NCT00462917

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
290

participants targeted

Target at P75+ for not_applicable alzheimer-disease

Timeline
Completed

Started Mar 2007

Typical duration for not_applicable alzheimer-disease

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

March 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 19, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

September 11, 2014

Completed
Last Updated

October 23, 2018

Status Verified

September 1, 2018

Enrollment Period

2.6 years

First QC Date

April 17, 2007

Results QC Date

August 21, 2014

Last Update Submit

September 25, 2018

Conditions

Alzheimer Disease

Keywords

disease /disorder proneness /riskfamily geneticsgenetic counselinggenetic markergenetic polymorphismgenetic screeninggenetic susceptibility

Outcome Measures

Primary Outcomes (2)

  • Center for Epidemiological Studies-Depression Scale (CES-D)

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

    6 weeks, 6 months, and 12 months post-disclosure

  • Beck Anxiety Inventory (BAI)

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

    6 weeks, 6 months, 12 months post-disclosure

Secondary Outcomes (1)

  • Impact of Events Scale (IES)

    6 weeks, 6 months, 12 months post-disclosure

Study Arms (4)

Pleiotropic info, in-person disclosure

EXPERIMENTAL

Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment

Behavioral: Pleiotropic info, in-person disclosure

AD-only info, phone disclosure

EXPERIMENTAL

Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment

Behavioral: AD-only info, phone disclosure

Pleiotropic info, phone disclosure

EXPERIMENTAL

Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment

Behavioral: Pleiotropic info, phone disclosure

AD-only info, in-person disclosure

ACTIVE COMPARATOR

Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment

Behavioral: AD-only info, in-person disclosure

Interventions

Pleiotropic info, in-person disclosureBEHAVIORAL

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.

Pleiotropic info, in-person disclosure
AD-only info, in-person disclosureBEHAVIORAL

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.

AD-only info, in-person disclosure
Pleiotropic info, phone disclosureBEHAVIORAL

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.

Pleiotropic info, phone disclosure
AD-only info, phone disclosureBEHAVIORAL

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.

AD-only info, phone disclosure

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years to 85 years old

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Howard University

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

Location

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44120, United States

Location

Related Publications (10)

  • 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: 15654228BACKGROUND

  • 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: 16306249BACKGROUND

  • Roberts JS, Christensen KD, Green RC. Using Alzheimer's disease as a model for genetic risk disclosure: implications for personal genomics. Clin Genet. 2011 Nov;80(5):407-14. doi: 10.1111/j.1399-0004.2011.01739.x. Epub 2011 Jul 18.

    PMID: 21696382BACKGROUND

  • Christensen KD, Uhlmann WR, Roberts JS, Linnenbringer E, Whitehouse PJ, Royal CDM, Obisesan TO, Cupples LA, Butson MB, Fasaye GA, Hiraki S, Chen CA, Siebert U, Cook-Deegan R, Green RC. A randomized controlled trial of disclosing genetic risk information for Alzheimer disease via telephone. Genet Med. 2018 Jan;20(1):132-141. doi: 10.1038/gim.2017.103. Epub 2017 Jul 20.

    PMID: 28726810RESULT

  • Christensen KD, Roberts JS, Whitehouse PJ, Royal CD, Obisesan TO, Cupples LA, Vernarelli JA, Bhatt DL, Linnenbringer E, Butson MB, Fasaye GA, Uhlmann WR, Hiraki S, Wang N, Cook-Deegan R, Green RC; REVEAL Study Group*. Disclosing Pleiotropic Effects During Genetic Risk Assessment for Alzheimer Disease: A Randomized Trial. Ann Intern Med. 2016 Feb 2;164(3):155-63. doi: 10.7326/M15-0187. Epub 2016 Jan 26.

    PMID: 26810768RESULT

  • 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: 25642295RESULT

  • Besser AG, Sanderson SC, Roberts JS, Chen CA, Christensen KD, Lautenbach DM, Cupples LA, Green RC. Factors affecting recall of different types of personal genetic information about Alzheimer's disease risk: the REVEAL study. Public Health Genomics. 2015;18(2):78-86. doi: 10.1159/000368888. Epub 2015 Jan 24.

    PMID: 25634646RESULT

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseDisease SusceptibilityGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Robert C. Green, MD, MPH
Organization
Brigham and Women's Hospital and Harvard Medical School
rcgreen@genetics.med.harvard.edu
617-264-5838

Study Officials

  • Robert Green, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 19, 2007

Study Start

March 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

October 23, 2018

Results First Posted

September 11, 2014

Record last verified: 2018-09

Locations

US(4)