TRIAL OF SIMVASTATIN TO SLOW THE PROGRESSION OF ALZHEIMER'S DISEASE

辛伐他汀减缓阿尔茨海默病进展的试验

• 批准号: 7376557
• 负责人: JUDITH L HEIDEBRINK
• 金额: $ 0.51万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-05 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7376557
• 关键词: Alzheimer' s disease; cholesterol; dementia; memory; placebos; simvastatin; thinking

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Alzheimer's disease (abbreviated AD) is an illness that causes increasing difficulty in the ability to think and remember. The decline of thinking and memory is known as "dementia," and AD is the most common cause of dementia in the U.S. The exact cause of AD is not known. There is some evidence that one way to slow down or help prevent AD may be to lower cholesterol. This research project will study whether a drug called simvastatin, which is an FDA-approved drug commonly used to lower cholesterol, might also help reduce AD symptoms. Approximately 10 participants are expected to be enrolled at this site. There will be 400 participants enrolled in this research study at approximately 40 study sites in the United States. To be enrolled, a person must be 50 years old and above and have a diagnosis of Alzheimer's disease. Medical condition and physical health must be acceptable as determined by medical history, a doctor's examination and laboratory tests. Some people may not be eligible to participate if they are using medications that are not allowed, or if the doctor determines they do not qualify based on their results from a set of cognitive and physical tests. If a person is pregnant or allergic to study medication, they must not participate. People who participate will be randomly assigned to receive simvastatin or a placebo. Randomly means by chance, like flipping a coin. Placebo means an inactive substance, sometimes called a "dummy pill" or "sugar pill." A placebo is not expected to have any effect on AD. Participants will take study medication for 18 months, and will come to the clinic 8 times. During the clinic visits, they will have tests of their thinking and memory, and blood samples will be drawn. Researchers will measure whether there is any difference in thinking and memory skills between people who were on simvastatin compared to people who were on placebo.

该子项目是利用NIH/NCRR资助的中心赠款提供的资源的许多研究子项目之一。子项目和研究者（PI）可能从另一个NIH来源获得主要资金，因此可以在其他CRISP条目中表示。所列机构为中心，不一定是研究者所在机构。阿尔茨海默病（简称AD）是一种导致思考和记忆能力增加困难的疾病。思维和记忆的下降被称为“痴呆症”，AD是美国痴呆症最常见的原因。有一些证据表明，减缓或帮助预防AD的一种方法可能是降低胆固醇。这项研究项目将研究一种名为辛伐他汀的药物，这是一种FDA批准的常用于降低胆固醇的药物，是否也有助于减少AD症状。预计该研究中心将招募约10名参与者。将有400名受试者在美国约40家研究中心入组本研究。要注册，一个人必须年满50岁，并有阿尔茨海默病的诊断。根据病史、医生检查和实验室测试，医疗状况和身体健康必须是可以接受的。有些人可能没有资格参加，如果他们使用的药物是不允许的，或者如果医生确定他们不符合基于他们的结果从一组认知和身体测试。如果受试者妊娠或对研究药物过敏，则不得参与研究。参与者将被随机分配接受辛伐他汀或安慰剂。随机意味着偶然，就像抛硬币一样。安慰剂是指一种非活性物质，有时被称为“假药丸”或“糖丸”。“安慰剂预计对AD没有任何影响。受试者将服用研究药物18个月，并将前往诊所8次。在诊所访问期间，他们将接受思维和记忆测试，并抽取血液样本。研究人员将测量服用辛伐他汀的人与服用安慰剂的人在思维和记忆能力方面是否有任何差异。