mild-moderate Alzheimers disease
Conditions
Interventions
Group A - neuroEPO (Experimental): 0.5 mg dose of neuroEPO (equivalent to 0.5 mL), 0.25 mL nasal drops in each nostril, 3 times a week (Monday, Wednesday and Friday), for 78 weeks.
Group B - Donepezil
Erythropoietin
Donepezil
Tablets
Administration, Intranasal
Administration, Oral
NeuroEPO
nasal drops
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion 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 caregiver physically and mentally able to understand the study and willing to collaborate with the research. 3. Patients aged = 50 years. 4. Patients with GDS from 3 to 5 points, inclusive. 5. Patients with a CDR of 1 to 2 points, inclusive. 6. ADAScog11 score from 16 to 30 points, inclusive. 7. Patients with patent airways.
Exclusion criteria
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, psychiatric illness). 2. History of unstable angina, acute myocardial infarction, cancer, Parkinson's disease, coagulation disorders, anemia, and chronic/decompensated liver or kidney disorders. 3. Any contraindication that does not allow MRI, SPECT-CT or PET-CT to be performed. 4. Subjects receiving treatment with antipsychotics, barbiturates, monoamine oxidase inhibitors, benzodiazepines and antidepressants, at doses that may compromise neuropsychological tests. 5. Patients who are receiving any of the medications approved for Alzheimer's disease (donepezil, rivastigmine, galantamine, memantine, aducanumab, NeuralCIM) 6. Patients with a history of hypersensitivity to hr-EPO or any component of the product. 7. Patients with known sensitivity to Donepezil hydrochloride, piperidine derivatives or some of the excipients used in the formulation. 8. Alcoholism. 9. Patients receiving treatment with anticoagulants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAScog11 (10-15 points: mild cognitive impairment. 16-24 points: mild stage. 25-30 points: moderate stage. 31-45 points: moderate-severe stage. > 45 points : severe stage). Measurement time: Baseline (before starting treatment), weeks 52 and 78. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy related: 1. Degree of dementia. Measured by GDS (1 Absence of cognitive deficit. 2 Very mild cognitive deficit, 3 Mild cognitive deficit, 4 Moderate cognitive deficit, 5 Moderately severe cognitive deficit, 6 Severe cognitive deficit, 7 Very severe cognitive deficit. Measurement time: start, weeks 52 and 78. 2. Classification of dementia by CDR (0: No deterioration.0.5: Doubtful deterioration.1: Mild deterioration.2: Moderate deterioration. 3: Severe deterioration.). Measurement time: start, weeks 52 and 78. 3. General cognitive status. Measured by MoCA (= 26 points: Normal, 25-22 points: MCI, 21-18 points: mild impairment, 17-14 points: moderate impairment, < 14 points: severe impairment. Measurement time: start, weeks 52 and 78. 4. Global assessment of the patient's condition. Measured by CIBIC plus (1 point: Marked improvement. 2 points: Moderate improvement. 3 points: Minimal improvement. 4 points: No change. 5 points: Minimal worsening. 6 points: Moderate worsening. 7 points: Marked worsening. Measurement time: weeks 52 and 78. 5. Validity index in the basic activities of daily life. Measured by Katz Index (A. Independent in all functions B. Independent in all functions except any one, C. Independent in all functions except in the bathroom and any other, D. Independent in all functions except in the bathing, dressing and any other, E. Independent in all functions except bathing, dressing, toileting and any other, F. Independent in all functions except bathing, dressing, toileting, mobility and any other , G. Dependent on all functions, H. Dependent on at least two functions, but not classifiable as C, D, E or F) . Measurement time: start, weeks 52 and 78. 6. Validity index in instrumental activities of daily living. Measured by Lawton Index (Female: 0-1 point Total Dependence, 2-3 points Severe, 4-5 points Moderate, 6-7 points mild, 8 points Autonomous. Male: 0 point Total Dependence, 1 point Severe, 2- 3 points Moderate, 4 points mild, 5 points Autono | — |
Countries
Cuba
Contacts
Public ContactLeslie Perez Ruiz
Center of Molecular Immunology (CIM)
Outcome results
None listed