Mild or moderate intensity amnestic variant Alzheimers disease
Conditions
Interventions
Group without treatment: Patients without specific treatment for Alzheimer's disease, amnestic variant and with mild or moderate intensity, attended in internal medicine, geriatrics and neurology cons
Observational Study
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 50 years or older. 2. MMES score of 14 to 23 points, inclusive. 3. Patients with a GDS score of 3 to 5 points, inclusive. 4. Patients with a CDR score of 1 to 2 points, inclusive. 5. If the ADAScog11 scale is available, it must be between 16 and 45 points, inclusive.
Exclusion criteria
Exclusion criteria: 1. A pre-existing medical condition (other than Alzheimer's disease) that may be contributing to cognitive decline in the subject (substance abuse, AIDS, syphilis, stroke or other cerebrovascular disease, head trauma, brain tumor). 2. Patients with vascular dementia at baseline will be excluded, according to the criteria of the National Institute of Neurological Disorders and Stroke-International Association for Research and Education in Neurosciences (NINDS-AIREN) (Appendix 14). 3. Unstable/uncontrolled psychiatric illness at baseline (e.g., major depression, schizophrenia, bipolar disorder). 4. History of cancer, Parkinson's disease, stage 4-5 kidney disease, moderate-to-severe liver disease, or moderate-to-severe anemia. 5. History of clinical disorders consistent with vitamin B12 and/or folic acid deficiency, such as hematological and neurological disorders. 6. History of clinical disorders consistent with hypothyroidism or hyperthyroidism. 7. Patients who, at the time of evaluation, in addition to cognitive impairment, presented with gait disturbances (slow, unsteady, and frequent falls) and loss of bowel and bladder control, a triad known as Hakim-Adams, which raises suspicion of normal pressure hydrocephalus. 8. Subjects receiving treatment with antipsychotics, barbiturates, monoamine oxidase inhibitors, benzodiazepines, and antidepressants at doses that could compromise the accurate interpretation of the scales used. 9. Patients who are currently receiving or have previously received any of the medications approved for Alzheimer's disease (donepezil, rivastigmine, galantamine, memantine, lecanemab, donanemab, neuroEPO) 10. Alcoholism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MMES (Mental State Examination score. Score of 14 to 23 points, inclusive). Measurement time: 0, 52, 78, 104 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. ADAS-cog11 score (ADAS-cog11 Scale). Measurement time: 0, 52, 78, 104 weeks. 2. CIBIC plus (measured by CIBIC plus Scale). Measurement time: 0, 52, 78, 104 weeks. 3. CIBIS (measured by CIBIS Scale). Measurement time: 0, 52, 78, 104 weeks. 4. Psychometric performance (Neuropsychiatric Inventory measured by NPI). Measurement time: 0, 52, 78, 104 weeks. 5. Degree of dementia (measured by GDS). Measurement time: 0, 52, 78, 104 weeks. 6. Montreal Cognitive Assessment (measured by MoCA Scale). Measurement time: 0, 52, 78, 104 weeks. 7. Validity index in basic activities of daily living (measured by Katz Index). Measurement time: 0, 52, 78, 104 weeks. 8. Validity index in instrumental activities of daily living (measured by the Lawton Index). Measurement time: 0, 52, 78, 104 weeks. 9. Clinical Dementia Rating Scale (measured by the CDR Scale). Measurement time: 0, 52, 78, 104 weeks. 10. Cornell Scale (measured by the Cornell Scale). Measurement time: 0, 52, 78, 104 weeks. | — |
Countries
Cuba
Contacts
Public ContactTaimy Amador Nunnez
Center for Molecular Immunology (CIM)
Outcome results
None listed