Assessing The Effectiveness and safety of Nasal NeuroEpo management in patients with Alzheimer's mild/moderate - ATHENEA

Center of Molecular Immunology (CIM)0 个研究点目标入组 174 人开始时间: 2017年2月1日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•1- Patients with ages = to 50 years.
•2- Patients with GDS between 2 to 4 points.
•3- Patients with permeable airways.
•4- Patients (or tutor, if the patient can not) grant consent to participate in the study by signing the informed consent model.
•5- Patient with caregiver or legal tutor physically and mentally willing to collaborate with the investigation.

•1- Negative patient or caregiver (if the patient is incapacitated) to participate in the study.
•2- Evident mental disability or other limitation that prevents the patient or caregiver from signing their consent or hindering the study evaluations.
•3- Patients with neurological symptoms or signs that suggest another cause of dementia.
•4- Skull trauma or recent intracranial surgery.
•5- Clotting disorders known.
•6- Patients where coexistence of another disease or condition that may lead to significant disability (cancer, septic embolism, endocarditis, myeloproliferative disease, creatinine> 3 mg / dl (265µmol / L), hyperkalemia> 5.0 mmol / L, chronic/severe liver or kidney or heart disorders.
•7- Patients with a history of hypersensitivity to EPO-hr.
•8- Patients with known allergy to any ingredients of the product.
•9- Patients who present nasal irritation (sneezing) or a runny nose before starting treatment.
•10- Patients who present asthma attack at the begining of the treatment.
•11- Patients receiving treatment with AChE-I or Memantine.
•12- Patients receiving treatment with psychoactive that compromise the clinical trial results or neuropsychological tests.
•13- Patients with a history of alcoholism and / or drug dependence.

发起方

Center of Molecular Immunology (CIM)