Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Olfactory testing
研究概览
简要总结
The overarching goal of this prospective cohort study is to test the hypotheses that greater severity of hyposmia is associated with increased risk of cognitive decline in PD and that worsening hyposmia parallels progressive cholinergic limbic denervation. To achieve the goals of this project, patients with PD without dementia or at-risk of dementia or with dementia will undergo longitudinal olfactory, cognitive and clinical testing for 2-4 years. AChE [11C]PMP or VAchT (vesicular acetylcholine transporter) [F18]-FEOBV PET will be performed both at study entry and at 2-years (± 6 months) follow-up. Brain MRI scans will also be performed at study entry and at 2-years (± 6 months) follow-up. Brain Beta-amyloid PET will be performed at study entry or at 2 years (± 6 months). Annual olfactory testing will be performed to better understand dynamic changes underlying the clinical and PET outcome measures.
详细描述
Smell functions will be assessed using a test battery of odor identification, odor memory, and odor discrimination tests.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with Parkinson disease
- •Hoehn & Yahr stage 2 and higher, and/or duration of motor disease 5 years or longer
- •50 and older
排除标准
- •other disorders which may resemble PD
- •subjects with definite dementia
- •subjects with unstable or severe medical disorders
- •subjects receiving neuroleptic, anticholinergic, or cholinesterase inhibitor drugs
- •subjects in whom MRI imaging is contraindicated
- •subjects who have received ionizing radiation that would, together with the current project exposures, exceed exposure limits permissible to research volunteers
结局指标
主要结局
Olfactory testing
时间窗: Yearly follow up visits
次要结局
未报告次要终点
研究者
Nicolaas Bohnen, MD, PhD
Professor
University of Michigan
