Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV

• Change in Geriatric Depression Rating Scale [ Time Frame: Change from Baseline at 6 Weeks, 6 Months and 12 Months Post-disclosure ] [ Designated as safety issue: Yes ]
  Validated scale of depression
  
  
• Change in Mini-State Trait Anxiety Inventory [ Time Frame: Change from Baseline at 6 Weeks, 6 Months and 12 Months Post-disclosure ] [ Designated as safety issue: Yes ]
  Validated scale of anxiety
  
  

• Test-Specific Distress [ Time Frame: 1-3 Days, 6 Weeks, 6 Months and 12 Months Post-disclosure ] [ Designated as safety issue: No ]
  Validated scale that assesses two common responses related to a specific stressful life event.
  
  
• Psychological Impact of Test Disclosure (IGT-AD) [ Time Frame: 6 Weeks, 6 Months and 12 Months Post-disclosure ] [ Designated as safety issue: No ]
  A measure designed to assess the impact of genetic test result disclosure across three domains: distress, uncertainty and positive experiences.
  
  
• Recall and Comprehension of Risk Information [ Time Frame: 6 Weeks, 6 Months and 12 Months Post-disclosure ] [ Designated as safety issue: No ]
  Several measures to assess participant recall and comprehension of personalized risk information for AD.
  
  
• Participant Satisfaction [ Time Frame: Baseline, 6 Weeks, 6 Months and 12 Months Post-disclosure ] [ Designated as safety issue: No ]
  How well participants' pre-test expectations are met.
  
  
• User Ratings of Risk Assessment Experience [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  Subjective ratings of the impact and utility of risk assessment.
  
  
• Health Behavior and Insurance Changes [ Time Frame: 6 Weeks, 6 Months and 12 Months Post-disclosure ] [ Designated as safety issue: No ]
  Examine behavior changes, advance planning changes, insurance changes, medication changes, enrollment in clinical research.
  
  

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.