Citalopram for agitation in Alzheimer's disease: design and methods.
Citalopram for agitation in Alzheimer's disease: design and methods.
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DOI:
10.1016/j.jalz.2011.01.007
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发表时间:
2012
期刊:
影响因子:
--
通讯作者:
CitAD Research Group
中科院分区:
文献类型:
--
作者:
Drye LT;Ismail Z;Porsteinsson AP;Rosenberg PB;Weintraub D;Marano C;Pelton G;Frangakis C;Rabins PV;Munro CA;Meinert CL;Devanand DP;Yesavage J;Mintzer JE;Schneider LS;Pollock BG;Lyketsos CG;CitAD Research Group
Agitation is one of the most common neuropsychiatric symptoms of Alzheimer’s disease (AD), and is associated with serious adverse consequences for patients and caregivers. Evidence-supported treatment options for agitation are limited. The citalopram for agitation in Alzheimer’s disease (CitAD) study was designed to evaluate the potential of citalopram to ameliorate these symptoms. CitAD is a randomized, double-masked, placebo-controlled multicenter clinical trial with two parallel treatment groups assigned in a 1:1 ratio and randomization stratified by clinical center. The study has eight recruiting clinical centers, a chair’s office and a coordinating center located in university settings in the United States and Canada. 200 people having probable Alzheimer’s disease with clinically significant agitation and without major depression are being recruited. Patients are randomized to receive citalopram (target dose of 30 mg/day) or matching placebo. Caregivers of patients in both treatment groups receive a structured psychosocial therapy. Agitation will be compared between treatment groups using the NeuroBehavioral Rating Scale and the AD Cooperative Study- Clinical Global Impression of Change which are the primary outcomes. Functional performance, cognition, caregiver distress and rates of adverse and serious adverse events will also be measured. The authors believe the design elements in CitAD are important features to be included in trials assessing the safety and efficacy of psychotropic medications for clinically significant agitation in Alzheimer’s disease.
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DOI:
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