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【文摘发布】NIH Announces Phase III Clinical Trial of Creatine for Parkinson's Disease

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For release: Thursday, March 22, 2007

The NIH National Institute of Neurological Disorders and Stroke (NINDS) today is launching a large-scale clinical trial to learn if the nutritional supplement creatine can slow the progression of Parkinson's disease (PD). While creatine is not an approved therapy for PD or any other condition, it is widely thought to improve exercise performance. The potential benefit of creatine for PD was identified by Parkinson’s researchers through a new rapid method for screening potential compounds.

The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. It will enroll 1720 people with early-stage PD at 51 medical centers in the United States and Canada.

"This study is an important step toward developing a therapy that could change the course of this devastating disease," says Elias A. Zerhouni, M.D., director of the NIH. "The goal is to improve the quality of life for people with Parkinson's for a longer period of time than is possible with existing therapies." Currently there is no treatment that has been shown to slow the progression of PD.

The trial is the first large study in a series of NINDS-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson's Disease). NINDS has organized this large network of sites to allow researchers to work with PD patients over a long period of time, with a goal of finding effective and lasting treatments. NET-PD builds on a developmental research process—from laboratory research to pilot studies in a select group of patients, to the definitive phase III trial of effectiveness in people with Parkinson’s disease.

"This study is an example of the Institute's commitment to Parkinson's research," says NINDS director Story C. Landis, Ph.D. "We are trying to explore every possible option for reducing the burden of this disease."

Participants will be in the phase III study for five to seven years. The effort will be led by Karl Kieburtz, M.D., M.P.H., of the University of Rochester in New York, and Barbara C. Tilley, Ph.D., of the Medical University of South Carolina in Charleston, and the patients will be seen by movement disorders specialists at the NET-PD sites across the United States and Canada.

PD is a degenerative disorder of the brain in which patients develop symptoms such as progressive tremor, slowness of movements, and stiffness of muscles. It affects at least one million people in the United States. Although certain drugs, such as levodopa, can reduce the symptoms of PD, there are no proven treatments that can slow the progressive deterioration in function.

Creatine is marketed as a nutritional supplement. Studies have suggested that it can improve the function of mitochondria, which produce energy inside cells. It also may act as an antioxidant that prevents damage from compounds that are harmful to cells in the brain. In a mouse model of PD, creatine is able to prevent loss of the cells that are typically affected.

"Creatine, or any compound that may slow the progression of PD, could have very important long-term benefits for people who are living with this disease," says John R. Marler, M.D., NINDS associate director for clinical trials.

The study will enroll people who have been diagnosed with PD within the past five years and who have been treated for two years or less with levodopa or other drugs that increase the levels of dopamine in the brain. Many of the symptoms of PD result from the loss of dopamine, a neurotransmitter that helps to control movement. Half of the participants will receive creatine and half will receive a placebo. Neither the participants nor their doctors will know which treatment they receive.

"We are studying a stage of the disease that usually hasn't been included in clinical studies," notes Dr. Kieburtz. The study is designed to include a broad range of people, with special efforts to recruit a diverse population that is similar to the makeup of the population with PD in the United States.

The investigators will measure disease progression using standard rating scales that measure quality of life, ability to walk, cognitive function, and the ability to carry out other activities of daily living.

Avicena Group, Inc. will provide the creatine and the placebo for the study

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2007-05-12 16:23 浏览 : 737 回复 : 6

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• 且亭读医笔记：进展性脑卒中

sun254

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我认领啦，如果48小时内没有译出，请其他战友自由认领，谢谢

2007-05-12 16:52

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or release: Thursday, March 22, 2007
2007年3月22日星期四发表

消息来源：美国健康研究院官方网站
http://www.nih.gov/news/pr/mar2007/ninds-22.htm

The NIH National Institute of Neurological Disorders and Stroke (NINDS) today is launching a large-scale clinical trial to learn if the nutritional supplement creatine can slow the progression of Parkinson's disease (PD). While creatine is not an approved therapy for PD or any other condition, it is widely thought to improve exercise performance. The potential benefit of creatine for PD was identified by Parkinson’s researchers through a new rapid method for screening potential compounds. 今天美国健康研究院国立神经病及中风研究所启动了一个大型的临床试验验证是否营养补充肌酸可以减缓帕金森病的进程。虽然在任何条件下肌酸都不被大家认可的治疗药物，但是当前普遍认为肌酸可以改善运动能力。帕金森病研究者通过一种快速的方法筛选可能的复合物，来明确肌酸对帕金森病的潜在的好处。

The double-blind, placebo-controlled, phase III study is one of the largest PD clinical trials to date. It will enroll 1720 people with early-stage PD at 51 medical centers in the United States and Canada. 到目前为止，双盲、安慰剂对照和三期临床是帕金森最大的临床试验。有51个美国和加拿大医学中心的1720个帕早期金森患者入选。

