Pilot Collaborative PET Imaging Trial

描述（由申请人提供）：老年人通常会出现思维问题和令人不安的行为变化，表明轻度痴呆。临床医生面临的挑战是确定症状是由于进行性痴呆疾病，如额颞叶痴呆（FTD）或阿尔茨海默病（AD），还是由于非痴呆性精神疾病。目前用于此类决策的诊断算法是主观的，并且基于临床病史和检查，或者可以观察患者直到结果明显。现在迫切需要实用的、经过验证的诊断性生物标志物，以实现更有效和更具体的治疗。

DESCRIPTION (provided by applicant): Older adults commonly develop thinking problems and disturbing behavior changes suggesting mild dementia. The challenge confronting clinicians is to determine whether symptoms are due to a progressive dementing illness such as frontotemporal dementia (FTD) or Alzheimer's disease (AD), or a non-dementing psychiatric disorder. Current diagnostic algorithms for such decisions are subjective and based on clinical history and examination, or patients can be observed until the outcome is obvious. Practical, validated diagnostic biomarkers now are urgently needed for more effective and specific treatments. Our group has collected preliminary data suggesting positron emission tomography with SF fluorodeoxyglucose (FDG-PET) is a biomarker that can improve the accurate diagnosis of FTD. We propose a 3-year, prospective, multi-center pilot trial to evaluate in a realistic clinical setting the value of FDG-PET when FTD is suspected. A pilot trial rather than a full-scale study is proposed, because many scientific and logistic advances are necessary first. Nine sites will recruit 6 patients with cognitive impairment and behavioral or language symptoms suggestive of FTD. Two dementia specialists will evaluate each patient using standard clinical methods and make a diagnosis before performing an FDG-PET scan. One then will receive the results of this scan and provide clinical care; the other will remain blinded to these results and perform protocol evaluations every 6 months. After 18 months, a consensus panel with access to all of the patient's data, including autopsy findings in some cases, will determine the final diagnosis. The primary hypothesis of the study is that diagnoses after the FDG-PET scan will be significantly more accurate than those before. In addition, we will determine how FDG-PET results affect physician confidence, patient care and caregiver satisfaction. The consensus panel also will review the outcome of 60 previously studied patients. The results of this study will have broad implications for the development of new biomarkers and the use of FDG-PET in the evaluation of AD and other dementias. In addition to its scientific aims, this pilot trial also will evaluate subject selection and consensus panel procedures and uniform image acquisition and quality control methods needed for the large-scale study.