Parkinson's Disease Neuroprotection Clinical Trial

帕金森病神经保护临床试验

基本信息

批准号：
7759184
负责人：
JOANNE M WOJCIESZEK
金额：
$ 3.33万
依托单位：
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
依托单位国家：
美国
项目类别：
财政年份：
2002
资助国家：
美国
起止时间：
2002-09-30 至 2012-11-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7759184
关键词：
Adherence Adult Advance Directives Advocacy Affinity African American Age Agreement Animals Apomorphine Autoradiography Awareness Back Blood Canada Carbidopa Caring Case Report Form Caucasians Caucasoid Race Certification Chronic Clinic Clinical Clinical Investigator Clinical Protocols Clinical Research Clinical Trials Clinical Trials Cooperative Group Clinical Trials Design Cocaine Code Collaborations Commit Complex Confidentiality Contracts Control Groups Country County Hospitals Data Data Collection Diagnosis Discipline Disease Doctor of Philosophy Dopamine Dose Double-Blind Method Effectiveness Electrocardiogram Enrollment Ensure Environment Enzymes Equipment Evaluation Exclusion Faculty Fellowship Functional Magnetic Resonance Imaging Funding Good Clinical Practice Hospitals Hour Human Huntington Disease Huntington gene Image Image Analysis Indiana Indigent Levodopa Ligands Longitudinal Studies Magnetic Resonance Imaging Maintenance Measures Medex Mesylates Minority Monitor Motor Movement Disorders National Institute of Neurological Disorders and Stroke Neurologist Neurosciences Newly Diagnosed Newsletter Novartis brand of entacapone Nurses Outpatients Parkinson Disease Patient Care Patients Pharmaceutical Preparations Pharmacologic Substance Pharmacy facility Phase Phase II Clinical Trials Phase III Clinical Trials Physicians Pilot Projects Placebo Control Positron-Emission Tomography Primary Health Care Principal Investigator Procedures Process Protocols documentation Quality of Care Randomized Randomized Controlled Trials Recruitment Activity Regulation Reporting Research Research Ethics Committees Research Personnel Resources Risk Rosa Safety Schools Selegiline Serious Adverse Event Services Site Solid Specific qualifier value Staging Support Groups Symptoms System Tablets Therapeutic Thoracic Radiography Time Tomography, Computed, Scanners Training Trust United States Department of Veterans Affairs United States National Institutes of Health Universities University Hospitals Validation Visit Walking Woman Work X-Ray Computed Tomography analog base clinical effect computer generated demographics design dopamine transporter entacapone experience genetic linkage medical schools meetings monoamine nervous system disorder neuroprotection open label optical imaging patient population placebo controlled study programs rasagiline remacemide research facility response serotonin transporter skills symposium tertiary care

项目摘要

DESCRIPTION (provided by applicant): The objective of this multiple center clinical trial will be to determine safety, tolerability and efficacy of one or more agents as neuroprotective therapies for Parkinson's disease (PD). The Movement Disorders Clinic at Indiana University will make a commitment to enroll 84 subjects in three and a half years for the pilot studies (n=12) and for the main clinical trial (n=72). The duration of the study will be 6-8 years. The investigators and the nurse coordinator possess clinical expertise in treating PD and have substantial experience in executing clinical protocols for PD. Recruitment of subjects will be from PD clinics at a tertiary care center and at a country hospital to maximize the potential for encouraging minorities and women to participate in these studies. The agents under study and the final design of the trials have yet to be determined.

描述（由申请人提供）：该多个中心临床试验的目的是确定一种或多种药物作为帕金森氏病（PD）的神经保护疗法的安全性，耐受性和功效。印第安纳大学的运动障碍诊所将承诺在三年半内招募84名受试者进行试点研究（n = 12）和主要的临床试验（n = 72）。该研究的持续时间将为6 - 8年。研究人员和护士协调员在治疗PD方面具有临床专业知识，并且在执行PD的临床方案方面具有丰富的经验。受试者的招募将来自三级护理中心的PD诊所和乡村医院，以最大程度地鼓励少数民族和妇女参加这些研究。正在研究的代理和试验的最终设计尚未确定。