Exploratory, monocentric, placebo-controlled, randomized, double-blind clinical trial to evaluate the Quality of Life and safety of the nutritional supplement Deprexil® in combination with cognitive stimulation treatment in patients with Mild Cognitive Impairment and Mild Alzheimer's Dementia.

Catalysis Laboratories, S0 个研究点目标入组 100 人开始时间: 2024年3月7日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Parallel. Purpose: Treatment

•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.

发起方

Catalysis Laboratories, S