Mild Cognitive Impairment and Mild Alzheimer's Dementia
Conditions
Interventions
Patients with Mild Cognitive Impairment
Deprexil Group (Experimental): Deprexil + Cognitive stimulation. Deprexil will be administered one vial (30 ml) Deprexil® oral solution every 12 hours (given af
Sponsors
Catalysis Laboratories, SL
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged = 60 years. 2. Time of evolution of the disease less than 2 years. 3. Patients who have the results of laboratory tests, imaging tests (CT), as well as neurocognitive and functional tests. 4. Patients and/or reliable informant who grant their consent to participate in the study by signing the informed consent model. Inclusion Criteria for MCI 1.Patients who meet the diagnostic criteria for MCI according to the International Working Group on Mild Cognitive Impairment. Inclusion Criteria for Mild Alzheimer's Dementia 1. Patients who meet the diagnostic criteria for mild Alzheimer's dementia according to DSM-IV.
Exclusion criteria
Exclusion criteria: 1. Patients with severe loss of vision, hearing or communication skills. 2. Patients with the presence of an active systemic disease (e.g., cancer, rheumatoid arthritis, lupus erythematosus, etc.) or another chronic neurological disease (e.g., Parkinson's disease, multiple sclerosis) or psychiatric disease (e.g. major depression, schizophrenia, mental retardation, bipolar disorder). 3. Patients with infectious diseases of the Central Nervous System. 4. Patients with a history of craniocerebral trauma. 5. Patients with a history of known cerebrovascular disease or brain tumor, or diagnosed by CT, at the time of inclusion. 6. Patients at risk of frequent bleeding or taking medications that thin the blood (warfarin). 7. Patients addicted to alcohol or drugs, or treated with psychotropic drugs at the time of inclusion. 8. Patients with elevated thyroid hormone levels with clinical significance. 9. Patients who are participating in another clinical trial. 10. Patients with a known allergy to any ingredient of the supplement or placebo. Note: In patients receiving vitamin or nutritional supplements (vitamin C, vitamin B12, folic acid, vitamin B6, ginkgo biloba), it should be taken as a concomitant treatment and the doses to be ingested should be controlled at the doctor's discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of Life (SF-36 health questionnaire. The questionnaire has 36 items distributed in 8 dimensions: physical function (10 items), physical role (4 items), body pain (2 items), general health (5 items), vitality (4 items), social function (2 items), emotional role (3 items) and mental health (5 items); item 2 is related to health transition. Each item is expressed on a scale from 0 to 100 with a point cut-off at 50, above and below which there are positive or negative health states. The change in final value with respect to the baseline value will be measured in the scores of the domains and summary scores of the questionnaire. The following categories will be established: poor Quality of Life if the total score is from 0 to 25, regular Quality of Life from 26 to 50, good Quality of Life from 51 to 75 and excellent Quality of life from 76 to 100 points). Measurement time: At baseline, month 3 and one week after the end of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional capacity (It will be evaluated using the Lawton and Brody scale where 0 to 1 point is considered Total dependence, Severe dependence from 2 to 3 points, Moderate dependence from 4 to 5 points, Light dependence from 6 to 7 points, and Independence 8 points.). Measurement time: At baseline, month 3 and, a week after the end of treatment. 2. Cognitive Status (It will be evaluated using the Folstein Mini Mental State Examination (MMSE), the Reisberg Global Impairment Scale (GDS) and the Montreal Cognitive Assessment (MoCA) Test. The MMSE gives a score where from 24 to 30 points is evaluated as “no cognitive deficit”, between 18 and 23 points as “Slight cognitive deficit” and 17 points or less as “Severe cognitive deficit”. The GDS gives a score that ranges from 1 (absence of cognitive deficit) to 7 (very severe cognitive deficit) and the MoCA that gives a maximum score of 30 points, where a score equal to or greater than 26 points is considered normal (no alteration of cognitive functions) and less than 26 indicates alteration of cognitive functions). Measurement time: At baseline, month 3 and, a week after the end of treatment. 3. Brain metabolism (It will be evaluated through a neuroimaging study, Positron Emission Tomography (PET). The limbic structures (hippocampal complex, medial thalamus, mammillary body, and the posterior cingulate; or temporo-parietal region) and the structure will be studied. A favorable response will be considered if an increase in metabolism is observed when there are 2 or more standard deviations above the controls provided by the equipment as an average according to the areas studied in the final evaluation with respect to the baseline result, and unfavorable if contrary). Measurement time: At baseline and, a week after the end of treatment. | — |
Countries
Cuba
Contacts
Public ContactKeyla Martinez Herve
National Coordinating Center for Clinical Trials
Outcome results
None listed