Overview

This trial is active, not recruiting.

Condition mild cognitive impairment
Treatments apoe genotype disclosure and alzheimer's disease risk disclosure, alzheimer's disease risk disclosure
Sponsor Brigham and Women's Hospital
Collaborator National Human Genome Research Institute (NHGRI)
Start date January 2010
End date June 2014
Trial size 360 participants
Trial identifier NCT01434667, R01HG002213

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
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 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.

Primary Outcomes

Measure
Change in Geriatric Depression Rating Scale
time frame: Change from Baseline at 6 Weeks, 6 Months and 12 Months Post-disclosure
Change in Mini-State Trait Anxiety Inventory
time frame: Change from Baseline at 6 Weeks, 6 Months and 12 Months Post-disclosure

Secondary Outcomes

Measure
Test-Specific Distress
time frame: 1-3 Days, 6 Weeks, 6 Months and 12 Months Post-disclosure
Psychological Impact of Test Disclosure (IGT-AD)
time frame: 6 Weeks, 6 Months and 12 Months Post-disclosure
Recall and Comprehension of Risk Information
time frame: 6 Weeks, 6 Months and 12 Months Post-disclosure
Participant Satisfaction
time frame: Baseline, 6 Weeks, 6 Months and 12 Months Post-disclosure
User Ratings of Risk Assessment Experience
time frame: Baseline
Health Behavior and Insurance Changes
time frame: 6 Weeks, 6 Months and 12 Months Post-disclosure

Eligibility Criteria

Male or female participants from 55 years up to 90 years old.

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

Additional Information

Official title Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Principal investigator Robert C Green, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Brigham and Women's Hospital.