NCT00089882

Brief Summary

The REVEAL II study provides healthy adult children and siblings of Alzheimer's disease patients with genetic testing and information about their own chances of developing the disease. The study will compare a condensed education and counseling program to the current more extensive program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2003

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 17, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

July 23, 2009

Status Verified

July 1, 2009

Enrollment Period

3.3 years

First QC Date

August 17, 2004

Last Update Submit

July 22, 2009

Conditions

Alzheimer Disease

Keywords

Alzheimer diseaseApolipoproteins E (APOE)Genetic susceptibility testing

Interventions

APOE Genetic susceptibility testingPROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult children or siblings of people with Alzheimer's disease.

You may not qualify if:

  • Adult children or siblings of people with Alzheimer's disease who are unable to visit a study site.
  • Persons with currently untreated depression, anxiety or severe mood disturbances.
  • Persons with cognitive deficits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Howard University College of Medicine, National Human Genome Center

Washington D.C., District of Columbia, 20059, United States

Location

Boston University School of Medicine, Alzheimer's Disease Center

Boston, Massachusetts, 02118, United States

Location

Weill Medical College of Cornell University, Memory Disorders Program

New York, New York, 10021, United States

Location

Case Western Reserve University, Memory and Aging Center

Cleveland, Ohio, 44120, United States

Location

Related Publications (6)

  • Hipps YG, Roberts JS, Farrer LA, Green RC. Differences between African Americans and Whites in their attitudes toward genetic testing for Alzheimer's disease. Genet Test. 2003 Spring;7(1):39-44. doi: 10.1089/109065703321560921.

    PMID: 12820701BACKGROUND

  • Roberts JS, LaRusse SA, Katzen H, Whitehouse PJ, Barber M, Post SG, Relkin N, Quaid K, Pietrzak RH, Cupples LA, Farrer LA, Brown T, Green RC. Reasons for seeking genetic susceptibility testing among first-degree relatives of people with Alzheimer disease. Alzheimer Dis Assoc Disord. 2003 Apr-Jun;17(2):86-93. doi: 10.1097/00002093-200304000-00006.

    PMID: 12794385BACKGROUND

  • Roberts JS, Barber M, Brown TM, Cupples LA, Farrer LA, LaRusse SA, Post SG, Quaid KA, Ravdin LD, Relkin NR, Sadovnick AD, Whitehouse PJ, Woodard JL, Green RC. Who seeks genetic susceptibility testing for Alzheimer's disease? Findings from a multisite, randomized clinical trial. Genet Med. 2004 Jul-Aug;6(4):197-203. doi: 10.1097/01.gim.0000132688.55591.77.

    PMID: 15266207BACKGROUND

  • LaRusse S, Roberts JS, Marteau TM, Katzen H, Linnenbringer EL, Barber M, Whitehouse P, Quaid K, Brown T, Green RC, Relkin NR. Genetic susceptibility testing versus family history-based risk assessment: Impact on perceived risk of Alzheimer disease. Genet Med. 2005 Jan;7(1):48-53. doi: 10.1097/01.gim.0000151157.13716.6c.

    PMID: 15654228RESULT

  • Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Green RC; REVEAL (Risk Evaluation and Education for Alzheimer's Disease) Study Group. Genetic risk assessment for adult children of people with Alzheimer's disease: the Risk Evaluation and Education for Alzheimer's Disease (REVEAL) study. J Geriatr Psychiatry Neurol. 2005 Dec;18(4):250-5. doi: 10.1177/0891988705281883.

    PMID: 16306249RESULT

  • Christensen KD, Roberts JS, Zikmund-Fisher BJ, Kardia SL, McBride CM, Linnenbringer E, Green RC; REVEAL Study Group. Associations between self-referral and health behavior responses to genetic risk information. Genome Med. 2015 Jan 31;7(1):10. doi: 10.1186/s13073-014-0124-0. eCollection 2015.

    PMID: 25642295DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Robert C. Green, MD, MPH

    Boston University School of Medicine, Genetics Program and Alzheimer's Disease Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

August 17, 2004

First Posted

August 18, 2004

Study Start

May 1, 2003

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

July 23, 2009

Record last verified: 2009-07

Locations

US(4)