NCT00571025

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
301

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

3 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

August 1, 2000

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 11, 2007

Completed
Last Updated

July 23, 2009

Status Verified

July 1, 2009

First QC Date

December 7, 2007

Last Update Submit

July 22, 2009

Conditions

Alzheimer's Disease

Keywords

Mild Cognitive Impairmentdisease/disorder proneness/riskfamily geneticsgenetic counselinggenetic markergenetic polymorphismgenetic susceptibility

Outcome Measures

Primary Outcomes (2)

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

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

  • Beck Anxiety Inventory (BAI)

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

Secondary Outcomes (3)

  • Impact of Events Scale (IES)

    6 weeks, 6 months, 12 months post-disclosure

  • Future Attitudes Scale (FAS)

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

  • Positive and Negative Affect Schedule (PANAS)

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

Study Arms (2)

1

EXPERIMENTAL

AD risk assessment based on family history and APOE genotype

Behavioral: APOE Disclosure

2

ACTIVE COMPARATOR

AD risk assessment based on family history alone

Behavioral: APOE Disclosure

Interventions

APOE DisclosureBEHAVIORAL

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

12

Eligibility Criteria

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

You may qualify if:

  • Adult children of a person with clinically diagnosed and/or autopsy-confirmed Alzheimer's disease
  • years or older

You may not qualify if:

  • Current dementia
  • Current untreated depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Case Western Reserve University

Cleveland, Ohio, 44120, United States

Location

Related Publications (4)

  • Farrer LA, Cupples LA, Haines JL, Hyman B, Kukull WA, Mayeux R, Myers RH, Pericak-Vance MA, Risch N, van Duijn CM. Effects of age, sex, and ethnicity on the association between apolipoprotein E genotype and Alzheimer disease. A meta-analysis. APOE and Alzheimer Disease Meta Analysis Consortium. JAMA. 1997 Oct 22-29;278(16):1349-56.

    PMID: 9343467BACKGROUND

  • Green RC, Clarke VC, Thompson NJ, Woodard JL, Letz R. Early detection of Alzheimer disease: methods, markers, and misgivings. Alzheimer Dis Assoc Disord. 1997;11 Suppl 5:S1-5; discussion S37-9. doi: 10.1016/s0197-4580(96)80334-4.

    PMID: 9348421BACKGROUND

  • Green RC, Cupples LA, Go R, Benke KS, Edeki T, Griffith PA, Williams M, Hipps Y, Graff-Radford N, Bachman D, Farrer LA; MIRAGE Study Group. Risk of dementia among white and African American relatives of patients with Alzheimer disease. JAMA. 2002 Jan 16;287(3):329-36. doi: 10.1001/jama.287.3.329.

    PMID: 11790212BACKGROUND

  • Green RC, Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Brown T, Eckert SL, Butson M, Sadovnick AD, Quaid KA, Chen C, Cook-Deegan R, Farrer LA; REVEAL Study Group. Disclosure of APOE genotype for risk of Alzheimer's disease. N Engl J Med. 2009 Jul 16;361(3):245-54. doi: 10.1056/NEJMoa0809578.

    PMID: 19605829DERIVED

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionDisease SusceptibilityGenetic Predisposition to Disease

Condition Hierarchy (Ancestors)

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

Study Officials

  • Robert C. Green, MD, MPH

    Boston University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 11, 2007

Study Start

August 1, 2000

Study Completion

April 1, 2004

Last Updated

July 23, 2009

Record last verified: 2009-07

Locations

US(3)