Optimization, Expansion & Validation of Alzheimers Lymphocyte Proliferation Test

描述（由申请人提供）：在GW医疗技术的I期工作中，该公司证明了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，在临床环境中使用lypro之前，还需要做很多工作来充分证明其能力并确定其局限性。在这项拟议的努力中，GW Medical寻求这些遗留问题的答案，并通过一系列非临床和临床研究为FDA适用的研究准备测试。非临床研究包括时间和剂量反应、受试者内部纵向变异性、样本稳定性和试验可重复性。在临床研究中，该公司将把该测试的应用范围扩大到更广泛的其他慢性、进行性、非阿尔茨海默氏症痴呆症，并通过在对临床诊断不知情的情况下确定阿尔茨海默病状态来验证该测试的性能。

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.