"This study is an important step toward developing a therapy that could change the course of this devastating disease," says Elias A. Zerhouni, M.D., director of the NIH. "The goal is to improve the quality of life for people with Parkinson's for a longer period of time than is possible with existing therapies." Currently there is no treatment that has been shown to slow the progression of PD. 美国健康研究院的主任，医学博士Elias A. Zerhouni说，这个研究是改变这种破坏性疾病的病程和建立一个治疗方法的重要步骤。目的是改善长期患有帕金森的患者在现存治疗手段的生活质量。目前还没有一种有效的治疗可以延缓帕金森病的进程。

The trial is the first large study in a series of NINDS-sponsored clinical trials called NET-PD (NIH Exploratory Trials in Parkinson's Disease). NINDS has organized this large network of sites to allow researchers to work with PD patients over a long period of time, with a goal of finding effective and lasting treatments. NET-PD builds on a developmental research process—from laboratory research to pilot studies in a select group of patients, to the definitive phase III trial of effectiveness in people with Parkinson’s disease. 这个研究是国立神经病及中风研究所组织的一组临床试验中的一个，称为NET-PD （美国健康研究院帕金森病探索性试验）。国立神经病及中风研究所组织这个大型的网络结构，是研究者可以对帕金森患者进行长期的治疗，目标是找到有效和持久地治疗方法。美国健康研究院帕金森病探索性试验希望建立一个发展性的研究过程，从实验室研究到选择一组人进行初步研究，确定帕金森患者的三期临床的有效性。

"This study is an example of the Institute's commitment to Parkinson's research," says NINDS director Story C. Landis, Ph.D. "We are trying to explore every possible option for reducing the burden of this disease." 国立神经病及中风研究所的主任，医学博士Story C. Landis说，这个研究是学院委托研究的例子，我们尽量探索每一个可能减小这个疾病的机会。
Participants will be in the phase III study for five to seven years. The effort will be led by Karl Kieburtz, M.D., M.P.H., of the University of Rochester in New York, and Barbara C. Tilley, Ph.D., of the Medical University of South Carolina in Charleston, and the patients will be seen by movement disorders specialists at the NET-PD sites across the United States and Canada. 参加者会进行5-7年的三期临床研究。纽约大学的公共卫生硕士，医学博士Rochester Karl Kieburtz和南卡罗来纳医科大学的哲学硕士Barbara C. Tilley来进行这项工作，美国和加拿大的美国健康研究院帕金森病探索性试验点的患者由运动失调专家护理。

PD is a degenerative disorder of the brain in which patients develop symptoms such as progressive tremor, slowness of movements, and stiffness of muscles. It affects at least one million people in the United States. Although certain drugs, such as levodopa, can reduce the symptoms of PD, there are no proven treatments that can slow the progressive deterioration in function. 帕金森病是大脑退行性功能紊乱，患者可以发展为进行性加重的振颤、活动缓慢和四肢肌肉僵硬。在美国至少有一百万患者。虽然一定的药物如左旋多巴，可以减少帕金森病的症状，但是没有证据表明治疗可以减缓功能性恶化的进程。

Creatine is marketed as a nutritional supplement. Studies have suggested that it can improve the function of mitochondria, which produce energy inside cells. It also may act as an antioxidant that prevents damage from compounds that are harmful to cells in the brain. In a mouse model of PD, creatine is able to prevent loss of the cells that are typically affected. 肌酸被当作营养支持物销售。研究显示肌酸可以改善线粒体功能，在细胞内产生能量。他也可以作为氧化剂阻止化合物对大脑细胞的氧化损害。在小鼠的帕金森模型，肌酸可以通过典型的作用阻止细胞损失。

"Creatine, or any compound that may slow the progression of PD, could have very important long-term benefits for people who are living with this disease," says John R. Marler, M.D., NINDS associate director for clinical trials. 国立神经病及中风研究所这项研究的副主任，医学博士John R. Marler说，肌酸或者其他任何可以减缓帕金森病进程的化合物，可以对帕金森病患者的有长期、大量的益处。

The study will enroll people who have been diagnosed with PD within the past five years and who have been treated for two years or less with levodopa or other drugs that increase the levels of dopamine in the brain. Many of the symptoms of PD result from the loss of dopamine, a neurotransmitter that helps to control movement. Half of the participants will receive creatine and half will receive a placebo. Neither the participants nor their doctors will know which treatment they receive. 这项研究受试者的入选标准是：在过去5年被诊断为帕金森病，并且左旋多巴或其他药物治疗两年或两年以内，大脑内多巴胺事平生高。帕金森患者的症状是由，一种帮助控制行为的递质，多巴胺损耗。一半的患者使用肌酸，一半的患者使用安慰剂，受试者和医生都不知道他们接受的是哪一种治疗。

