Clinical trial NCT01434667: Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Official title: Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment (MCI)
Alzheimer's disease (AD)
APOE
genetics
risk assessment
education
genetic counseling
Mild Cognitive Impairment, So Stated
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Human Genome Research Institute (NHGRI)
name: University of Michigan
name: University of Pennsylvania
name: Howard University
First posted: 2011-09-15
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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).

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 criteria: 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

Primary outcomes:
measure: Geriatric Depression Scale
timeFrame: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
measure: Mini State Trait Anxiety Inventory
timeFrame: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
Secondary outcomes:
measure: Impact of Event Scale (IES)
timeFrame: 1-3 Days, 6 Weeks and 6 Months Post-disclosure
measure: Psychological Impact of Test Disclosure (IGT-AD)
timeFrame: 6 Weeks and 6 Months Post-disclosure
measure: Recall and Comprehension of Risk Information
timeFrame: 6 Weeks and 6 Months Post-disclosure
measure: Participant Satisfaction
timeFrame: 6 Weeks and 6 Months Post-disclosure
measure: User Ratings of Risk Assessment Experience
timeFrame: 6 Weeks and 6 Months Post-disclosure
measure: Health Behavior and Insurance Changes
timeFrame: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
measure: Insurance and Advance Planning Changes
timeFrame: 6 months post-disclosure
measure: Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.
timeFrame: 6 weeks and 6 months post-disclosure
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Brigham and Women's Hospital/Harvard Medical School
name: Robert C Green, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roberts JS, Karlawish JH, Uhlmann WR, Petersen RC, Green RC. Mild cognitive impairment in clinical care: a survey of American Academy of Neurology members. Neurology. 2010 Aug 3;75(5):425-31. doi: 10.1212/WNL.0b013e3181eb5872.
citation: Roberts JS, Christensen KD, Green RC. Using Alzheimer's disease as a model for genetic risk disclosure: implications for personal genomics. Clin Genet. 2011 Nov;80(5):407-14. doi: 10.1111/j.1399-0004.2011.01739.x. Epub 2011 Jul 18.
citation: Guan Y, Roter DL, Wolff JL, Gitlin LN, Christensen KD, Roberts JS, Green RC, Erby LH. The impact of genetic counselors' use of facilitative strategies on cognitive and emotional processing of genetic risk disclosure for Alzheimer's disease. Patient Educ Couns. 2018 May;101(5):817-823. doi: 10.1016/j.pec.2017.11.019. Epub 2017 Nov 27.
citation: Guan Y, Roter DL, Erby LH, Wolff JL, Gitlin LN, Roberts JS, Green RC, Christensen KD. Disclosing genetic risk of Alzheimer's disease to cognitively impaired patients and visit companions: Findings from the REVEAL Study. Patient Educ Couns. 2017 May;100(5):927-935. doi: 10.1016/j.pec.2016.12.005. Epub 2016 Dec 14.