Genetic Risk Assessment and Counseling for Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 5
- 主要终点
- Center for Epidemiological Studies-Depression Scale (CES-D)
研究概览
简要总结
The purpose of this study is to determine the characteristics of those who obtain genetic susceptibility testing for Alzheimer's disease with APOE disclosure and to study the psychological and behavioral consequences of providing this information.
详细描述
Advances in genetic research have led to an increased number of testing procedures to determine future risk of disease among at-risk individuals. An increasing number of genes are being identified that confer susceptibility for a given disease rather than inevitably causing it. Given that such genes may provide risk information for common diseases (e.g., stroke, depression), there is a growing need to understand how at-risk populations might respond to the option of genetic susceptibility testing. A prominent case in point is Alzheimer's disease (AD).
Participation in this study requires an initial phone call which will elicit some medical and family history information about the participant. A first in-person visit to the clinic will consist of an education session and the administration of some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Approximately 2 weeks later, participants will return to have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the experimental arm will receive information on their risk based on their family history and APOE genotype, while those in the active comparator arm will receive information on their risk for developing Alzheimer's disease based on their family history alone. Participants will be followed for 1 year following disclosure of results with 2 additional clinic visits.
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
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult children of a person with clinically diagnosed and/or autopsy-confirmed Alzheimer's disease
- •18 years or older
排除标准
- •Current dementia
- •Current untreated depression
结局指标
主要结局
Center for Epidemiological Studies-Depression Scale (CES-D)
时间窗: baseline, 6 weeks, 6 months, 12 months post-disclosure
Beck Anxiety Inventory (BAI)
时间窗: baseline, 6 weeks, 6 months, 12 months post-disclosure
次要结局
- Impact of Events Scale (IES)(6 weeks, 6 months, 12 months post-disclosure)
- Future Attitudes Scale (FAS)(baseline, 6 weeks, 6 months, 12 months post-disclosure)
- Positive and Negative Affect Schedule (PANAS)(baseline, 6 weeks, 6 months, 12 months post-disclosure)
