Prospective, double-blind, randomized, placebo-controlled, longitudinal study to evaluate the effectiveness of lithium microdose in the treatment of Alzheimer's disease.

Faculdade de Ciências Médicas da Santa Casa de São Paulo0 个研究点开始时间: 2015年6月23日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•Will be included in the study: patients clinical diagnosed with Alzheimer's disease by the Neurology Department of Medical School of Santa Casa Sao Paulo Hospital, based on the Diagnostic and Statistical Manual of Mental Disorders (DSM, fourth edition), National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and Alzheimer's Disease and Related Disorders Association; Patients who have a score 1 or 2 in the Clinical Dementia Rating (CDR), characterizing mild and moderate stages of AD, respectively; Patients who are using Alzheimer’s disease FDA-approved drug for at least six months, prescribed by the Neurology Department of Medical School of Santa Casa Sao Paulo Hospital; Patients who have 60 years old or older; Education: everybody could be included in this study, but the years of education must be considered to memory score tests; adjustments should be made in accordance with the scholarity; Do not include prescription of drugs with central nervous system action in the first six months of treatment, unless strictly necessary conditions and it must be highlighted in the patient evolution; Agreement with and signing of the informed consent form; Having a caregiver (familiar member or formal caregiver) who is responsible for the patient's participation in the study.

•Will be excluded in the study patients who don’t have a clinical diagnosis of Alzheimer's disease; patients who have a score 3 in clinical dementia rating, i.e. late stage dementia; patients who suffer from diseases that may have contraindications for the use of lithium carbonate, as: kidney failure; patients who have a lithium intolerance; patients who have used lithium for other conditions; patients with lithium serum levels above the acceptable range, i.e. 1.2 mEq/ L in plasma; patients with renal failure; patients with hypothyroidism or goiter, if not controlled; violation of the protocol; loss of follow-up; discontinuing treatment; by request of patient or caregiver; death; patients who don’t agree to participate in the study. Notes: Frequent and prevalent comorbidities in the elderly are not considered exclusion criteria, such as hypertension, diabetes, vitamin B12 deficiency, among others. These patients will be enrolled in the study with appropriate notes and the possible differences observed in these patients will be compared with normal elderly.

发起方

Faculdade de Ciências Médicas da Santa Casa de São Paulo