A randomized controlled trial of amyloid positron emission tomography results disclosure in mild cognitive impairment

Lingler, Jennifer H.; Sereika, Susan M.; Butters, Meryl A.; Cohen, Ann D.; Klunk, William E.; Knox, Melissa; McDade, Eric; Nadkarni, Neelesh K.; Roberts, J. Scott; Tamres, Lisa K.; López, Oscar L.

doi:10.1002/alz.12129

Cited by 20 publications

(52 citation statements)

References 18 publications

(18 reference statements)

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“…That the majority of participants enrolled with a spouse study partner is consistent with AD dementia trials 5,16 and other MCI research. [17][18][19][20] The current data do not explain the apparent recruitment bias. It is possible that MCI participants lacking a spouse may have been differentially excluded.…”

Section: Discussioncontrasting

confidence: 80%

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Dyadic Enrollment in a Phase 3 Mild Cognitive Impairment Clinical Trial

Hakhu¹,

Gillen²,

Grill³

2022

Alzheimer Disease &Amp; Associated Disorders

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Background: Dyadic enrollment of a participant and study partner is required in mild cognitive impairment (MCI) clinical trials, despite participants being functionally independent. Research examining how the study partner requirement impacts MCI trials remains limited. Methods: Using the Alzheimer’s Disease Cooperative Study donepezil and vitamin E MCI trial data, we quantified the proportions of enrolled spouse, adult child, and other dyads. We used multinomial regression to identify which baseline participant characteristics (age, sex, race and ethnicity, apolipoprotein E ε4 status, education, residence type) were associated with dyad type. Results: Among 769 randomized dyads, 73% were spousal, 14% adult child, and 13% other dyads. Adjusting for multiple comparisons, underrepresented racial and ethnic background (eg, comparing Hispanic to non-Hispanic White participants: adult child vs. spouse odds ratio = 5.86; 95% confidence interval: 2.09, 16.5; other vs. spouse odds ratio = 4.95; 95% confidence interval: 1.83, 13.4), female sex, age, nonhouse residence, and apolipoprotein E ε4 noncarriage were each associated with a higher odds of having an adult child, as well as an other, study partner at enrollment. Discussion: Increasing participation among nonspousal dyads may facilitate more inclusive and representative MCI trial samples.

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Section: Discussioncontrasting

confidence: 80%

“…That the majority of participants enrolled with a spouse study partner is consistent with AD dementia trials5,16 and other MCI research 17–20. The current data do not explain the apparent recruitment bias.…”

Section: Discussionsupporting

confidence: 75%

Dyadic Enrollment in a Phase 3 Mild Cognitive Impairment Clinical Trial

Hakhu¹,

Gillen²,

Grill³

2022

Alzheimer Disease &Amp; Associated Disorders

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Section: Discussionmentioning

confidence: 99%

“…13,14 An emerging body of literature on disclosure of amyloid neuroimaging also provides guidance for responsible return of biomarker results in both asymptomatic and symptomatic populations. [15][16][17] A wide range of health professionals was involved in disclosure of results, including physicians, psychologists, nurses, genetic counselors, and research staff. Neurologists were the most commonly involved type of health professional, reflecting their expertise related to diagnostic and biomarker information pertinent to dementia, as well as their ADRC leadership roles and regular involvement in longitudinal cohort study visits.…”

Section: Disclosure Process Featuresmentioning

confidence: 99%

Disclosure of individual research results at federally funded Alzheimer's Disease Research Centers

Roberts

Ferber

Blacker

et al. 2021

A&D Transl Res & Clin Interv

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Introduction This study describes practices for disclosing individual research results to participants in Alzheimer's disease research. Methods An online survey of clinical core leaders at National Institutes of Health‐funded Alzheimer's Disease Research Centers in the United States (response rate: 30/31, 97%) examined return of results practices across nine different types of research results. Results Most centers had returned consensus research diagnoses (83%) and neuropsychological test results (73%), with fewer having shared amyloid positron emission tomography (43%), tau imaging (10%), or apolipoprotein E ( APOE ) genotype (7%) results. Centers reported having disclosed a mean of 3.1 types of results (standard deviation = 2.1; range 0–8). The most commonly cited reason for disclosure was to inform participants’ medical decision‐making (88%). Disclosure involved multiple professionals and modalities, with neurologists (87%) and in‐person visits (85%) most commonplace. Discussion Centers varied widely as to whether and how they disclosed research results. Diagnostic and cognitive test results were more commonly returned than genetic or biomarker results.

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“…Yet, memory clinic experience, particularly with regards to MCI, is informative for BHSs [ 45 ]. A recent randomized clinical trial (RCT) among individuals with mild cognitive impairment (MCI), showed that receiving information on one’s amyloid-PET status did not improve understanding of the MCI diagnosis nor the capacity to cope with the uncertainty inherent to that diagnosis [ 46 ]. Still, the recently published practice guideline by the American Academy of Neurology (AAN) states that an accurate diagnosis of MCI is important, especially to discuss the prognostic possibilities, i.e., risk of dementia [ 47 ].…”

Section: Evidence On Communicating Dementia Riskmentioning

confidence: 99%

Dementia risk communication. A user manual for Brain Health Services—part 3 of 6

et al. 2021

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Growing evidence suggests dementia incidence can be reduced through prevention programs targeting risk factors. To accelerate the implementation of such prevention programs, a new generation of brain health services (BHS) is envisioned, involving risk profiling, risk communication, risk reduction, and cognitive enhancement. The purpose of risk communication is to enable individuals at risk to make informed decisions and take action to protect themselves and is thus a crucial step in tailored prevention strategies of the dementia incidence. However, communicating about dementia risk is complex and challenging.In this paper, we provide an overview of (i) perspectives on communicating dementia risk from an ethical, clinical, and societal viewpoint; (ii) insights gained from memory clinical practice; (iii) available evidence on the impact of disclosing APOE and Alzheimer’s disease biomarker test results gathered from clinical trials and observational studies; (iv) the value of established registries in light of BHS; and (v) practical recommendations regarding effective strategies for communicating about dementia risk.In addition, we identify challenges, i.e., the current lack of evidence on what to tell on an individual level—the actual risk—and on how to optimally communicate about dementia risk, especially concerning worried yet cognitively unimpaired individuals. Ideally, dementia risk communication strategies should maximize the desired impact of risk information on individuals’ understanding of their health/disease status and risk perception and minimize potential harms. More research is thus warranted on the impact of dementia risk communication, to (1) evaluate the merits of different approaches to risk communication on outcomes in the cognitive, affective and behavioral domains, (2) develop an evidence-based, harmonized dementia risk communication protocol, and (3) develop e-tools to support and promote adherence to this protocol in BHSs.Based on the research reviewed, we recommend that dementia risk communication should be precise; include the use of absolute risks, visual displays, and time frames; based on a process of shared decision-making; and address the inherent uncertainty that comes with any probability.

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A randomized controlled trial of amyloid positron emission tomography results disclosure in mild cognitive impairment

Cited by 20 publications

References 18 publications

Dyadic Enrollment in a Phase 3 Mild Cognitive Impairment Clinical Trial

Dyadic Enrollment in a Phase 3 Mild Cognitive Impairment Clinical Trial

Disclosure of individual research results at federally funded Alzheimer's Disease Research Centers

Dementia risk communication. A user manual for Brain Health Services—part 3 of 6

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