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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434667
• Other study ID #: R01HG002213
• Secondary ID: R01HG002213
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: July 2014

Study information

• Verified date: September 2018
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Howard University	Washington	District of Columbia

Sponsors (5)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Howard University, National Human Genome Research Institute (NHGRI), University of Michigan, University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (4)

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) — View 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 C — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geriatric Depression Scale	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
Primary	Mini State Trait Anxiety Inventory	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	Impact of Event Scale (IES)	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
Secondary	Psychological Impact of Test Disclosure (IGT-AD)	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
Secondary	Recall and Comprehension of Risk Information	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
Secondary	Participant Satisfaction	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
Secondary	User Ratings of Risk Assessment Experience	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
Secondary	Health Behavior and Insurance Changes	AD prevention behaviors enacted within the prior two weeks.	Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
Secondary	Insurance and Advance Planning Changes	A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.	6 months post-disclosure
Secondary	Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.	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

External Links

•   Alzheimer's Association - Educational Materials on Mild Cognitive Impairment
•   Alzheimer's Association - Educational Materials on Risk Factors
•   REVEAL Study overview