The Role of Amyloid Beta in the Progression of Cognitive Impairment in PD: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Cortical Amyloid Beta plaques
研究概览
简要总结
The investigators propose to study persons with Parkinson Disease (PD) with detailed clinical, cognitive and imaging at the time of study entry and repeat these assessments 2 years later. The study looks at how changes in activity of the neurotransmitter acetylcholine relates to changes in cognitive function and to see if there is presence or build up of amyloid protein.
详细描述
Participants with PD will be studied at initial visit assessing clinical, cognitive, and brain imaging. A one year and, if applicable, three year cognitive assessment will be done, and the entire/complete assessment (same as initial visit) will be repeated again at two years. There will be a maximum of three follow up visits. The imaging test battery will consist of amyloid and acetylcholine brain PET and MRI scans. The use of acetylcholine PET imaging will demonstrate how changes in activity of this neurotransmitter relate to changes in cognitive functions, such as memory and mental concentration. A key question will be whether persons with PD who not only are losing acetylcholine brain cells but also have the buildup of the Alzheimer amyloid protein have a more rapid progression with more severe cognitive decline and behavioral changes compared to persons who do not have the amyloid protein.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 99 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PD diagnosis according to the UK PD Society of Brain Bank research Center criteria PD subjects at risk for dementia Age 50 and above, male or female Absence of dementia confirmed by clinical and detailed neurological assessment -
排除标准
- •Subjects with contra-indications to MR imaging Evidence of large vessel stroke or mass on on MRI Use of cholinergic or neuroleptic drugs at baseline Evidence of atypical parkinsonism on neurological exam Subjects limited by participation in research procedures involving ionizing radiation Pregnancy(test within 48 hours of each PET session) or breastfeeding
结局指标
主要结局
Cortical Amyloid Beta plaques
时间窗: Change from Baseline in beta-amyloid deposition at 2 years
PIB PET scan
Cognitive function
时间窗: Change from Baseline in cognitive function at 2 years
Detailed neuropsychological test battery
Cholinergic innervation
时间窗: Change from Baseline in cholinergic innervation at 2 years
FEOBV PET scan
次要结局
未报告次要终点
研究者
Nicolaas Bohnen, MD, PhD
Professor of Radiology and Neurology
University of Michigan