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

Grill, Joshua D.; Raman, Rema; Ernström, Karin; Sultzer, David L.; Burns, Jeffrey M.; Donohue, Michael C.; Johnson, Keith A.; Aisen, Paul S.; Sperling, Reisa A.; Karlawish, Jason; Team, A Study

doi:10.1001/jamaneurol.2020.2734

Cited by 59 publications

(104 citation statements)

References 45 publications

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“…Specifically, both amyloid groups demonstrated increased scores for Item 7 (" To confirm the feeling that I might already be developing symptoms of Alzheimer’s disease dementia ”), whereas only those with not elevated amyloid demonstrated increased scores in Item 2 (" To put my mind at ease if I found out I do not have elevated amyloid on my PET scan ”), while those with elevated amyloid saw an average decrease in score for this item. Previously published results agree with this finding: participants with elevated amyloid similarly demonstrated no change on the FTP scale after biomarker disclosure 6 . In the SOKRATES study, participants learning an elevated amyloid result felt that the result validated their memory concerns, compared to participants with not elevated amyloid who reinterpreted memory concerns as normal aging 9 .…”

Section: Discussionsupporting

confidence: 62%

“…Although participants with not elevated amyloid did not increase their endorsement of Planning/Preparation as much as those with elevated amyloid, they did demonstrate an absolute increase in endorsement of these items. It is possible that this could have been in response to planning for a future that was less likely to include dementia, since it has been shown that these participants also demonstrated an increase in Future Time Perspective (FTP) scale score 6 …”

Section: Discussionmentioning

confidence: 99%

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Reasons for undergoing amyloid imaging among cognitively unimpaired older adults

Ryan

Gillen

Grill

2021

Ann Clin Transl Neurol

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Objectives Preclinical Alzheimer’s disease (AD) clinical trials screen cognitively unimpaired older adults for biomarker criteria and disclose their results. We examined whether participants in the Anti‐Amyloid Treatment in Asymptomatic Alzheimer’s disease Study with “elevated” and “not elevated” amyloid differed in scores on the “Views and Perceptions of Amyloid Imaging” questionnaire. We hypothesized that, prior to disclosure, those with elevated amyloid would score higher than those with not elevated amyloid. We also quantified how responses changed after result disclosure. Methods We assessed data from 4327 individuals who completed the questionnaire at screening visit 1 and after amyloid disclosure. We used linear regression models to assess the relationship between questionnaire category scores and amyloid status. We also quantified the relationship between category score changes and amyloid status. Results Overall, participants scored altruism and contribution to research as the strongest motivations for undergoing amyloid imaging. Those with elevated amyloid scored 0.23 points higher in the Perceived Risk category, on average, than those who had not elevated amyloid prior to disclosure; this effect attenuated towards zero after adjusting for Cognitive Function Instrument score. After disclosure, participants with elevated amyloid demonstrated less within‐subject change in Perceived Risk, on average, compared to those with similar pre‐disclosure scores who had not elevated amyloid, while demonstrating greater changes in the altruism and planning categories. Interpretation Altruism and learning disease risk motivated enrollment in this preclinical AD trial. Participants with elevated amyloid differed from their not elevated counterparts in their perceptions of amyloid imaging, even before undergoing the procedure.

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Section: Discussionsupporting

confidence: 62%

Section: Discussionmentioning

confidence: 99%

Reasons for undergoing amyloid imaging among cognitively unimpaired older adults

Ryan

Gillen

Grill

2021

Ann Clin Transl Neurol

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“…In the absence of unique interventions to modify disease risk, there is a concern that full disclosure may lead to unnecessary worry or anxiety. Counter to this, a recent study on disclosing abnormal amyloid imaging, a biomarker of Alzheimer’s disease risk, to cognitively healthy older adults did not find a short-term effect on depression or anxiety symptoms or suicidal ideation [ 28 ]. However, this study excluded from disclosure those with moderate to severe depression or anxiety symptoms or history of suicidal ideation [ 28 ], and these are the patients who may have the most severe adverse outcomes from disclosure.…”

Section: Disclosure Of Neurodegeneration Risk In Irbdmentioning

confidence: 99%

“…Counter to this, a recent study on disclosing abnormal amyloid imaging, a biomarker of Alzheimer’s disease risk, to cognitively healthy older adults did not find a short-term effect on depression or anxiety symptoms or suicidal ideation [ 28 ]. However, this study excluded from disclosure those with moderate to severe depression or anxiety symptoms or history of suicidal ideation [ 28 ], and these are the patients who may have the most severe adverse outcomes from disclosure. In those at risk for Alzheimer’s disease, about 20% in one study indicated a desire to pursue physician-assisted death if they become cognitively impaired [ 29 ].…”

Section: Disclosure Of Neurodegeneration Risk In Irbdmentioning

confidence: 99%

REM Sleep Behavior Disorder as a Pathway to Dementia: If, When, How, What, and Why Should Physicians Disclose the Diagnosis and Risk for Dementia

