Optimization, Expansion & Validation of Alzheimers Lymphocyte Proliferation Test

描述(由申请人提供)：在GW医疗技术公司的第一阶段工作中，该公司证明了LymProTM(淋巴细胞增殖)测试作为阿尔茨海默病血液测试的可行性。然而，在该测试能够在临床环境中使用之前，仍然需要做大量的工作来充分证明LymPro的能力并确定其局限性。在这项拟议的努力中，GW Medical通过一系列非临床和临床研究，寻求这些剩余问题的答案，并为FDA适用研究准备测试。非临床研究包括时间和剂量反应、受试者内部纵向变异性、样本稳定性和测试重复性。在其临床研究中，该公司将把该测试的应用范围扩大到更广泛的其他慢性、进展性、非阿尔茨海默氏症，并通过在临床诊断失明的情况下进行阿尔茨海默病状态确定来验证该测试的性能。 拟议的第二阶段工作旨在优化、扩展和验证LymPro测试作为阿尔茨海默病诊断测试的性能，并为FDA的适用研究准备该测试。如果得到证实，一种易于管理的阿尔茨海默病测试可以改善每年40多万被诊断为阿尔茨海默病的美国人的生活质量，并通过提供更准确、更及时的诊断来帮助减少与该疾病相关的每年1000亿美元的成本。

DESCRIPTION (provided by applicant): In GW Medical Technologies' Phase I effort, the company demonstrated the LymProTM (lymphocyte proliferation) Test's feasibility as a blood test for Alzheimer's disease. However, much work still needs to be done to fully prove the LymPro's capabilities and define its limitation before the Test can be useful in a clinical environment. In this proposed effort, GW Medical seeks the answers to those residual questions and prepares the Test for FDA applicable studies, through a series of non-clinical and clinical studies. Non-Clinical Studies include time and dose response, intra-subject longitudinal variability, sample stability and Test repeatability. In its clinical study, the company will expand the test's application to a broader variety of other, chronic, progressive, non-Alzheimer's dementia and validate the Test's performance by making Alzheimer's disease status determinations while blinded to the clinical diagnosis. The proposed Phase II effort aims to optimize, expand and validate the LymPro Test's performance as a diagnostic test for Alzheimer's disease and prepare the Test for FDA applicable studies. If proven, an easily administered test for Alzheimer's disease can improve the quality of life for the 400,000 plus Americans who are diagnosed with Alzheimer's disease each year and help reduce the $100 billion in annual costs associated with the disease by providing a more accurate and timely diagnosis.