Risk Evaluation and Education for Alzheimer's Disease

NCT ID: NCT00571025

Last Updated: 2009-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-08-31

Study Completion Date

2004-04-30

Brief Summary

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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

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

AD risk assessment based on family history and APOE genotype

Group Type EXPERIMENTAL

APOE Disclosure

Intervention Type BEHAVIORAL

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.

2

AD risk assessment based on family history alone

Group Type ACTIVE_COMPARATOR

APOE Disclosure

Intervention Type BEHAVIORAL

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.

Interventions

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APOE Disclosure

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

National Human Genome Research Institute (NHGRI)

NIH

Sponsor Role lead

Responsible Party

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Boston University School of Medicine

Principal Investigators

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Robert C. Green, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

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Boston University School of Medicine

Boston, Massachusetts, United States

Site Status

Weill Medical College of Cornell University

New York, New York, United States

Site Status

Case Western Reserve University

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 9343467 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9348421 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11790212 (View on PubMed)

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.

Reference Type DERIVED
PMID: 19605829 (View on PubMed)

Other Identifiers

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5R01HG002213

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IA0126

Identifier Type: -

Identifier Source: org_study_id

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