Treatment of apathy in Alzheimer's disease with modafinil

用莫达非尼治疗阿尔茨海默病的冷漠

• 批准号: 7126511
• 负责人: LAURA L FRAKEY
• 金额: $ 4.96万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-01 至 2007-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7126511
• 关键词: Alzheimer' s disease; behavioral /social science research tag; caregivers; central nervous system stimulants; cholinesterase inhibitors; clinical research; clinical trials; combination chemotherapy; drug screening /evaluation; functional ability; human subject; human therapy evaluation; nervous system disorder chemotherapy; neuropsychological tests; neuropsychology; piperidine; postdoctoral investigator; psychopharmacology; questionnaires; serotonin inhibitor

DESCRIPTION (provided by applicant): The purpose of this study is to evaluate the efficacy of modafinil as an adjunctive treatment for Alzheimer's Disease (AD)-related apathy, and to examine the impact of a reduction in apathy on performance of activities of daily living (ADLs) in patients and on burden experienced by their caregivers. Apathy is seen in up to 70% of patients with mild to moderate stage AD. Prior research in this laboratory has shown that apathy is related to failure on ADLs. Patients with apathy require more support and assistance thus placing a larger burden on their caregivers. Effective treatments for apathy in AD have not been identified. The proposed study will explore the efficacy of modafinil, a psychostimulant medication, used adjunctively with cholinesterase inhibitors (CHIs) in treatment of apathy in AD patients. It will also examine the effect of a reduction in apathetic symptomatology on patient ADL performance and caregiver burden. A double-blind placebo controlled design will be used. Fifty AD patients with apathy will be recruited and randomized into either the Standard Care (CHI only) or the Experimental (CHI +modafinil) group. Measures of apathy, ADL functioning and caregiver burden will be collected at study enrollment and after eight weeks of pharmacologic treatment. This research is expected to lead to a new pharmacologic treatment for apathy symptoms in AD, and better understanding of the relationship between apathy and functional status.

描述（由申请人提供）：本研究的目的是评估莫达非尼作为阿尔茨海默氏病（AD）相关的冷漠的辅助治疗方法，并研究了冷漠对患者和由其护理人员体验的日常生活（ADL）活动（ADLS）表现的降低的影响。多达70％的轻度至中度阶段AD患者中有冷漠。该实验室的先前研究表明，冷漠与ADL失败有关。冷漠的患者需要更多的支持和帮助，从而给护理人员带来更大的负担。尚未确定对AD中冷漠的有效治疗方法。拟议的研究将探索莫达非尼（一种精神刺激药物）的功效，该药物与胆碱酯酶抑制剂（CHI）在AD患者的冷漠治疗中辅助使用。它还将研究减少冷漠症状学对患者ADL表现和护理人员负担的影响。将使用双盲安慰剂控制设计。五十名AD AD患者将被招募并随机分为标准护理（仅CHI）或实验性（CHI +Modafinil）组。在研究入学率和药物治疗八周后，将收集冷漠，ADL功能和护理人员负担的措施。预计这项研究将导致新的药物治疗AD中的冷漠症状，并更好地理解冷漠和功能状况之间的关系。