SBIR Phase II: Early and Specific Dementia Diagnosis Using Imaging and Pattern Classification Software

这个小企业创新研究（SBIR）二期项目解决了在开发阿尔茨海默病和其他痴呆症的有效治疗方法以及患者治疗中对准确患者诊断的关键需求。痴呆症临床试验中选择的患者的高度可变性，包括误诊，是这些试验高失败率的一个重要因素。这项拨款正在开发的诊断方法将为减少误诊和患者的可变性提供重要途径。第二阶段的主要目标是扩展第一阶段开发的糖代谢痴呆诊断，使其能够分析淀粉样蛋白PET图像和结构磁共振图像（MRI），并将这些成像模式中的一种或多种数据结合起来，形成最佳的诊断和预后评估。该研究将包括开发、改进和测试：识别患者痴呆症类型的单模态分析方法，将患者置于疾病严重程度的单模态分析方法，组合和优化来自多种成像模式的信息的方法，以及进行这些分析的自动化软件。此外，将根据医生和制药合作伙伴的反馈进一步编制和完善报告，以便清楚地传达结果。该项目的更广泛的影响/商业潜力是能够解决实现成功临床试验中患者可变性的主要障碍，从而增加寻找阿尔茨海默病和其他痴呆症有效治疗方法的机会。仅在美国就有超过600万人受到这些痴呆症的影响，社会成本估计超过4000亿美元。随着人口老龄化，这一群体正在迅速增长，迫切需要有效地识别和治疗患者。利用这项技术筛选患者进行临床试验，并对他们进行分层分析，预计对制药公司具有巨大价值，这是一个初步的商业机会。第一阶段的开发已经用于两家这样的公司的项目。准确诊断患者的能力将有助于解决正确治疗这些患者的需求。随着初始服务模式和后续产品模式的实施，该项目将创造就业机会。最后，通过在临床试验中对受试者进行表征，该项目将有助于科学地理解疾病的进展及其与症状和治疗反应的关系。

This Small Business Innovation Research (SBIR) Phase II project addresses a critical need for accurate patient diagnosis in the development of effective therapeutics for Alzheimer's Disease and other dementias, and in patient treatment. The high variability of patients selected for dementia clinical trials, including misdiagnosis, has been a significant contributor to the high failure rates of these trials. The diagnostic under development in this grant would provide an important way to reduce misdiagnosis and patient variability. A main objective of Phase II is to expand the glucose metabolism dementia diagnostic developed in Phase I to be capable of analyzing amyloid PET images and structural magnetic resonance images (MRI), and to combine data from one or more of these imaging modalities into an optimal diagnostic and prognostic assessment. The research will include the development, refinement and testing of: single-modality analysis methods that identify the type of dementia that a patient has, single-modality analysis methods that place the patient along a scale of disease severity, methods that combine and optimize information from multiple imaging modalities, and automated software to conduct these analyses. In addition, reports will be further developed and refined with feedback from physicians and pharmaceutical partners to clearly communicate results.The broader impact/commercial potential of this project is the ability to address a major barrier of patient variability in achieving successful clinical trials, thus increasing the opportunity to find effective therapeutics for Alzheimer's Disease and other dementias. More than 6 million persons in the U.S. alone are affected by these dementias, with a societal cost estimated at more than $400 billion. This population is rapidly growing as the population ages, and the need to effectively identify and treat patients is urgent. The use of the technology to screen patients for clinical trials and stratify them for analysis is expected to be of immense value to pharmaceutical companies and is an initial commercial opportunity. Already, the developments of Phase I are in use for projects with two such companies. The ability to accurately diagnose patients will help to address the need to correctly treat these patients. The project will result in job creation as the initial service model and subsequent product model are implemented. Finally, by allowing characterization of the subjects in clinical trials, this project will aid in the scientific understanding of the progression of disease and its relationship to symptoms and response to therapy.