Disclosure of Alzheimer’s Disease Biomarker Status in Subjects with Mild Cognitive Impairment

Visser, Pieter Jelle; Wolf, Henrike; Frisoni, Giovanni B.; Gertz, H.-J.

doi:10.2217/bmm.12.58

Cited by 22 publications

(18 citation statements)

References 20 publications

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“…Fourth, our findings reveal how patients’ experiences may not be limited to the expected risks and benefits as described in general literature on amyloid PET disclosure [ 7 , 13 , 43 , 44 ] and IRR disclosure [ 45 – 47 ], and in the information brochure of the clinical trial provided according to the ICH GCP guidelines [ 23 ].…”

Section: Discussionmentioning

confidence: 78%

Amnestic MCI patients’ experiences after disclosure of their amyloid PET result in a research context

et al. 2017

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BackgroundBiomarkers such as amyloid imaging are increasingly used for diagnosis in the early stages of Alzheimer’s disease. Very few studies have examined this from the perspective of the patient. To date, there is only limited evidence about how patients experience and value disclosure in an early disease stage.MethodsSemistructured interviews were carried out with 38 patients with amnestic mild cognitive impairment as part of an investigator-driven diagnostic trial (EudraCT, 2013-004671-12; registered on 20 June 2014) in which participants could opt to know the binary outcome (positive/negative) result of their amyloid positron emission tomography (PET) scan. Verbatim transcripts of the interviews were evaluated using qualitative content analysis and NVivo 11 software.ResultsEight of 38 patients received a positive amyloid PET scan result, and the remaining 30 patients received a negative amyloid PET scan result. After disclosure of the result to the patients, we interviewed each patient twice: 2 weeks after disclosure and 6 months after disclosure. Patients had difficulties in repeating the exact words used during disclosure of their amyloid PET scan result by the neurologist; yet, they could recall the core message of the result in their own words. Some patients were confused by the terminology of an amyloid-positive/negative test result. At 6 months, two of eight patients with a positive amyloid PET scan result experienced emotional difficulties (sadness, feeling worried). Three of 30 patients with a negative amyloid PET scan result started to doubt whether they had received the correct result. Patients reported that they experienced advantages after the disclosure, such as information about their health status, the possibility of making practical arrangements, medication, enjoying life more, and a positive impact on relationships. They also reported disadvantages following disclosure, such as having emotional difficulties, feeling worried about when their symptoms might worsen, the risk of a more patronizing attitude by relatives, and the possibility of a wrong diagnosis.ConclusionsThis exploratory study shows that the majority of patients can accurately recall the information received during disclosure. The experienced advantages and disadvantages reported by our patients depended on the outcome of the result (positive or negative) and the interval of the conducted interview (2 weeks or 6 months after amyloid PET disclosure). Discrepancies were found between patients’ expectations according to the interview prior to amyloid PET disclosure (Vanderschaeghe et al. [Neuroethics. 2017;10:281–97]) and their actual experiences after their amyloid PET disclosure.

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Section: Discussionmentioning

confidence: 78%

Amnestic MCI patients’ experiences after disclosure of their amyloid PET result in a research context

et al. 2017

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“…The focus on education, follow-up, and in-person disclosure highlights the potential benefits of learning from the genetic counselling model, in line with the approach proposed by Harkins and colleagues [ 4 ]. In particular, such models highlight the importance of shared decision making and two-way communication [ 36, 62 ]. However, it is also important to remain cognizant of material differences between ‘state’ and genetic ‘trait’ information [ 28 ], notably the potential for levels of amyloid change over time, and the unclear nature of the relationship between amyloid load and the development of dementia.…”

Section: Discussionmentioning

confidence: 99%

Perspectives on Communicating Biomarker-Based Assessments of Alzheimer’s Disease to Cognitively Healthy Individuals

Milne

Bunnik

Diaz

et al. 2018

JAD

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In clinical trials which target pathophysiological mechanisms associated with Alzheimer’s disease, research participants who are recruited based on biomarker test results should be informed about their increased risk of developing Alzheimer’s dementia. This paper presents the results of a qualitative focus group study of attitudes and concerns toward learning information about biomarker-based risk status among healthy research participants in the United Kingdom and Spain and people with dementia and their supporters/caregivers from countries represented in the European Working Group of People with Dementia of Alzheimer Europe. The study identified expectations related to learning risk status and preferences related to the content, quality, and follow-up of the disclosure process. The latter emphasize distinctions between risk and diagnoses, the importance of clear information about risk, and suggestions for risk reduction, as well as expectations for follow up and support. The implications of these preferences for practice are discussed. Providing details of research participants’ experience and views may serve as a guide for the development of processes for the responsible disclosure of Alzheimer’s disease biomarkers.

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“…21 From an ethical perspective, there is ongoing discussion regarding whether patients in the early stages of AD should be offered the choice of knowing their biomarkerbased diagnosis, despite the current lack of effective treatments. 22 It is, therefore, important to identify and validate biomarkers that reflect the underlying pathology of the disease process. Incorporation of these biomarkers into routine diagnostic testing will depend on ensuring that the corresponding tests exhibit good performance and are reliable, reproducible, noninvasive, simple to perform, and cost effective.…”

Section: Hepatitis Bmentioning

confidence: 99%

Personalized health care beyond oncology: new indications for immunoassay‐based companion diagnostics

Batrla

Jordan

2015

Annals of the New York Academy of Sciences

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Personalized health care (PHC) is an evolving field of medicine aimed at providing the right therapy to the right patient at the right time. This approach often incorporates the use of companion diagnostics (CDx) assays that provide information essential for the safe and effective use of the corresponding drug. In addition to oncology, many other therapy areas, such as cardiovascular, neurological, and infectious and inflammatory diseases, may benefit from PHC, owing to disease complexity and heterogeneity. Furthermore, although most U.S. Food and Drug Administration–approved CDx are based on molecular‐based technologies, immunoassays can provide a significant contribution to the evolution of CDx in patient management. In this review we discuss how the incorporation of biomarker immunoassays into routine diagnostic testing may allow early and definitive detection of Alzheimer's disease and enable population enrichment in clinical trials. In addition, we will describe how biomarker‐based CDx immunoassays have potential utility for stratifying patients with asthma based on their potential response to therapy and for selecting treatment according to phenotypic profile. Continued research into the underlying disease pathology and development of accurate and reliable diagnostic assays may ensure that PHC becomes the future standard for many indications.

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Disclosure of Alzheimer’s Disease Biomarker Status in Subjects with Mild Cognitive Impairment

Cited by 22 publications

References 20 publications

Amnestic MCI patients’ experiences after disclosure of their amyloid PET result in a research context

Amnestic MCI patients’ experiences after disclosure of their amyloid PET result in a research context

Perspectives on Communicating Biomarker-Based Assessments of Alzheimer’s Disease to Cognitively Healthy Individuals

Personalized health care beyond oncology: new indications for immunoassay‐based companion diagnostics

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