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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00571025
First received: December 7, 2007
Last updated: July 22, 2009
Last verified: July 2009
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Behavioral: APOE Disclosure

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Genetic Risk Assessment and Counseling for Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Center for Epidemiological Studies-Depression Scale (CES-D) [ Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: Yes ]
  • Beck Anxiety Inventory (BAI) [ Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Impact of Events Scale (IES) [ Time Frame: 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: No ]
  • Future Attitudes Scale (FAS) [ Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: No ]
  • Positive and Negative Affect Schedule (PANAS) [ Time Frame: baseline, 6 weeks, 6 months, 12 months post-disclosure ] [ Designated as safety issue: No ]

Enrollment: 301
Study Start Date: August 2000
Study Completion Date: April 2004
Arms Assigned Interventions
Experimental: 1
AD risk assessment based on family history and APOE genotype
Behavioral: APOE Disclosure
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.
Active Comparator: 2
AD risk assessment based on family history alone
Behavioral: APOE Disclosure
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease and told their own APOE genotype.

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571025

Locations
United States, Massachusetts
Boston University School of Medicine
Boston, Massachusetts, United States, 02118
United States, New York
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, Ohio
Case Western Reserve University
Cleveland, Ohio, United States, 44120
Sponsors and Collaborators
Investigators
Principal Investigator: Robert C. Green, MD, MPH Boston University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Robert C. Green, MD, MPH, Boston University School of Medicine
ClinicalTrials.gov Identifier: NCT00571025     History of Changes
Other Study ID Numbers: IA0126, 5R01HG002213
Study First Received: December 7, 2007
Last Updated: July 22, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
Mild Cognitive Impairment
disease/disorder proneness/risk
family genetics
genetic counseling
genetic marker
genetic polymorphism
genetic susceptibility

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014