Mild to moderate Alzheimer's
Conditions
Interventions
Group A (experimental): 0.5 mg NeuroEPO by intranasal route, 3 times a week for 4 weeks (induction period) and, then continuing with 1mg weekly for 44 weeks (maintenance period).
Group B (experimenta
Erythropoietin
Administration, Intranasal
Placebos
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion 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
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. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-cog11 Value (ADAS-cog11 scale). Measuring time: at 6 months, 12 months (If the probability of success at 6 months is low). | — |
Secondary
| Measure | Time frame |
|---|---|
| Related to efficacy: CIBIC plus (CIBIC plus scale). Measuring time: at 0, 6 and 12 months. Validity index in the basic activities of daily life (Measured by Index of Katz and Barthel). Measuring time: at 0, 6 and 12 months. Index of validity in the instrumental activities of daily life (Measured by Lawton Index). Measuring time: at 0, 6 and 12 months. Psychometric performance (Measured by Neuropsychiatric Inventory (NPI)). Measuring time: at 0, 6 and 12 months. Functional neuroimaging (by SPECT). Measuring time: at 0, 6 and 12 months. Event-related evoked potentials for P-300, N-400. Measuring time: at 0, 6 and 12 months. Mental flexibility (Measured by Trail Making, (Stroke Test)). Measuring time: at 0, 6 and 12 months. Working Memory (Measured by Trail Making). Measuring time: at 0, 6 and 12 months. Motor response rate (Measured by Trail Making). Measuring time: at 0, 6 and 12 months. Working memory (Measured by Digito spam). Measuring time: at 0, 6 and 12 months. Sustained attention (Measured by Digito spam). Measuring time: at 0, 6 and 12 months. Visuoconstructive function (Measured by Copia King figure and late evocation). Measuring time: at 0, 6 and 12 months. Visual memory (Measured by Copia King figure and late evocation). Measuring time: at 0, 6 and 12 months. Verbal fluency (Measured by Verbal Fluency Test (FAS)). Measuring time: at 0, 6 and 12 months. Degree of dementia (Measured by the GDS). Measuring time: at 0, 6 and 12 months. Related to safety: Blood pressure (mm/Hg). Measuring time: in each evaluation at 2, 6 and 12 months and in each administration of the product. Adverse Events-AE (Severity of AE (serious or not), Type of AE (accordint to Regulation 45/2007 CECMED), Intensity of AE (mild, moderate, serious), Causality relationship (Very likely, likely, possible, unlikely, unrelated or non-evaluable), Attitude about the drug (No change, dose reduction, temporary interruption of treatment, definitive discontinuation of treatment), Outcome (Revers | — |
Countries
Cuba
Contacts
Public ContactLeslie Perez Ruiz
Center of Molecular Immunology (CIM)
Outcome results
None listed