跳至主要内容
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2010年8月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Parkinson's Disease
发起方
University of Michigan
入组人数
74
试验地点
1
主要终点
Olfactory testing
状态
已完成
最后更新
8年前

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.

注册库
clinicaltrials.gov
开始日期
2010年8月
结束日期
2016年7月
最后更新
8年前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

Nicolaas Bohnen, MD, PhD

Professor

University of Michigan

入排标准

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

研究点 (1)

Loading locations...

相似试验