RPCEC00000232
Completed
Phase 2
Assessing The Effectiveness and safety of Nasal NeuroEpo management in patients with Alzheimer's mild/moderate - ATHENEA
Center of Molecular Immunology (CIM)0 sites174 target enrollmentFebruary 1, 2017
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Mild to moderate Alzheimer's
- Sponsor
- Center of Molecular Immunology (CIM)
- Enrollment
- 174
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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