Clinical trial NCT00571025: Risk Evaluation and Education for Alzheimer's Disease
Official title: Genetic Risk Assessment and Counseling for Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer's Disease
Keywords: Mild Cognitive Impairment
disease/disorder proneness/risk
family genetics
genetic counseling
genetic marker
genetic polymorphism
genetic susceptibility
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
Collaborators: name: National Institute on Aging (NIA)
First posted: 2007-12-11
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to determine the characteristics of those who obtain genetic susceptibility testing for Alzheimer's disease with APOE disclosure and to study the psychological and behavioral consequences of providing this information.

Detailed description: Advances in genetic research have led to an increased number of testing procedures to determine future risk of disease among at-risk individuals. An increasing number of genes are being identified that confer susceptibility for a given disease rather than inevitably causing it. Given that such genes may provide risk information for common diseases (e.g., stroke, depression), there is a growing need to understand how at-risk populations might respond to the option of genetic susceptibility testing. A prominent case in point is Alzheimer's disease (AD).

Participation in this study requires an initial phone call which will elicit some medical and family history information about the participant. A first in-person visit to the clinic will consist of an education session and the administration of some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Approximately 2 weeks later, participants will return to have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the experimental arm will receive information on their risk based on their family history and APOE genotype, while those in the active comparator arm will receive information on their risk for developing Alzheimer's disease based on their family history alone. Participants will be followed for 1 year following disclosure of results with 2 additional clinic visits.

Eligibility criteria: Inclusion Criteria:

* Adult children of a person with clinically diagnosed and/or autopsy-confirmed Alzheimer's disease
* 18 years or older

Exclusion Criteria:

* Current dementia
* Current untreated depression

Primary outcomes:
measure: Center for Epidemiological Studies-Depression Scale (CES-D)
timeFrame: baseline, 6 weeks, 6 months, 12 months post-disclosure
measure: Beck Anxiety Inventory (BAI)
timeFrame: baseline, 6 weeks, 6 months, 12 months post-disclosure
Secondary outcomes:
measure: Impact of Events Scale (IES)
timeFrame: 6 weeks, 6 months, 12 months post-disclosure
measure: Future Attitudes Scale (FAS)
timeFrame: baseline, 6 weeks, 6 months, 12 months post-disclosure
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: baseline, 6 weeks, 6 months, 12 months post-disclosure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University School of Medicine
state: Massachusetts
city: New York
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Boston University
name: Robert C. Green, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Farrer LA, Cupples LA, Haines JL, Hyman B, Kukull WA, Mayeux R, Myers RH, Pericak-Vance MA, Risch N, van Duijn CM. Effects of age, sex, and ethnicity on the association between apolipoprotein E genotype and Alzheimer disease. A meta-analysis. APOE and Alzheimer Disease Meta Analysis Consortium. JAMA. 1997 Oct 22-29;278(16):1349-56.
citation: Green RC, Clarke VC, Thompson NJ, Woodard JL, Letz R. Early detection of Alzheimer disease: methods, markers, and misgivings. Alzheimer Dis Assoc Disord. 1997;11 Suppl 5:S1-5; discussion S37-9. doi: 10.1016/s0197-4580(96)80334-4.
citation: Green RC, Cupples LA, Go R, Benke KS, Edeki T, Griffith PA, Williams M, Hipps Y, Graff-Radford N, Bachman D, Farrer LA; MIRAGE Study Group. Risk of dementia among white and African American relatives of patients with Alzheimer disease. JAMA. 2002 Jan 16;287(3):329-36. doi: 10.1001/jama.287.3.329.
citation: Green RC, Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Brown T, Eckert SL, Butson M, Sadovnick AD, Quaid KA, Chen C, Cook-Deegan R, Farrer LA; REVEAL Study Group. Disclosure of APOE genotype for risk of Alzheimer's disease. N Engl J Med. 2009 Jul 16;361(3):245-54. doi: 10.1056/NEJMoa0809578.