Development of Cognitive Assessment Tools in Parkinson Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The overall goal of this proposal is to validate ANAM-PD as an assessment tool for cognitive status in PD
研究概览
简要总结
The main objectives of this protocol are as follows:
- To assess the sensitivity and specificity of ANAM-PD in detecting cognitive status in patients with Parkinson disease (PD) and healthy controls (HC).
- To validate the specific individual domains of the ANAM-PD cognitive battery by comparisons to available standardized cognitive evaluation scales administered to the patients with Parkinson disease with and healthy control subjects.
- To evaluate the reliability of the ANAM-PD battery of tests by comparing repeated administrations of the ANAM-PD battery on a sub-set of subjects with Parkinson disease and healthy controls.
- To characterize cholinergic neurotransmission through imaging the vesicular acetylcholine transporter binding with 123Iodobenzovesamicol (IBVM) and SPECT in PD patients and healthy controls.
详细描述
General Design and Methods The overall goal of this proposal is to validate ANAM-PD as an assessment tool for cognitive status in PD. We propose a comprehensive strategy to evaluate the sensitivity and specificity of ANAM-PD in detecting cognitive changes in patients with a diagnosis of PD (n=50) and healthy controls (n=25). The specific testing domains of the ANAM-PD battery will be validated against standardized neuropsychological testing, described in detail below. The reliability of the ANAM-PD battery will be evaluated through a test-retest procedure in a subset of 50 subjects (25 PD and 25 HC). This strategy will enable us to evaluate the individual domains of the ANAM-PD computerized cognitive test and establish a battery as a standard test to efficiently measure cognitive changes in PD. We also propose to explore functional neuroimaging of the cholinergic system using [123I] IBVM and SPECT, a marker of vesicular acetylcholine transporter and a measure of the integrity of the cholinergic neuronal system. Identifying and validating ANAM-PD as an efficient tool for assessing cognitive changes in PD and exploring the cholinergic transporter system in PD through functional neuroimaging could predict sub-sets of PD patients 'at risk' for developing dementia and help elucidate the neurochemistry related to cognitive decline in PD
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
2 cohorts
In this observational study 2 cohorts will participate. Cohort 1 will include people with Parkinson disease and Cohort 2 will include healthy volunteers.
A subset of twelve subjects (8 PD and 4 HC) will be enrolled in the [123I] IBVM and SPECT imaging portion of this study
干预措施: [123I] IBVM and SPECT imaging (Drug)
2 cohorts
In this observational study 2 cohorts will participate. Cohort 1 will include people with Parkinson disease and Cohort 2 will include healthy volunteers.
A subset of twelve subjects (8 PD and 4 HC) will be enrolled in the [123I] IBVM and SPECT imaging portion of this study
干预措施: Subjects will undergo the 123-I IBVM imaging visit (Drug)
结局指标
主要结局
The overall goal of this proposal is to validate ANAM-PD as an assessment tool for cognitive status in PD
时间窗: 6 mos
次要结局
未报告次要终点
研究者
Danna Jennings, MD
Principal Investigator
Institute for Neurodegenerative Disorders