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: 6999478
• 负责人: LAURA L FRAKEY
• 金额: $ 4.57万
• 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/6999478
• 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病（AD）相关冷漠的辅助治疗的功效，并检查冷漠减少对日常生活活动表现的影响（ADL）患者及其护理人员所经历的负担。高达 70% 的轻度至中度 AD 患者会出现冷漠。该实验室之前的研究表明，冷漠与日常生活活动失败有关。冷漠的患者需要更多的支持和帮助，从而给他们的护理人员带来更大的负担。 AD 冷漠的有效治疗方法尚未确定。拟议的研究将探讨莫达非尼（一种精神兴奋药物）与胆碱酯酶抑制剂（CHIs）辅助治疗 AD 患者冷漠的疗效。它还将检查冷漠症状的减少对患者 ADL 表现和护理人员负担的影响。将使用双盲安慰剂对照设计。将招募 50 名患有冷漠的 AD 患者并随机分为标准护理组（仅 CHI）或实验组（CHI +莫达非尼）。将在研究入组时和八周药物治疗后收集冷漠、ADL 功能和护理人员负担的测量结果。这项研究有望为 AD 冷漠症状带来新的药物治疗方法，并更好地理解冷漠与功能状态之间的关系。