Quality of Life and safety of the nutritional supplement Deprexil® or Placebo in combination with cognitive stimulation treatment in patients with Mild Cognitive Impairment and Mild Alzheimer's Dementia.
- Conditions
- Mild Cognitive Impairment and Mild Alzheimer's Dementia
- Registration Number
- RPCEC00000435
- Lead Sponsor
- Catalysis Laboratories, S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method