Triage Survey for Neurology Research Eligibility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 3
- 主要终点
- Proportion of the clinical trial seeking population for whom industry-sponsored clinical research is clinically appropriate, as defined as those who go on to screen for a study.
研究概览
简要总结
TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials.
详细描述
TRIAGE-Neuro is a survey study designed to assess potential participants' eligibility to screen for industry-sponsored neurology clinical trials. Secondary objectives include identifying participant characteristics among the clinical trial-seeking population, identifying the percentage of potential participants currently taking prescribed memory medications that could exclude them from clinical trial participation, examining how changes in prescription memory medications impact performance on cognitive assessments, and identifying the percentage of potential participants whose laboratory results could exclude them from clinical trial participation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant and study partner (when applicable) have signed an ICF prior to study-specific procedures being performed.
- •Participant and study partner (when applicable) are at least 18 years old.
排除标准
- •Participant lacks the language skills or cognitive ability to understand the screening process.
- •Participant is pregnant, breast-feeding, or planning to become pregnant.
- •History of a clinically significant illness which in the investigator's opinion may impact participant safety or the ability to analyze study results.
- •Participant represents an acute suicidal risk, as defined as a "yes" response to ideation on Columbia-Suicide Severity Rating Scale questions 4 or 5, or answer "yes" to behavior questions within 90 days of screening.
- •Moderate or severe substance use disorder within 90 days prior to screening, according to DSM-5 criteria that in the investigator's opinion could pose undue risk to the participant.
- •Any condition that in the investigator's opinion makes a participant unsuitable for the study.
- •Currently employed by Adams Clinical or a first-degree relative of an employee working on this study.
结局指标
主要结局
Proportion of the clinical trial seeking population for whom industry-sponsored clinical research is clinically appropriate, as defined as those who go on to screen for a study.
时间窗: Up to 52 weeks
次要结局
- Proportion of the clinical trial seeking population who enroll in industry-sponsored studies.(Up to 52 weeks)
- Change in performance on the Mini Mental Status exam for individuals who discontinue memory medications.(Up to 52 weeks)
- Changes in score on the Neuropsychiatric Inventory Questionnaire for individuals who discontinue memory medications.(Up to 52 weeks)