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Completed

NCT Number: NCT00462917

REVEAL III: Risk Evaluation and Education for Alzheimer's Disease

The purpose of this study is to provide healthy adults with genetic testing and information about their chances of developing Alzheimer's disease.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Disease Attributes Disease Susceptibility Genetic Predisposition to Disease Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tauopathies

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Howard University, Washington D.C., District of Columbia, United States

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About this study

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 that has been identified which can provide information about a person's chances of developing Alzheimer's diseases. Previous research explored the behavioral and psychological impact of receiving genetic risk information for Alzheimer's disease (AD). The REVEAL I Study, funded in 1999, showed that an Alzheimer's disease genetic risk assessment can be given to relatives of people with AD in a safe way. REVEAL II, which was funded in 2003, demonstrated that this same information can be given in a condensed education and counseling protocol without causing severe psychological harm. REVEAL III will further study different ways of providing genetic risk information for Alzheimer's disease.

Participation in this study will entail an initial screening phone call to determine eligibility, followed by a phone interview which will ask about demographic information and thoughts and feelings about AD. Participants will complete a mailed survey. Following completion of the survey, a genetic counselor will meet with the participant at the clinic to review family and medical history, administer additional questionnaires asking about AD and genetic testing, and draw blood for genetic testing. Results will be disclosed either in person or over the phone about 3 to 4 weeks later. The genetic counselor will make a brief follow-up phone call 1 week after that. The participant will visit the clinic twice to provide additional information, at 6 weeks and 6 months after disclosure. Finally, the participant will complete a mailed 12 month survey, and the genetic counselor will make a brief follow-up phone call.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18 years to 85 years old

Exclusion criteria

  • Unable to visit a study site
  • Current untreated depression or anxiety
  • Family history of AD diagnosed under age 60
  • More than one first-degree relative diagnosed with AD (e.g. Mother and brother)

Treatment and study plan

Pleiotropic info, in-person disclosure

Behavioral

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.

Genetic counselors communicate results to participants during an in-person disclosure session.

AD-only info, in-person disclosure

Behavioral

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.

Genetic counselors communicate results to participants during an in-person disclosure session.

Pleiotropic info, phone disclosure

Behavioral

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.

Genetic counselors communicate results to participants during a telephone disclosure session.

AD-only info, phone disclosure

Behavioral

Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.

Genetic counselors communicate results to participants during an in-person disclosure session.

Primary outcomes

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

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

    A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.

  2. Beck Anxiety Inventory (BAI)

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

    A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.

Secondary outcomes

  1. Impact of Events Scale (IES)

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

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Human Genome Research Institute (NHGRI)

Registry information

Official study title

Risk Evaluation and Education for Alzheimer's Disease

Acronym: REVEAL

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Apr 19, 2007
Registry last updated
Oct 23, 2018

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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