Effectiveness of lithium microdose in the treatment of Alzheimer's disease.
- Conditions
- Alzheimer's diseaseC10.228.140.380.100
- Registration Number
- RBR-6cf6rp
- Lead Sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
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.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome will be to determine whether the microdose lithium will stabilize the cognitive decline of Alzheimer's disease patients, for that will be used clinical tests, such as: cognitive abilities, anxiety behavior and autonomy to do daily activities.<br><br>Stabilization of cognitive decline will be considered statistically different when significance level was lower than 5% (p<0.05) between treated group and placebo group. The data will be collected each three months and analysed at 12, 24 and 36 months. <br><br>Cognition status will be clinically assessed by means of tests such as: MoCA (Montreal Cognitive Assessment); Mini-Mental State Examination (MMSE); CDR – Clinical Dementia Rating; ADAS-cog – Alzheimer’s Disease Assessment Scale-cognitive subscale; NPI-C - Neuropsychiatric Inventory – Clinician Rating Scale; Functionality and anxiety will also be clinically assessed by the Barthel index and GAI (Geriatric Anxiety Inventory), respectively. <br>
- Secondary Outcome Measures
Name Time Method The secondary outcome will be to evaluate the possible collateral effects of lithium microdose, thereunto will be measured considering the follow parameters (indication of reference levels): the lithium blood levels, which will be quantified by inductively coupled plasma mass spectrometry (ICP-MS); markers of kidney function, quantified by analysis of Urea (13 a 43 mg/dL) and Creatinine (0,6 a 1,3 mg/dL); markers of thyroid function, quantified by levels of TSH (0,27 a 4,20 uUI/mL) and free T4 (0,93 a 1,7 ng/dL) hormones and markers of liver functions, quantified by levels of GGT (Men<73UI/L and Women<38 UI/L), AST (8 a 33 U/L), ALT (Men:10 a 40 U/L and Women: 7 a 35 U/L), total bilirubin (0,3 a 1,2 ng/dL) and fractions (direct: up to 0,2 ng/dL e indirect: up to 1,0 ng/dL) and alkaline phosphatase (Men:90 a 360 U/L and Women: 70 a 290 U/L) of the all patients.<br><br>The treatment will be considered safe if the levels of markers and analytes remain within normality levels. <br>