Emory University PD Neuroprotecion Clinical Trail Center

埃默里大学 PD 神经保护临床试验中心

• 批准号: 8460668
• 负责人: JORGE L JUNCOS
• 金额: $ 9.25万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-05-17 至 2015-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8460668
• 关键词: Activities of Daily Living; Address; Adverse event; Cardiac; Caring; Chronic; Clinical; Communication; Creatine; Critiques; Data; Digit structure; Disease; Dose; England; Enrollment; Ensure; Equilibrium; Evaluation; Goals; Health; Health Services; Hospitalization; Individual; Laboratories; Lead; Levodopa; Maintenance; Measures; Medical; Mental Depression; Modality; Monitor; Motor; Neurologist; Outcome Measure; Parkinson Disease; Participant; Patient Care; Patients; Pharmaceutical Preparations; Physicians; Placebo Effect; Placebos; Principal Investigator; Protocols documentation; Publishing; Quality of life; Renal function; Research; Safety; Serious Adverse Event; Serum; Signal Transduction; Site; Study Section; Symptoms; Syncopal Episodes; Testing; Therapeutic Equivalency; Universities; Update; Visit; Weight Gain; Welts; Work; Writing; base; cognitive function; disability; follow-up; illness length; meetings; novel; operation; primary outcome; public health relevance; screening

DESCRIPTION (provided by applicant): At the Emory site we have enrolled 52 subjects and have had no major adverse events (AEs). Please refer to the breakdown at the end of this document for details of this breakdown. After focusing on recruitment, our efforts have been on retention and compliance. For this we have integrated research visits and patient care visits to better monitor safety, make outcome measures and to enhance patient convenience and thus retention into a very long study. Most of the subjects are followed clinically at Emory which has helped retention. For that 20% that are followed elsewhere, or by physicians at Emory other than Dr. Juncos and Freeman, consistent communication with referring physicians has been key to promoting referrals and retention. Brief notes were forwarded to POPs or referring neurologist as laboratory abnormalities were detected, or there was a perceived need to make changes in PD medications or in other medications. This effort continues to work with excellent retention. Of the 52 subjects above, 1 failed screening, 1 died of unrelated and chronic cardiac causes, 2 were lost to follow-up, 2 withdrew from the study due to unrelated medical problems and failing health. These are the totals for the duration of the study with 46 remaining in the study at this site. All are SAEs have been unrelated to participation in the study. The two salient ones this year are: 1) A young onset PD subject had an unexplained syncopal episode followed by a negative work up. He continues to do well and is followed by an outside cardiologists; 2) After stopping use of creatine, a second subject had a planned research hospitalization. Although no longer in the study, he is followed periodically by us as stipulated in the protocol. Other patient continue to participate without major complaints.

描述（由申请人提供）：在Emory研究中心，我们入组了52例受试者，未发生重大不良事件（AE）。请参阅本文件结尾的分项数字，以了解有关分项数字的详情。在专注于招聘之后，我们一直致力于留住员工和合规。为此，我们整合了研究访视和患者护理访视，以更好地监测安全性，制定结局指标，并提高患者便利性，从而保留长期研究。大多数受试者在埃默里大学接受临床随访，这有助于保持记忆。对于在其他地方或由埃默里大学除容科斯博士和弗里曼博士以外的医生随访的20%，与转诊医生的持续沟通是促进转诊和保留的关键。当检测到实验室异常或认为需要改变PD药物或其他药物时，将简要记录转发给POP或转诊神经科医生。这一努力继续与出色的保留工作。在上述52例受试者中，1例筛选失败，1例死于无关和慢性心脏原因，2例失访，2例因无关医学问题和健康状况恶化退出研究。这些是研究期间的总数，该研究中心的研究中剩余46例。所有SAE均与参与研究无关。今年的两个突出的是：1）一个年轻的发病PD受试者有一个原因不明的晕厥发作，随后负工作了。他继续保持良好状态，并由外部心脏病专家随访; 2）停止使用肌酸后，第二例受试者计划进行研究住院治疗。虽然他不再参与研究，但我们按照方案规定定期随访他。其他患者继续参与研究，无重大投诉。