"We are studying a stage of the disease that usually hasn't been included in clinical studies," notes Dr. Kieburtz. The study is designed to include a broad range of people, with special efforts to recruit a diverse population that is similar to the makeup of the population with PD in the United States. Dr. Kieburtz写道，我们研究疾病的一个时期经常不包括临床研究。这个研究包括广泛的人群，专业的工作招募了美国与帕金森病相似的人群。

The investigators will measure disease progression using standard rating scales that measure quality of life, ability to walk, cognitive function, and the ability to carry out other activities of daily living. 这个调查测量帕金森病的进程采用等级评定量表评定生命的质量、行走的能力、认知功能和实现日常生活活动的能力。

Avicena Group, Inc. will provide the creatine and the placebo for the study。Avicena Group公司提供研究用的肌酸和安慰剂。

2007-05-14 17:43

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sun254 编辑于 2007-05-15 15:20

• 考研初试成绩即将公布，你有什么想说的？

sun254

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2007年3月22日星期四发表于美国健康研究院官方网站
美国健康研究院宣布进行肌酸对帕金森病的Ⅲ期临床试验
今天美国健康研究院国立神经病及中风研究所启动了一个大型的临床试验验证是否营养补充肌酸可以减缓帕金森病的进程。虽然在任何条件下肌酸都不被大家认可的治疗药物，但是当前普遍认为肌酸可以改善运动能力。帕金森病研究者通过一种快速的方法筛选可能的复合物，来明确肌酸对帕金森病的潜在的好处。
到目前为止，这个安慰剂双盲对照的三期临床是帕金森最大的临床试验。有51个美国和加拿大医学中心的1720个帕早期金森患者入选。
美国健康研究院的主任，医学博士Elias A. Zerhouni说，这个研究是改变这种破坏性疾病的病程和建立一个治疗方法的重要步骤。目的是改善长期患有帕金森的患者在现存治疗手段的生活质量。目前还没有一种有效的治疗可以延缓帕金森病的进程。
这个研究是国立神经病及中风研究所组织的一组临床试验中的一个，称为NET-PD （美国健康研究院帕金森病探索性试验）。国立神经病及中风研究所组织这个大型的网络结构，是研究者可以对帕金森患者进行长期的治疗，目标是找到有效和持久地治疗方法。
美国健康研究院帕金森病探索性试验希望建立一个发展性的研究过程，从实验室研究到选择一组人进行初步研究，确定帕金森患者的三期临床的有效性。国立神经病及中风研究所的主任，医学博士Story C. Landis说，这个研究是学院委托研究的例子，我们尽量探索每一个可能减小这个疾病的机会。参加者会进行5-7年的三期临床研究。
纽约大学的公共卫生硕士，医学博士Rochester Karl Kieburtz和南卡罗来纳医科大学的哲学硕士Barbara C. Tilley来进行这项工作，美国和加拿大的美国健康研究院帕金森病探索性试验点的患者由运动失调专家护理。
帕金森病是大脑退行性功能紊乱，患者可以发展为进行性加重的振颤、活动缓慢和四肢肌肉僵硬。在美国至少有一百万患者。虽然一定的药物如左旋多巴，可以减少帕金森病的症状，但是没有证据表明治疗可以减缓功能性恶化的进程。
肌酸被当作营养支持物销售。研究显示肌酸可以改善线粒体功能，在细胞内产生能量。他也可以作为氧化剂阻止化合物对大脑细胞的氧化损害。在小鼠的帕金森模型，肌酸可以通过典型的作用阻止细胞损失。
国立神经病及中风研究所这项研究的副主任，医学博士John R. Marler说，肌酸或者其他任何可以减缓帕金森病进程的化合物，可以对帕金森病患者的有长期、大量的益处。这项研究受试者的入选标准是：在过去5年被诊断为帕金森病，并且左旋多巴或其他药物治疗两年或两年以内，大脑内多巴胺事平生高。
帕金森患者的症状是由，一种帮助控制行为的递质，多巴胺损耗导致的。一半的患者使用肌酸，一半的患者使用安慰剂，受试者和医生都不知道他们接受的是哪一种治疗。
Dr. Kieburtz写道，我们研究疾病的一个时期经常不包括临床研究。这个研究包括广泛的人群，专业的工作招募了美国与帕金森病相似的人群。
这个调查测量帕金森病的进程采用等级评定量表评定生命的质量、行走的能力、认知功能和实现日常生活活动的能力。
Avicena Group公司提供研究用的肌酸和安慰剂。

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2007-05-14 21:01

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sun254 编辑于 2007-05-15 15:32

• 三脑室占位，MR平扫+增强，有病理结果（一周后公布病理）

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