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临床试验/NCT04756232
NCT04756232已完成早期 1 期

Cholinergic Mechanisms of Attention in Aging

Vanderbilt University Medical Center1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2022年4月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
19
试验地点
1
主要终点
Proportion of participants who complete EEG

研究概览

简要总结

This study will use an anticholinergic pharmacological probe to examine attention network function in SCD using EEG. The overall hypothesis is that in older adults with SCD, normal cognitive performance is maintained by compensatory attention network activity, supported by enhanced cholinergic function. The investigators anticipate that SCD will be associated with greater compensatory attention network activity and that disrupting this compensatory process through anticholinergic challenge will result in a greater negative effect on attentional performance (Attention Network Test, ANT) and attention network functioning (EEG) in older adults with SCD compared to those without SCD.

详细描述

Overview: Cognitively normal older adults with and without subjective cognitive decline (SCD) (n = 20; SCD = 10, Non-SCD = 10) will complete two study visits that will be double blinded and randomized for anticholinergic challenge (mecamylamine/scopolamine or placebo). Drug challenge visits will include cognitive testing and an electroencephalography (EEG) session.

Aim 1: Feasibility of EEG during mecamylamine/scopolamine challenge

The primary outcome measures for Aim 1 will be the rate of completion of study visits with drug challenge and of completion of EEG tasks during the study visits with drug challenge.

Attention Network Test: The attention network test (ANT) is designed to test selective attention , and combines attentional cues with a flanker task. Behavioral measures of the ANT will be 1) Alerting: reaction time (RT) non-cue trials - cue trials; 2) Orienting: RT neutral cue trials - spatial cue trials; 3) Executive: RT incongruent trials - congruent trials.

EEG, Task-related Event Related Potentials: Each participant will complete the ANT during EEG with primary event relation potential (ERP) measures: 1) Alerting: early sensory ERP (P1) amplitude; 2) Orienting: early sensory ERP (P1) amplitude; 3) Executive: target and conflict evaluation ERP (P3) amplitude. Other ERP signals related to attention and sensory processing will be examined in exploratory analyses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Montreal Cognitive Assessment (MoCA) > 25 AND Global Deterioration Scale (GDS) rating < 3
  • Non-smokers

排除标准

  • medical contraindications to the drug challenge
  • primary neurological disorder (such as stroke, epilepsy, etc.)

研究组 & 干预措施

Anticholinergic Challenge

Experimental

All participants will receive oral mecamylamine or IV scopolamine for 1 day

干预措施: Mecamylamine Challenge (Drug)

Placebo Challenge

Placebo Comparator

All participants will receive oral placebo for 1 day

干预措施: Placebo Comparator Challenge (Other)

结局指标

主要结局

Proportion of participants who complete EEG

时间窗: After administration of second drug challenge, approximately 72 hours

Proportion of participants who complete EEG sessions as measured by adminstration of EEG

Proportion of participants who complete study visits with drug challenge

时间窗: After administration of second drug challenge, approximately 72 hours

Proportion of particiapnts who complete study days as measured by study drug administration on both study visits with drug challenge

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

Kimberly Albert

Research Instructor, Psychiatry

Vanderbilt University Medical Center

研究点 (1)

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