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临床试验/NCT01572142
NCT01572142已完成不适用

Hyposmia, Cholinergic Denervation and Incipient Cognitive Decline in PD

University of Michigan1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2010年8月最近更新:
适应症

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolaas Bohnen, MD, PhD

Professor

University of Michigan

研究点 (1)

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