ISRCTN15168684已完成未知
A study of plasminogen in subjects with Alzheimer’s disease
Talengen Institute of Life Sciences0 个研究点目标入组 6 人开始时间: 2023年1月27日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6
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
- •1. Written informed consent/assent obtained prior to any assessment performed
- •2. Age 50 to 100 years old (including 50 and 100 years old), male or female
- •3. Meet the diagnostic criteria of likely ad dementia of the National Institute on aging Alzheimer's disease association (NIA-AA) (2011)
- •4. The subjects are primary school graduates/graduates and above, and have the ability to complete the cognitive ability test and other tests specified in the program
- •5. Memory loss lasted for at least 6 months and tended to worsen gradually
- •6. Subjects with mild or moderate illness: 0 = total score of MMSE = 26
- •7. Total score of Clinical Dementia Rating Scale (CDR): Mild dementia: CDR = 1.0; Moderate dementia: CDR = 2.0
排除标准
- •1. Dementia caused by other reasons: vascular dementia, central nervous system infection, Creutzfeldt Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (such as drug poisoning, alcoholism, carbon monoxide poisoning, etc.), important physical diseases (such as hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space occupying lesions (such as subdural hematoma, brain tumor), endocrine disorders (such as thyroid disease, parathyroid disease), and vitamin B12, folic acid deficiency or any other known cause;
- •2. Have suffered from central nervous system diseases (including stroke, optic neuromyelitis, epilepsy, etc.);
- •3. Subjects who were diagnosed with psychiatric disorders according to DSM-V criteria, including schizophrenia or other mental diseases, bipolar disorder, severe depression or delirium;
- •4. Abnormal laboratory indexes: liver function (ALT and AST) exceeded 1.5×ULN, renal function (CR) exceeded 1.5×ULN, and creatine kinase exceeded 2×ULN;
- •5. Untreated hypertensive and hypotensive subjects at screening, or hypertensive subjects with uncontrolled hypertension after treatment; subjects with good blood pressure control after treatment can be determined by the investigator to be suitable for inclusion in this study;
- •6. Within 1 month of the screening visit, the subject has new or ongoing unstable or serious heart, lung, liver, kidney and hematopoietic diseases according to the judgment of the researcher, and does not meet the conditions for clinical research;
- •7. Clinically, people with significant allergic reaction history, especially drug allergy history, or known allergy to this product and its excipients;
- •8. Dyspepsia, esophageal reflux, gastric bleeding or peptic ulcer disease, frequent heartburn (= once a week) or any surgical operation that may affect drug absorption (such as partial/total gastrectomy, partial/total small bowel resection and cholecystectomy) within 6 months before screening
- •9. Alcohol or drug abusers
- •10. Human immunodeficiency virus antibody (ant HIV) and Treponema pallidum antibody (ant TP) are positive
- •11. Those who are currently using and cannot stop using drugs for Alzheimer's disease
- •12. Female subjects with positive pregnancy test or lactation and subjects unable to take effective contraceptive measures or have family planning
- •13. Participated in other clinical trials within 3 months before the screening visit
- •14. There are other situations that the researcher believes are not suitable for participation in this study
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