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OpenTrials
Completed

NCT Number: NCT00571025

Risk Evaluation and Education for Alzheimer's Disease

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.

Completed

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston University School of Medicine, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

APOE Disclosure

Behavioral

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

Primary outcomes

  1. Center for Epidemiological Studies-Depression Scale (CES-D)

    Time frame: baseline, 6 weeks, 6 months, 12 months post-disclosure

  2. Beck Anxiety Inventory (BAI)

    Time frame: baseline, 6 weeks, 6 months, 12 months post-disclosure

Secondary outcomes

  1. Impact of Events Scale (IES)

    Time frame: 6 weeks, 6 months, 12 months post-disclosure

  2. Future Attitudes Scale (FAS)

    Time frame: baseline, 6 weeks, 6 months, 12 months post-disclosure

  3. Positive and Negative Affect Schedule (PANAS)

    Time frame: baseline, 6 weeks, 6 months, 12 months post-disclosure

Sponsors and collaborators

Lead sponsor

National Human Genome Research Institute (NHGRI)

Nih

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Genetic Risk Assessment and Counseling for Alzheimer's Disease

Acronym: REVEAL I

Important dates

Study start
2000
Study completion
2004
First posted
Dec 11, 2007
Registry last updated
Jul 23, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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