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

September 24, 2018 updated by: Robert C. Green, MD, MPH, Brigham and Women's Hospital
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20060
        • Howard University
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: APOE Genotype Non-Disclosure
Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.
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
Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.
Behavioral: APOE genotype 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
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.
Baseline, 6 weeks post-disclosure, and 6 months post-disclosure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1-3 Days, 6 Weeks and 6 Months Post-disclosure
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.
6 Weeks and 6 Months Post-disclosure
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.
6 Weeks and 6 Months Post-disclosure
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.
6 Weeks and 6 Months Post-disclosure
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 Weeks and 6 Months Post-disclosure
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.
Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
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.
6 months post-disclosure
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?"
6 weeks and 6 months post-disclosure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

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

Investigators

  • Principal Investigator: Robert C Green, MD, MPH, Brigham and Women's Hospital/Harvard Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

September 7, 2011

First Submitted That Met QC Criteria

September 14, 2011

First Posted (Estimate)

September 15, 2011

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01HG002213 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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