ISRCTN13536327进行中（未招募）Unknown
Effectiveness of a Probiotic K10 in managing health outcomes in Parkinson’s disease and in early stage (mild cognitive impairment to mild dementia) Alzheimer’s disease
Micillic Ltd.0 个研究点目标入组 166 人开始时间: 2023年8月22日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 166
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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