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
  Purpose

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).


Condition Intervention
Mild Cognitive Impairment
Behavioral: APOE genotype disclosure and Alzheimer's disease risk disclosure
Behavioral: Alzheimer's disease risk disclosure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 360
Study Start Date: January 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: APOE Genotype Non-Disclosure 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.
Experimental: APOE Genotype Disclosure 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434667

Locations
United States, District of Columbia
Howard University
Washington, District of Columbia, United States, 20060
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Brigham and Women's Hospital
University of Michigan
University of Pennsylvania
Howard University
Investigators
Principal Investigator: Robert C Green, MD, MPH Brigham and Women's Hospital/Harvard Medical School
  More Information

Additional Information:
Publications:

Responsible Party: Robert C. Green, MD, MPH, Principal Investigator, The REVEAL Study, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01434667     History of Changes
Other Study ID Numbers: R01HG002213, R01HG002213
Study First Received: September 7, 2011
Last Updated: July 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
Mild Cognitive Impairment (MCI)
Alzheimer's disease (AD)
APOE
genetics
risk assessment
education
genetic counseling
Mild Cognitive Impairment, So Stated

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 14, 2014