Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 6
- 主要终点
- Geriatric Depression Scale
研究概览
简要总结
This study is intended to examine the impact of receiving a genetic risk assessment for Alzheimer's disease (AD) among individuals with Mild Cognitive Impairment (MCI).
详细描述
Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. Apolipoprotein E (APOE) is one gene which can provide information about a person's chances of developing Alzheimer's disease.
Some people with a diagnosis of Mild Cognitive Impairment (MCI) are curious to learn more about the chance of developing Alzheimer's disease. In the REVEAL IV Study, we are examining the psychological and behavioral impact of learning genetic risk information pertaining to the chance for an individual with MCI to progress to dementia of the Alzheimer's type within three years.
Participation in this study requires an initial phone call which will elicit some demographic information about the participant and his or her study partner. A first in-person visit to the research clinic will consist of an education session, the administration of knowledge and attitudinal surveys and some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Participants with MCI will have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the intervention arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age, the diagnosis of MCI and their own APOE gene test result. Those in the comparison arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age and the diagnosis of MCI, without the APOE gene test result. Participants randomized to the comparison arm will have the opportunity to learn their own APOE gene test result at the end of the study. Participants and their study partners will be followed for 6 months following disclosure of results with 1 additional clinic visit and 1 additional phone interviews.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals (55-90 years old) with Mild Cognitive Impairment (amnestic-MCI as defined by the Petersen criteria)
- •Individuals who have a close friend, relative or spouse (18+) willing to be a study partner. Study partners attend each study visit with the participant and also complete surveys and interviews.
排除标准
- •Individuals with current, untreated anxiety or depression
- •Individuals who do not meet the criteria for amnestic-MCI
- •Individuals who have the diagnosis of dementia or Alzheimer's disease
- •Individuals not fluent in English
- •Individuals who do not have a study partner
研究组 & 干预措施
APOE Genotype Non-Disclosure
Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.
干预措施: Alzheimer's disease risk disclosure (Behavioral)
APOE Genotype Disclosure
Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.
干预措施: APOE genotype and Alzheimer's disease risk disclosure (Behavioral)
结局指标
主要结局
Geriatric Depression Scale
时间窗: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression.
Mini State Trait Anxiety Inventory
时间窗: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
Validated introspective psychological inventory consisting of 6 self-report items pertaining to anxiety affect. Responses are transformed into scores that range from 20 to 80, with higher scores indicating greater anxiety.
次要结局
- Impact of Event Scale (IES)(1-3 Days, 6 Weeks and 6 Months Post-disclosure)
- Psychological Impact of Test Disclosure (IGT-AD)(6 Weeks and 6 Months Post-disclosure)
- Health Behavior and Insurance Changes(Baseline, 6 weeks post-disclosure, and 6 months post-disclosure)
- Recall and Comprehension of Risk Information(6 Weeks and 6 Months Post-disclosure)
- Participant Satisfaction(6 Weeks and 6 Months Post-disclosure)
- User Ratings of Risk Assessment Experience(6 Weeks and 6 Months Post-disclosure)
- Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.(6 weeks and 6 months post-disclosure)
- Insurance and Advance Planning Changes(6 months post-disclosure)
研究者
Robert C. Green, MD, MPH
Principal Investigator, The REVEAL Study
Brigham and Women's Hospital