Assessment of the Effect of Treatment Pathways, Adherence, and Treatment Efficacy in Parkinson's Disease Subjects Randomized to SPECT Imaging of the Dopamine Transporter (Ioflupane I123 Injection)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patient adherence to treatment plan
研究概览
简要总结
The purpose of this study is to evaluate the impact of imaging the brain as a diagnostic tool in the management of early Parkinson's disease (PD).
详细描述
The imaging drug used in this study is Ioflupane (123I) Injection, also referred to as DaTscan. DaTscan is FDA approved.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80;
- •diagnosis of idiopathic PD exhibiting at least 2 of 3 cardinal signs (bradykinesia, rigidity and resting tremor);
- •maximum duration of previous exposure to anti-parkinsonian therapy being < 8 weeks;
- •ability to signed informed consent;
- •willingness and ability to complete medication diary and questionnaires;
- •if a female subject of child-bearing potential, the use of an effective method of contraception.
排除标准
- •current treatment with anti-parkinsonian medication;
- •previous treatment with anti-parkinsonian medication for greater than 8 weeks;
- •inability to complete questionnaires;
- •unwillingness to complete all questionnaires and medication diary;
- •subjects with secondary causes of parkinsonism;
- •participant has evidence of clinical significant thyroid disease, gastrointestinal, cardiovascular, hepatic, renal, hematologic, neoplastic, endocrine, neurologic, immunodeficiency, pulmonary, or other medical or psychiatric disorder;
- •positive serum/urine pregnancy test at any time during the study period;
- •the participant has a history of alcohol, narcotic, or any other drug abuse as defined by the DSM-IV within the past 2 years;
- •participation in a concurrent PD trial within 60 days.
结局指标
主要结局
Patient adherence to treatment plan
时间窗: 1 year
Patient and treating physician agree on a treatment plan at visit 3. Patient adherence to medications will be evaluated based on pill count at each follow-up study visit. Additionally, each patient will record their adherence to therapy on the Patient Expectations and Disease-related Questionnaire (PEDQ) at each follow-up study visit, allowing the study team to track compliance with pharmacologic therapy as well as treatments including therapy exercise plans.
次要结局
- Obsessive - Compulsive Inventory (OCI)(1 year)
- Expectation of Global Response (EGCR)(1 year)
- Unified Parkinson Disease Rating Scale (UPDRS)(1 year)
- Life Orientation Test - Revised (LOT-R)(1 year)
- Marlowe - Crowne Social Desirability Scale (MCSD)(1 year)