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Completed

NCT Number: NCT01434667

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

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).

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Howard University, Washington D.C., District of Columbia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

APOE genotype and Alzheimer's disease risk disclosure

Behavioral

Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.

Alzheimer's Disease Risk Disclosure

Behavioral

Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.

Primary outcomes

  1. Geriatric Depression Scale

    Time frame: 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.

  2. Mini State Trait Anxiety Inventory

    Time frame: 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.

Secondary outcomes

  1. Impact of Event Scale (IES)

    Time frame: 1-3 Days, 6 Weeks and 6 Months Post-disclosure

    The Impact of Event assesses intrusive thoughts and avoidance related to a specific stressful life event. It is a 15-item self-report measure with scores that range from 0 to 75, with greater scores indicating greater distress about the event.

  2. Psychological Impact of Test Disclosure (IGT-AD)

    Time frame: 6 Weeks and 6 Months Post-disclosure

    A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress. Higher scores indicate greater distress about the risk assessment.

  3. Recall and Comprehension of Risk Information

    Time frame: 6 Weeks and 6 Months Post-disclosure

    Several measures to assess participant recall and comprehension of personalized risk information for AD. The sum number correct of the two items that were presented to both randomization arms ("What form of APOE increases risk for Alzheimer's disease?", and "What percentage were you given as your 3-year risk of developing Alzheimer's disease?") are summarized here.

  4. Participant Satisfaction

    Time frame: 6 Weeks and 6 Months Post-disclosure

    How well participants' expectations about information, explanations, reassurance, advice, and help in decision making were met. Participants rated satisfaction for each dimension on a 1-7 scale, with higher scores indicating that expectations were met better.

  5. User Ratings of Risk Assessment Experience

    Time frame: 6 Weeks and 6 Months Post-disclosure

    Subjective ratings of the impact of risk assessment. Participants provided ratings on a 1-5 scale, with 1 being "very negative" and 5 being "very positive"

  6. Health Behavior and Insurance Changes

    Time frame: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure

    AD prevention behaviors enacted within the prior two weeks.

  7. Insurance and Advance Planning Changes

    Time frame: 6 months post-disclosure

    A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.

  8. Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.

    Time frame: 6 weeks and 6 months post-disclosure

    Yes/no response to the question, "Since receiving your Alzheimer's disease risk estimate, have you joined any other Alzheimer's disease-related research studies?"

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Howard University
  • National Human Genome Research Institute (NHGRI)
  • University of Michigan
  • University of Pennsylvania

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Sep 15, 2011
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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