Sharing concerning test results with Alzheimer’s research participants does not cause distress, studies find
A recent NIA-supported study of preclinical Alzheimer’s disease found that sharing elevated amyloid test results with research participants did not cause them to experience significant short-term psychological distress. The study also indicated that sharing this concerning information did change participants’ perceived risk of developing the disease. Preclinical Alzheimer’s is the earliest stage of the disease, when brain changes are taking place, but symptoms are not yet present.
Published in JAMA Neurology, the NIA-funded study is part of the Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) Study, a large clinical trial testing an investigational anti-amyloid treatment for Alzheimer’s. To participate in A4, people without cognitive impairment had to show evidence of elevated amyloid levels on an amyloid positron emission tomography (PET) scan. Higher levels of the protein beta-amyloid indicate an increased risk for Alzheimer’s disease. Those without elevated amyloid levels were invited to participate in a sister study, the Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) trial.
A total of 1,167 participants with elevated amyloid levels were compared to 538 participants whose amyloid levels were normal. Both groups were similar in age (65 to 85 years old), race, gender, and ethnicity. Participants received predisclosure education and assessments and post-disclosure assessments. When comparing results before and after disclosure, researchers found that participants who had elevated amyloid levels were no more likely than those without elevated levels to experience depression, anxiety, or catastrophic reactions such as suicide in the short term. However, those with elevated amyloid levels had increased levels of concerns about developing Alzheimer’s disease while those without elevated amyloid levels had decreased levels of concerns about developing the disease. Results point to participants’ knowledge of their risk of developing the disease, researchers noted, but that the perceived risk did not appear to be associated with adverse reactions.
Another NIA-funded study published in PLOS One investigated the implications of amyloid disclosure on a smaller sample pulled from the A4 and LEARN studies. In the Study of Knowledge and Reactions to Amyloid Testing (SOKRATES), researchers interviewed 80 participants via telephone after they had received their amyloid PET scan results. Participants who had elevated amyloid levels were more likely to view the results as more serious and sensitive than other medical tests but did not display great distress. Some participants expressed concern that an elevated amyloid level might change the way they are perceived and treated by others. Participants with higher amyloid levels were also more likely to consider making more changes in health behaviors and future plans than those without elevated amyloid. The majority — two-thirds — of participants without elevated amyloid reported a feeling of relief at learning their status, and about half reported reinterpreting perceived memory issues as normal aging.
More research is needed to learn whether negative reactions develop over time and to understand how reactions may differ in diverse populations. Findings of studies into the effects of disclosure and how to disclose have implications for research studies that may by design indicate someone’s status or may offer participants the opportunity to learn about their status. In the future, such findings could also apply to clinical settings. Current practice in clinical settings is to not disclose biomarker results that indicate increased risk for dementia to people with no cognitive impairment. However, if an early-stage treatment becomes available or biomarker tests become more widely available, then many people could potentially learn about their biomarker results and elevated risk for Alzheimer’s before they have any symptoms.
Given the importance of disclosure issues, a cross-disciplinary group of researchers, doctors, ethicists, counselors, and others have formed the Advisory Group on Risk Evidence Education for Dementia (AGREED). The group’s goal is to evaluate research for increased risk and provide guidance to clinicians on the communication of biomarker and genetic test results that indicate risk for dementia.
This research was supported in part by NIA grants AG016573, P01AG036694, K24 AG035007, P30AG010124, U19AG010483, R01AG063689, U24AG057437, and K01-AG064123.
These activities relate to NIA’s AD+ADRD Research Implementation Milestone 9.M,“Develop diagnostics/biomarkers in asymptomatic individuals.”
References: Grill JD, et al. Short-term psychological outcomes of disclosing amyloid imaging results to research participants who do not have cognitive impairment. JAMA Neurology. 2020. Epub Aug 10. doi: 10.1001/jamaneurol.2020.2734.
Largent EA, et al. Cognitively unimpaired adults’ reactions to disclosure of amyloid PET scan results. PLOS One. 2020;15(2):e0229137. doi: 10.1371/journal.pone.0229137.