Malkani

Wenger

2021

Curr Sleep Medicine Rep

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Purpose of Review People with isolated REM (rapid eye movement) sleep behavior disorder (iRBD) have a high lifetime risk of developing a neurodegenerative disease, including dementia, but disclosure of this risk remains controversial. Herein, we summarize this controversy and provide guidance on disclosure. Recent Findings Neurodegeneration risk disclosure in iRBD is controversial because of a long latency to disease onset and a lack of preventative strategies. Balancing the relevant ethical principles of beneficence, nonmaleficence, and autonomy is challenging. Although there are few data on disclosure in iRBD, evidence from discussing risk in other diseases with dementia provides some guidance. Summary We provide an approach to risk disclosure for patients with iRBD. Patients should be asked if they want to know about future risks. If so, disclosure should be patient centered, focusing on what might happen. Discussion should occur early to give patients time to prepare for the future and consider participating in research.

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“…This requirement has been reported to be a greater barrier for Black participants than their White counterparts 21 and is concordant with observations in AD dementia trials, where Hispanic and non-White participants are more likely to have nonspouse study partners (eg, caregivers). 32 Increased understanding of the attitudes of multiethnic groups toward the study partner requirement, as well as toward other unique aspects of participating in preclinical AD trials (eg, the requirement of amyloid biomarker disclosure 33 ), should be prioritized to improve study designs and recruitment efforts.…”

Section: Quantify Site and Central Recruitment Efforts And Costsmentioning

confidence: 99%

Disparities by Race and Ethnicity Among Adults Recruited for a Preclinical Alzheimer Disease Trial

et al. 2021

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IMPORTANCE Underrepresentation of many racial/ethnic groups in Alzheimer disease (AD) clinical trials limits generalizability of results and hinders opportunities to examine potential effect modification of candidate treatments.OBJECTIVE To examine racial and ethnic differences in recruitment methods and trial eligibility in a multisite preclinical AD trial. DESIGN, SETTING, AND PARTICIPANTSThis cross-sectional study analyzed screening data from the Anti-Amyloid in Asymptomatic AD study, collected from April 2014 to December 2017.Participants were categorized into 5 mutually exclusive ethnic/racial groups (ie, Hispanic, Black, White, Asian, and other) using participant self-report. Data were analyzed from May through December 2020 and included 5945 cognitively unimpaired older adults between the ages of 65 and 85 years screened at North American study sites. MAIN OUTCOMES AND MEASURESPrimary outcomes included recruitment sources, study eligibility, and ineligibility reasons. To assess the probability of trial eligibility, regression analyses were performed for the likelihood of being eligible after the first screening visit involving clinical and cognitive assessments. RESULTSScreening data were included for 5945 participants at North American sites (mean [SD] age, 71.7 [4.9] years; 3524 women [59.3%]; 5107 White [85.9%], 323 Black [5.4%], 261 Hispanic [4.4%], 112 Asian [1.9%], and 142 [2.4%] who reported race or ethnicity as other). Recruitment sources differed by race and ethnicity. While White participants were recruited through a variety of sources, site local recruitment efforts resulted in the majority of Black (218 [69.2%]), Hispanic (154 [59.7%]), and Asian (61 [55.5%]) participants. Participants from underrepresented groups had lower mean years of education (eg, mean [SD] years: Hispanic participants, 15.5 [3.2] years vs White participants, 16.7 [2.8] years) and more frequently were women (226 [70.0%] Black participants vs 1364 [58.5%] White participants), were unmarried (184 [56.9%] Black participants vs 1364 [26.7%] White participants), and had nonspousal study partners (237 [73.4%] Black participants vs 2147 [42.0%] White participants). They were more frequently excluded for failure to meet cognitive inclusion criteria (eg, screen failures by specific inclusion criteria: 147 [45.5%] Black participants vs 1338 [26.2%] White participants). Compared with White participants, Black (odds ratio [OR], 0.43;95% CI, 0.34-0.54; P < .001), Hispanic (OR, 0.53; 95% CI, 0.41-0.69; P < .001), and Asian participants (OR, 0.56; 95% CI, 0.38-0.82; P = .003) were less likely to be eligible after screening visit 1.CONCLUSIONS AND RELEVANCE Racial/ethnic groups differed in sources of recruitment, reasons for screen failure, and overall probability of eligibility in a preclinical AD trial. These results highlight (continued) Key Points Question Are there racial/ethnic differences associated with recruitment sources and reasons for ineligibility among preclinical Alzheimer disease clinical trial participants? Findings In th...

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

Cited by 59 publications

References 45 publications

Reasons for undergoing amyloid imaging among cognitively unimpaired older adults

Reasons for undergoing amyloid imaging among cognitively unimpaired older adults

REM Sleep Behavior Disorder as a Pathway to Dementia: If, When, How, What, and Why Should Physicians Disclose the Diagnosis and Risk for Dementia

Disparities by Race and Ethnicity Among Adults Recruited for a Preclinical Alzheimer Disease Trial

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