RPCEC00000409招募中3 期
Evaluation of the efficacy and safety of the administration of neuroEPO/neuroEPO-donepezil vs. donepezil in patients with mild-moderate Alzheimer's disease.
Center of Molecular Immunology (CIM)0 个研究点目标入组 413 人开始时间: 2022年9月20日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 413
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
- Randomized controlled trial. Masking: Open. Control group: Active. Assignment: Other. Purpose: Treatment
入排标准
- 年龄范围
- 50 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 caregiver physically and mentally able to understand the study and willing to collaborate with the research.
- •3. Patients aged = 50 years.
- •4. Patients with GDS from 3 to 5 points, inclusive.
- •5. Patients with a CDR of 1 to 2 points, inclusive.
- •6. ADAScog11 score from 16 to 30 points, inclusive.
- •7. Patients with patent 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, psychiatric illness).
- •2. History of unstable angina, acute myocardial infarction, cancer, Parkinson's disease, coagulation disorders, anemia, and chronic/decompensated liver or kidney disorders.
- •3. Any contraindication that does not allow MRI, SPECT-CT or PET-CT to be performed.
- •4. Subjects receiving treatment with antipsychotics, barbiturates, monoamine oxidase inhibitors, benzodiazepines and antidepressants, at doses that may compromise neuropsychological tests.
- •5. Patients who are receiving any of the medications approved for Alzheimer's disease (donepezil, rivastigmine, galantamine, memantine, aducanumab, NeuralCIM)
- •6. Patients with a history of hypersensitivity to hr-EPO or any component of the product.
- •7. Patients with known sensitivity to Donepezil hydrochloride, piperidine derivatives or some of the excipients used in the formulation.
- •8. Alcoholism.
- •9. Patients receiving treatment with anticoagulants.
研究者
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