mild-moderate Alzheimers disease -
Conditions
Interventions
NeuroEPO group (Experimental): Subjects will receive neuroEPO, 0.5 mg (equivalent 0.5 mL), administered nasally 3 times per week (Monday, Wednesday, and Friday), for 104 weeks. NeuroEPO is a nasal for
Administration, Intranasal
Sponsors
Center for Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients from clinical trials RPCEC00000409 and RPCEC00000410 who have completed these studies and experienced a benefit from the use of NeuralCIM. 2. Patient and caregiver who provide consent to participate in the study by signing the informed consent form. 3. Patient with a caregiver who is physically and mentally capable of understanding the study and willing to collaborate with the research. 4. Patients with patent airways.
Exclusion criteria
Exclusion criteria: 1. Medical condition acquired before resuming treatment with NeuralCIM that may be contributing to a worsening of cognitive impairment in the subject (substance abuse, AIDS, syphilis, stroke or other cerebrovascular disease, head trauma, brain tumor). 2. Unstable/uncontrolled psychiatric illness prior to resuming treatment with NeuralCIM (e.g., major depression, schizophrenia, bipolar disorder). 3. History of cancer, Parkinson's disease, stage 4-5 kidney disease, moderate-to-severe liver disease, moderate-to-severe anemia before resuming treatment with NeuralCIM. 4. History of clinical disorders consistent with hypothyroidism or hyperthyroidism before resuming treatment with NeuralCIM. 5. Subjects who were receiving treatment with antipsychotics, barbiturates, monoamine oxidase inhibitors, benzodiazepines and antidepressants before resuming treatment with NeuralCIM, at doses that may compromise the proper interpretation of the scales that will be used. 6. Patients who are receiving some of the approved drugs for Alzheimer's disease (donepezil, rivastigmine, galantamine, memantine, lecanemab, donanemab) before resuming treatment with NeuralCIM. 7. Alcoholism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ADAS-Cog11 scale score from treatment restart to 12 months post-restart (0–9 points: normal; 10–15 points: mild cognitive impairment [MCI]; 16–24 points: mild stage, GDS 3 or GDS 4; 25–30 points: moderate stage, GDS 4; 31–45 points: moderate-to-severe stage, GDS 4 or GDS 5; >45 points: severe stage, GDS 6 or higher). Measurement time: At baseline and Week 52. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.- Proportion of patients with stability/improvement in ADAS-Cog11 at 24 months (0–9 points: normal; 10–15 points: mild cognitive impairment [MCI]; 16–24 points: mild stage, GDS 3 or GDS 4; 25–30 points: moderate stage, GDS 4; 31–45 points: moderate-to-severe stage, GDS 4 or GDS 5; >45 points: severe stage, GDS 6 or higher). Measurement time: Week 104. 2.- Degree of dementia (Measured by GDS, where 1 = no 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: At baseline, weeks 52, and 104. 3.- General cognitive status (Measured by MoCA, where =26 points: normal; 25–22 points: MCI; 21–18 points: mild impairment; 17–14 points: moderate impairment; <14 points: severe impairment). Measurement time At baseline, weeks 52, and 104. 4.- Functional status index for basic activities of daily living (Measured by the Katz Index, where: A. Independent in all functions; B. Independent in all functions except one; C. Independent in all functions except bathing and one other; D. Independent in all functions except bathing, dressing, and one other; E. Independent in all functions except bathing, dressing, toileting, and one other; F. Independent in all functions except bathing, dressing, toileting, mobility, and one other; G. Dependent in all functions; H. Dependent in at least two functions but not classifiable as C, D, E, or F). Measurement time: At baseline, weeks 52, and 104. 5.- Functional status index for instrumental activities of daily living (Measured by the Lawton Index, where: Women: 0-1 point = total dependence, 2-3 points = severe, 4-5 points = moderate, 6-7 points = mild, 8 points = independent; Men: 0 points = total dependence, 1 point = severe, 2-3 points = moderate, 4 points = mild, 5 points = independent). Measurement time: At baseline, weeks 52, and 104. 6.- Psycho-behavioral man | — |
Countries
Cuba
Contacts
Public ContactLidia Morejon Gamboa
Center of Molecular Immunology (CIM)
Outcome results
None listed