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Original Investigation
August 10, 2020

Short-term Psychological Outcomes of Disclosing Amyloid Imaging Results to Research Participants Who Do Not Have Cognitive Impairment

Author Affiliations
  • 1Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, Irvine
  • 2Institute for Clinical and Translational Science, University of California, Irvine, Irvine
  • 3Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine
  • 4Department of Neurobiology and Behavior, University of California, Irvine, Irvine
  • 5Alzheimer's Therapeutic Research Institute, University of Southern California, San Diego, San Diego
  • 6VA Greater Los Angeles Healthcare System, David Geffen School of Medicine at UCLA, Los Angeles, California
  • 7Department of Psychiatry and Human Behavior, University of California, Irvine, Irvine
  • 8University of Kansas Alzheimer's Disease Center, Kansas City
  • 9Division of Molecular Imaging and Nuclear Medicine, Department of Radiology, Massachusetts General Hospital, Boston
  • 10Harvard Medical School, Center for Alzheimer Research and Treatment, Brigham and Women's Hospital, Boston, Massachusetts
  • 11Department of Medical Ethics and Health Policy, University of Pennsylvania, Philadelphia
  • 12Department of Medicine, University of Pennsylvania, Philadelphia
  • 13Department of Neurology, University of Pennsylvania, Philadelphia
JAMA Neurol. 2020;77(12):1504-1513. doi:10.1001/jamaneurol.2020.2734
Key Points

Question  Can Alzheimer disease biomarker results be safely shared with older research participants who do not have cognitive impairments?

Findings  In this observational study, disclosure of amyloid imaging results using a structured process in a clinical trial did not result in clinically meaningful short-term adverse psychological reactions but did change participants’ perceived risk of developing Alzheimer disease.

Meaning  In this study, in the short term, amyloid imaging results were safely disclosed to older adults who did not have cognitive impairment.

Abstract

Importance  The goal of preclinical Alzheimer disease (AD) clinical trials is to move diagnosis and treatment to presymptomatic stages, which will require biomarker testing and disclosure.

Objective  To assess the short-term psychological outcomes of disclosing amyloid positron emission tomography results to older adults who did not have cognitive impairment.

Design, Setting, and Participants  This observational study included participants who were screening for a multisite randomized clinical trial that began on February 28, 2014, and is anticipated to be completed in 2022. Participants aged 65 to 85 years who had no known cognitive impairments underwent an amyloid positron emission tomography scan and learned their result from an investigator who used a protocol-specified process that included prescan education and psychological assessments. This report compares participants with elevated amyloid levels with at least 1 available outcome measure with participants who did not have elevated amyloid levels who enrolled in an observational cohort study and received further evaluations. Data were collected from April 2014 to December 2017 and analyzed from March 2019 to October 2019.

Exposures  A personal biomarker result described as either an elevated or not elevated amyloid level.

Main Outcomes and Measures  To assess the immediate and short-term psychological outcome of disclosure, the following validated measures were used: the Geriatric Depression Scale, the state items from the State-Trait Anxiety Inventory, and the Columbia Suicide Severity Rating Scale, as well as the Concerns About AD Scale and the Future Time Perspective Scale to assess changes in participants’ perceived risk for AD and perceived remaining life span, respectively.

Results  A total of 1167 participants with elevated amyloid levels and 538 participants with not elevated amyloid levels were included. Participants had a mean (SD) age of 71.5 (4.7) years, 1025 (60.1%) were women, and most were white (1611 [94.5%]) and non-Latino (1638 [96.1%]). Compared with participants who learned that they had a not elevated amyloid result, individuals who learned of an elevated amyloid result were no more likely to experience short-term increases in depression (mean [SD] change in the Geriatric Depression Scale score, 0.02 [1.3] vs 0.04 [1.3]; P = .90), anxiety (mean [SD] change in State-Trait Anxiety Inventory score, –0.02 [3.2] vs –0.15 [3.0]; P = .65), or suicidality (mean [SD] change in the Columbia Suicide Severity Rating Scale score, 0.0 [0.4] vs –0.01 [0.5]; P = .67). Participants with elevated amyloid levels had increased Concern About AD scores (raw change in scores: elevated amyloid group, 0.8 [3.9]; not elevated amyloid group, –0.4 [3.8]; P < .001). Participants with not elevated amyloid levels experienced a slight increase in Future Time Perspective score(mean [SD] score, 1.15 [7.4] points; P < .001); there was no change in time perspective among those receiving an elevated amyloid result (mean [SD] score, 0.33 [7.8] points).

Conclusions and Relevance  In this observational preclinical AD study, participants who learned they had elevated amyloid levels did not experience short-term negative psychological sequelae compared with persons who learned they did not have elevated amyloid levels.

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