery for Parkinson's disease.
• Significant neurological disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis, or seizure disorder
• Major depression treated in the past 12 months, major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse
• History of invasive cancer within the past two years (excluding non-melanoma skin cancer)
• Uncontrolled cardiac conditions or severe unstable medical illnesses
• Antiretroviral therapy for human immunodeficiency virus (HIV)
• Conditions that will contribute to oxidative stress: current cigarette or cigar smokers (within past month), diabetics on insulin or poorly controlled on oral hypoglycemics

Other

• Parkinson's Exclusion Criteria:
• Use of antioxidants (such as selegiline, rasagiline, vitamins E and C), additional supplemental vitamins or minerals, regular use of neuroleptics, chloramphenicol, valproic acid, warfarin.
• Modified Hoehn and Yahr score of 3 or more on Screening Visit or Baseline Visit.
• UPDRS tremor score of 3 or greater at Screening Visit or Baseline Visit.
• Use of appetite suppressants within 60 days of the Baseline Visit.
• Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol.

• Eligibility criteria for individuals with Parkinson's. Ages eligible to participate in the study: 18 years or older Accept healthy volunteers: No. Gender Eligibility for Study: All genders
• Presence of all 3 cardinal features of Parkinson's disease (tooth tremor, bradykinesia, and rigidity). Clinical signs must be asymmetrical.
• Diagnosis of Parkinson's disease within 5 years of the Screening Visit.
• Age 18 years or older.
• Women must not be of childbearing potential or must use an approved form of contraception during the trial period.
  • Eligibility Criteria for Individuals with Alzheimer's. Eligible ages to participate in the study: 60 -85 years Accept healthy volunteers: No. Gender Eligibility for Study: All genders
• Men or women between the ages of 60 and 85
• Diagnosis of probable Alzheimer's disease
• Portuguese-speaking, English-speaking; Spanish-speaking if the individual site allows
• Study partner or caregiver to ensure compliance
• Mini-Mental State Exam score at screening visit greater than 14
• Stable medical condition for 3 months prior to screening, with no significant abnormal liver, kidney, or blood studies.
• Able to take oral medications
• Modified Hachinski Ischemic Index less than or equal to 4
• CT or MRI from the onset of memory impairment, demonstrating the absence of a clinically significant focal lesion
• Physically acceptable for this study, as confirmed by medical history, physical examination, neurological examination, and clinical testing