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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Michigan
University of Pennsylvania
Howard University
Information provided by (Responsible Party):
Robert C. Green, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01434667
First received: September 7, 2011
Last updated: July 30, 2013
Last verified: July 2013

September 7, 2011
July 30, 2013
January 2010
June 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01434667 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
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).

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Mild Cognitive Impairment
  • Behavioral: APOE genotype disclosure and Alzheimer's disease risk disclosure
    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.
  • Behavioral: Alzheimer's disease risk disclosure
    Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
  • Active Comparator: APOE Genotype Non-Disclosure
    Intervention: Behavioral: Alzheimer's disease risk disclosure
  • Experimental: APOE Genotype Disclosure
    Intervention: Behavioral: APOE genotype disclosure and Alzheimer's disease risk disclosure

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
360
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Individuals with Mild Cognitive Impairment (amnestic-MCI as defined by the Petersen criteria)
  • Individuals who have a close friend, relative or spouse 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
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01434667
R01HG002213, R01HG002213
No
Robert C. Green, MD, MPH, Brigham and Women's Hospital
Brigham and Women's Hospital
  • National Human Genome Research Institute (NHGRI)
  • University of Michigan
  • University of Pennsylvania
  • Howard University
Principal Investigator: Robert C Green, MD, MPH Brigham and Women's Hospital/Harvard Medical School
Brigham and Women's Hospital
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP