Improvement of symptoms in patients with Parkinson's and Alzheimers disease Nervous System Diseases
Conditions
Interventions
In this study, researchers will conduct a randomized, placebo-controlled, phase III trial of a probiotic preparation (Probiotic K10) to evaluate its use as a viable treatment option for neurodegenerat
Sponsors
Micillic Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Parkinson's arm 1. Presence of all 3 cardinal features of Parkinson's disease (tooth tremor, bradykinesia, and rigidity). Clinical signs must be asymmetrical. 2. Diagnosis of Parkinson's disease within 5 years of the Screening Visit. 3. Age 18 years or older. 4. Women must not be of childbearing potential or must use an approved form of contraception during the trial period. Alzheimer's arm 1. Men or women between the ages of 60 and 85 2. Diagnosis of probable Alzheimer's disease 3. Portuguese-speaking, English-speaking; Spanish-speaking if the individual site allows 4. Study partner or caregiver to ensure compliance 5. Mini-Mental State Exam score at screening visit greater than 14 6. Stable medical condition for 3 months prior to screening, with no significant abnormal liver, kidney, or blood studies. 7. Able to take oral medications 8. Modified Hachinski Ischemic Index less than or equal to 4 9. CT or MRI from the onset of memory impairment, demonstrating the absence of a clinically significant focal lesion 10. Physically acceptable for this study, as confirmed by medical history, physical examination, neurological examination, and clinical testing
Exclusion criteria
Exclusion criteria: Parkinson's arm: 1. Parkinsonism due to drugs including neuroleptics, alpha-methyldopa, reserpine, metoclopramide, valproic acid. 2. Use of antioxidants (such as selegiline, rasagiline, vitamins E and C), additional supplemental vitamins or minerals, regular use of neuroleptics, chloramphenicol, valproic acid, warfarin. 3. Other parkinsonian disorders. 4. Modified Hoehn and Yahr score of 3 or more on Screening Visit or Baseline Visit. 5. UPDRS tremor score of 3 or greater at Screening Visit or Baseline Visit. 6. History of symptomatic stroke. 7. Sufficient deficiency to require changes in dopaminergic medication treatment during follow-up compared to baseline treatment schedule. 8. Other severe and uncompensated illnesses, including severe psychiatric illnesses. 9. Patients with active cardiovascular, restrictive peripheral vascular, or cerebrovascular disease in the past year. 10. Unstable dose of active CNS therapies. 11. Use of appetite suppressants within 60 days of the Baseline Visit. 12. History of active epilepsy within the past 5 years. 13. Participation in other drug studies or use of other investigational drugs within 30 days prior to the Screening Visit. 14. History of electroconvulsive therapy. 15. History of any brain surgery for Parkinson's disease. 16. 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 arm: 1. Significant neurological disease such as Parkinson's disease, stroke, brain tumor, multiple sclerosis, or seizure disorder 2. Major depression treated in the past 12 months, major mental illness such as schizophrenia, or recent (in past 12 months) alcohol or substance abuse 3. History of invasive cancer within the past two years (excluding non-melanoma skin cancer) 4. Use of any investigational agents within 30 days prior to screening 5. Major surgery within 8 weeks prior to the Baseline Visit 6. Uncontrolled cardiac conditions or severe unstable medical illnesses 7. Antiretroviral therapy for human immunodeficiency virus (HIV) 8. Conditions that will contribute to oxidative stress: current cigarette or cigar smokers (within past month), diabetics on insulin or poorly controlled on oral hypoglycemics 9. Blindness, deafness, language difficulties or any other disability which may prevent the participant from participating or cooperating in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Parkinson's group 1.1. Parkinson's Disease rating scale (MDS- UPDRS) at baseline visit, 45 days and 90 days or the time of sufficient disability to require dopaminergic therapy or study closure, whichever occurs first. 1.2. PD quality of life scale (PDQ-39) at baseline visit, 45 days and 90 days or the time of sufficient disability to require dopaminergic therapy or study closure. 1.3. Anxiety levels, mood and caregiver burden in neuropsychiatric evaluation from baseline to T90 or the time of sufficient disability to require dopaminergic therapy or study closure. 2. Alzheimer's group 2.1. Cognitive status measured by brief battery focused on evaluating memory, visuo-spatial skills, constructive skills, language, praxys and attention. at baseline visit, 45 days and 90 days. 2.2. DA Quality of Life Scale baseline visit, 45 days and 90 days. 2.3. Anxiety levels, mood and caregiver burden in neuropsychiatric evaluation from baseline to T90 or the time of sufficient disability to require dopaminergic therapy or study closure. | — |
Secondary
| Measure | Time frame |
|---|---|
| Indirect measurement of emotional stress measured by urinary cortisol dosage at baseline visit, 45 days and 90 days. | — |
Countries
Brazil
Contacts
Public ContactDeivis Oliveira Guimaraes
Outcome results
None listed