NCT01434667

Brief Summary

This study is intended to examine the impact of receiving a genetic risk assessment for Alzheimer's disease (AD) among individuals with Mild Cognitive Impairment (MCI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2010

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

January 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 7, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

October 23, 2018

Completed
Last Updated

October 23, 2018

Status Verified

September 1, 2018

Enrollment Period

4.5 years

First QC Date

September 7, 2011

Results QC Date

September 24, 2018

Last Update Submit

September 24, 2018

Conditions

Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment (MCI)Alzheimer's disease (AD)APOEgeneticsrisk assessmenteducationgenetic counselingMild Cognitive Impairment, So Stated

Outcome Measures

Primary Outcomes (2)

  • Geriatric Depression Scale

    A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression.

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

  • Mini State Trait Anxiety Inventory

    Validated introspective psychological inventory consisting of 6 self-report items pertaining to anxiety affect. Responses are transformed into scores that range from 20 to 80, with higher scores indicating greater anxiety.

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

Secondary Outcomes (8)

  • Impact of Event Scale (IES)

    1-3 Days, 6 Weeks and 6 Months Post-disclosure

  • Psychological Impact of Test Disclosure (IGT-AD)

    6 Weeks and 6 Months Post-disclosure

  • Recall and Comprehension of Risk Information

    6 Weeks and 6 Months Post-disclosure

  • Participant Satisfaction

    6 Weeks and 6 Months Post-disclosure

  • User Ratings of Risk Assessment Experience

    6 Weeks and 6 Months Post-disclosure

  • +3 more secondary outcomes

Study Arms (2)

APOE Genotype Non-Disclosure

ACTIVE COMPARATOR

Subjects will receive Alzheimer's disease risk disclosure. This assessment is based on age and MCI status alone.

Behavioral: Alzheimer's disease risk disclosure

APOE Genotype Disclosure

EXPERIMENTAL

Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure. The assessment is based on age, MCI status, and genotype.

Behavioral: APOE genotype and Alzheimer's disease risk disclosure

Interventions

APOE genotype and Alzheimer's disease risk disclosureBEHAVIORAL

Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.

APOE Genotype Disclosure
Alzheimer's disease risk disclosureBEHAVIORAL

Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.

APOE Genotype Non-Disclosure

Eligibility Criteria

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

You may qualify if:

  • Individuals (55-90 years old) with Mild Cognitive Impairment (amnestic-MCI as defined by the Petersen criteria)
  • Individuals who have a close friend, relative or spouse (18+) willing to be a study partner. Study partners attend each study visit with the participant and also complete surveys and interviews.

You may not qualify if:

  • Individuals with current, untreated anxiety or depression
  • Individuals who do not meet the criteria for amnestic-MCI
  • Individuals who have the diagnosis of dementia or Alzheimer's disease
  • Individuals not fluent in English
  • Individuals who do not have a study partner

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Howard University

Washington D.C., District of Columbia, 20060, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (4)

  • Roberts JS, Karlawish JH, Uhlmann WR, Petersen RC, Green RC. Mild cognitive impairment in clinical care: a survey of American Academy of Neurology members. Neurology. 2010 Aug 3;75(5):425-31. doi: 10.1212/WNL.0b013e3181eb5872.

    PMID: 20679636BACKGROUND

  • 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

  • Guan Y, Roter DL, Wolff JL, Gitlin LN, Christensen KD, Roberts JS, Green RC, Erby LH. The impact of genetic counselors' use of facilitative strategies on cognitive and emotional processing of genetic risk disclosure for Alzheimer's disease. Patient Educ Couns. 2018 May;101(5):817-823. doi: 10.1016/j.pec.2017.11.019. Epub 2017 Nov 27.

    PMID: 29203084RESULT

  • Guan Y, Roter DL, Erby LH, Wolff JL, Gitlin LN, Roberts JS, Green RC, Christensen KD. Disclosing genetic risk of Alzheimer's disease to cognitively impaired patients and visit companions: Findings from the REVEAL Study. Patient Educ Couns. 2017 May;100(5):927-935. doi: 10.1016/j.pec.2016.12.005. Epub 2016 Dec 14.

    PMID: 28012682RESULT

Related Links

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Kurt Christensen, PhD
Organization
Brigham and Women's Hospital
kchristensen@bwh.harvard.edu
(617) 264-5883

Study Officials

  • Robert C Green, MD, MPH

    Brigham and Women's Hospital/Harvard Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, The REVEAL Study

Study Record Dates

First Submitted

September 7, 2011

First Posted

September 15, 2011

Study Start

January 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

October 23, 2018

Results First Posted

October 23, 2018

Record last verified: 2018-09

Locations

US(3)