RPCEC00000410
Not yet recruiting
Phase 4
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 sites1,456 target enrollmentSeptember 22, 2022
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- mild-moderate Alzheimer's disease
- Sponsor
- Center of Molecular Immunology (CIM)
- Enrollment
- 1456
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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