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

Mass General Brigham

Status: Completed

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Alzheimer's disease risk disclosure; Behavioral: APOE genotype and Alzheimer's disease risk disclosure

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01434667

R01HG002213 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 146 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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146 participants in 2 patient groups

APOE Genotype Non-Disclosure

Active Comparator group

Description:

Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.

Treatment:

Behavioral: Alzheimer's disease risk disclosure

APOE Genotype Disclosure

Experimental group

Description:

Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.

Treatment:

Behavioral: APOE genotype and Alzheimer's disease risk disclosure