Reactions to Learning Amyloid and Tau Results in Adults at Risk for Alzheimer's Dementia
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Score
研究概览
简要总结
This is a prospective, single-cohort, single-center, observational study to assess if learning one's Alzheimer's disease biomarker test result impacts longitudinal psychosocial, behavioral, and neuropsychological outcomes, and to identify factors that moderate and mediate these outcomes. Participants enrolled in this study are requested to complete surveys at four timepoints after learning their Alzheimer's biomarker test results.
详细描述
The overall objective is to determine how learning one's amyloid and tau test results impacts longitudinal psychosocial, behavioral, and neuropsychological outcomes, and identify factors that moderate and mediate these outcomes.
The rationale is that by understanding factors that explain variability in reactions, biomarker communication and post-testing support can be tailored to optimize outcomes.
The central hypothesis is that learning biomarker profile will affect psychosocial, behavioral, and neuropsychological outcomes, and that these outcomes will be moderated by social determinants of health (SDOH) and perceived communication factors and mediated by illness perceptions and beliefs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing to provide informed consent.
- •Willing to comply with all study procedures and be available for the duration of the study.
- •Individuals at least 45 years of age.
- •Enrolled in Wisconsin Registry for Alzheimer's Prevention (WRAP) or Alzheimer's Disease Research Center Clinical Core (ADRC)
- •Previously adjudicated as cognitively unimpaired having mild cognitive impairment (MCI), or impaired but do not meet diagnostic criteria for mild cognitive impairment or dementia (classified as "Impaired-Not MCI" by the WRAP and ADRC cohorts) at their last WRAP or ADRC study visit at the time of enrollment into this study
- •Have completed or able to complete amyloid and/or tau PET scans as part of a UW Alzheimer's Research Study
排除标准
- •Diagnosis of dementia at the time of enrollment as determined by the most recent parent WRAP/ADRC study visit diagnostic consensus conference using standard NIA-AA 2011 diagnostic criteria. Participants who develop dementia after enrolling into this study may remain enrolled if they maintain decisional capacity and are able to follow study instructions and procedures.
- •Individuals who lack decisional capacity to provide informed consent as determined by significant difficulty in understanding materials and information about study procedures during recruitment and/or informed consent discussions.
- •Not suitable for study participation due to other reasons at the discretion of the investigators.
研究组 & 干预措施
Participants from UW Alzheimer's Disease Research
Participants aged 50-89 who are cognitively unimpaired or have mild cognitive impairment will be enrolled from the Wisconsin Registry for Alzheimer's Prevention, Wisconsin Alzheimer's Disease Research Center Clinical Core, or other studies affiliated with the UW Alzheimer's Research Program.
干预措施: Follow-up Assessments (Other)
Participants from UW Alzheimer's Disease Research
Participants aged 50-89 who are cognitively unimpaired or have mild cognitive impairment will be enrolled from the Wisconsin Registry for Alzheimer's Prevention, Wisconsin Alzheimer's Disease Research Center Clinical Core, or other studies affiliated with the UW Alzheimer's Research Program.
干预措施: Disclose amyloid, tau results (Other)
结局指标
主要结局
Impact of Neuroimaging in Alzheimer's Disease (INI-AD) Score
时间窗: 1 month, 6 months, 12 months, 18 months
Test-related distress will be assessed using the INI-AD instrument. Score range from 0-80 where higher scores indicate increased negative impact of test.
Stigma Impact Scale (SIS) Score
时间窗: 1 month, 6 months, 12 months, 18 months
Items are rated on a 4-point Likert scale ranging from strongly agree (4) to strongly disagree (1), and a fifth option of "not applicable" with higher total scores (24-96) indicating higher perceived stigma.
Control, Autonomy, Self-Realization, and Pleasure (CASP-12)
时间窗: baseline, 1 month, 6 months, 12 months, 18 months
This is a quality of life measure scored from 0-36 where higher scores mean better quality of life.
Future Time Perspective Scale
时间窗: baseline, 1 month, 6 months, 12 months, 18 months
Scores are from 1-7 where higher scores indicate higher engagement.
次要结局
- Exercise Vital Sign Tool: Minutes per Week of Moderate or Vigorous Exercise(baseline, 1 month, 6 months, 12 months, 18 months)
- Willingness to Prevent AD(baseline, 1 month, 6 months, 12 months, 18 months)
- Willingness to Prevent AD: Over the counter, prescription, clinical trial items(baseline, 1 month, 6 months, 12 months, 18 months)
- Cognitive & Leisure Activity Scale (CLAS)(baseline, 1 month, 6 months, 12 months, 18 months)
- 6-item questionnaire for Mediterranean diet(baseline, 1 month, 6 months, 12 months, 18 months)
- Brief Pittsburgh Sleep Quality Index (B-PSQI)(baseline, 1 month, 6 months, 12 months, 18 months)
- Communication Assessment Tool (CAT) Score(1 month)
- Number of Participants who Complete Advanced Directives(baseline, 1 month, 6 months, 12 months, 18 months)
- Clinical Trial Enrollment(baseline, 1 month, 6 months, 12 months, 18 months)