RPCEC00000410尚未招募4 期
Evaluation of the effectiveness and safety of the administration of neuroEPO in patients with mild-moderate Alzheimer's disease phenotype amnesic variant
Center of Molecular Immunology (CIM)0 个研究点目标入组 1,456 人开始时间: 2022年9月22日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,456
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment
入排标准
- 年龄范围
- 19 years 至 one（—）
- 性别
- All
入选标准
- •1.- Patients and/or caregivers who give their consent to participate in the study by signing the informed consent form.
- •2.- Patient with a physically and mentally trained caregiver to understand the study and willing to collaborate with the research.
- •3.- Patients aged = 19 years.
- •4.- Patients with GDS from 3 to 5 points.
- •5.- Patients with CDR of 1 to 2 points.
- •6.- ADAScog11 score from 16 to 30 points.
- •7.- Patients with permeable airways.
排除标准
- •1. Medical condition (not Alzheimer's disease) that may be contributing to cognitive impairment in the subject (substance abuse, AIDS, syphilis, stroke or other cerebrovascular disease, head trauma, brain tumor).
- •2. Patients with vascular dementia will be excluded, according to the criteria of the National Institute of Neurological Disorders and Stroke-Association Internationale pour la Recherche et 1'Enseignement en Neurosciences) (NINDS-AIREN).
- •3. Unstable/uncontrolled psychiatric illness (example: major depression, schizophrenia, bipolar disorder).
- •4. History of unstable angina, acute myocardial infarction, cancer, Parkinson's, kidney disease, liver disease, coagulation disorders, anemia.
- •5. Subjects receiving treatment with antipsychotics, barbiturates, monoamine oxidase inhibitors, benzodiazepines and antidepressants, at doses that may compromise neuropsychological tests.
- •6. Patients receiving any of the approved medications for Alzheimer's disease (donepezil, rivastigmine, galantamine, memantine, aducanumab, neuroEPO)
- •7. Patients with a history of hypersensitivity to hr-EPO or any component of the product.
- •8. Patients with nasal irritation (sneezing) or runny nose before starting treatment.
- •9. Alcoholism.
研究者
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