Returning Research Results That Indicate Risk of Alzheimer Disease Dementia to Healthy Participants in Longitudinal Studies: Quantitative Analyses of a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Change in Geriatric Depression Scale (GDS)
研究概览
简要总结
This is a study to evaluate the impact of returning research results that indicate a five-year risk estimate of Alzheimer disease dementia to participants without memory or thinking problems of the Knight Alzheimer Disease Research Center at Washington University in St. Louis.
详细描述
All participants without memory or thinking problems in a longitudinal observational cohort of aging (Memory and Aging Project) will be offered a five-year Alzheimer dementia risk estimate report that incorporates genetic and either neuroimaging research results or plasma amyloid results as well as demographic information into five-year Alzheimer disease dementia risk estimate. Using a two-year delayed-start randomized clinical trial design, participants will be randomized to receive research results either two weeks (Arm A/C) or one year (Arm B/D) after informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current Knight ADRC participants who had their clinical assessment in the previous year.
- •Minimum age of 65 years old
- •Participant must be classified as cognitively normal (CDR® = 0) at their last clinical assessment.
- •Participant has either recent research brain MRI and amyloid PET scan results, or recent plasma amyloid measurements (ideally within the past two years, but up to five years will be acceptable due to COVID-19-related delays).
- •Participant has genetic research results available including APOE status.
- •Participant is currently consented to be contacted for other research opportunities through the Knight ADRC.
排除标准
- •There are no exclusion criteria, other than not meeting all of the inclusion criteria listed above.
研究组 & 干预措施
Arm A
Participants randomized to Arm A will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm A is a neuroimaging arm.
干预措施: Arm A , Arm B, Arm C, & Arm D (Other)
Arm B
Participants randomized to Arm B will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm B is a neuroimaging arm.
干预措施: Arm A , Arm B, Arm C, & Arm D (Other)
Arm C
Participants randomized to Arm C will receive their research results two weeks after they review educational materials provided by the study and sign the informed consent document. Arm C is a plasma amyloid arm.
干预措施: Arm A , Arm B, Arm C, & Arm D (Other)
Arm D
Participants randomized to Arm D will receive their research results one year after they review the educational materials provided by the study and sign the informed consent document. Arm D is a plasma amyloid arm.
干预措施: Arm A , Arm B, Arm C, & Arm D (Other)
结局指标
主要结局
Change in Geriatric Depression Scale (GDS)
时间窗: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial. GDS is also measured at the time of informed consent.
GDS is a questionnaire that screens for depression in older adults. It's a self-report tool that asks yes or no questions about how a person has been feeling over the past week.
Change in Clinical Dementia Rating sum of box score (CDR-SB)
时间窗: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.
Subjective measure of dementia determined as part of clinical assessment.
Change in cognitive composite score
时间窗: Based on parent study timeline. Measures are taken 12 months apart and straddle enrollment in trial.
Objective measure of cognitive functioning.
次要结局
- Decision Regret Scale(2, 6, 12 and 24 months post-disclosure of risk estimate.)
- Impact of Events Scale Revised (IES-R)(2, 6, 12 and 24 months post-disclosure of risk estimate.)
- Modified Social Impact Scale(2, 6, 12 and 24 months post-disclosure of risk estimate.)
- Views Regarding Research(At consent, 6 and 12 months post-disclosure of risk estimate.)
- Self- Report Heath Care Utilization(At consent, 6, 12 and 24 months post-disclosure of risk estimate)
- Understanding of Research Results(2, 12 and 24 months post-disclosure of risk estimate.)
- Lifestyle/Health Behavior Change(6, 12 and 24 months post-disclosure of risk estimate.)
- AD-Related Distress(At consent, 2, 6, 12 and 24 months post-disclosure of risk estimate.)
- Patient Assessment of Communication Effectiveness(2 months post-disclosure of risk estimate.)
- Future Time Perspective(At consent, 12 and 24 months post-disclosure of risk estimate.)