Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease

Korábbi kezelés

• Skull trauma or recent intracranial surgery.
• Use of anticoagulants, a medication to prevent harmful blood clots (warfarin, heparin or NOAC).
• Patients receiving treatment with AChE-I or Memantine who are not stable for 12-weeks prior to screening.
• Patients receiving treatment with psychoactive that can compromise the clinical trial results or neuropsychological tests.
• Have prior skull fracture or abnormality (nasal defect, deviated septum).
• Have any prior sinus or nose surgery (rhinoplasty).

Más betegség

• Patients with neurological symptoms or signs that suggest another cause of dementia.
• Known clotting disorders.
• Patients with a history of hypersensitivity to rhEPO.
• Patients with known allergy to any ingredients of the product.
• Patients with a history of alcoholism and/or drug dependence.
• Have a history of abnormal nasal or sinus symptoms.
• Congenital cranial facial disorders.

Laborértékek

• 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.
• Have known bleeding problem (low platelets-thrombocytopenia), recurrent nose bleeds (>3 year).

Egyéb

• Evident mental disability or other limitation that prevents the patient or caregiver from administering the study evaluations.
• Patients who present nasal irritation (sneezing) or a runny nose before starting treatment.
• Patients who present asthma attack at the beginning of the treatment.
• Patients with chronic rhinosinusitis.
• Have recent nasal trauma (fracture in the last 2 months).
• Have acute inflammation inside the nose.

• Patients >= 50 years of age, to reflect the population that will be treated and to avoid younger populations who may be suffering dementia from a cause other than Alzheimer's Disease.
• Patients with Global Deterioration Scale (GDS) between 3 to 5 points (inclusive).
• Clinical Dementia Rating (CDR) - GS score 1-2 at screening.
• Patients with permeable airways.
• Patients (or caregiver, if the patient cannot) grant consent to participate in the study by signing the informed consent form.
• Patient with caregiver is physically and mentally willing to collaborate with the investigation.
• Mini-Mental State Examination (MMSE) score between 14 and 26 (inclusive) at screening