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Randomized Controlled Trial
. 2013 May;9(3):356-359.e1.
doi: 10.1016/j.jalz.2012.03.001. Epub 2012 Nov 8.

Risk disclosure and preclinical Alzheimer's disease clinical trial enrollment

Affiliations
Randomized Controlled Trial

Risk disclosure and preclinical Alzheimer's disease clinical trial enrollment

Joshua D Grill et al. Alzheimers Dement. 2013 May.

Abstract

To identify the facilitators and barriers to preclinical Alzheimer's disease (AD) clinical trial recruitment, 50 cognitively normal participants were interviewed after being randomized to one of two hypothetical AD risk scenarios: (1) the general age-related risk for AD, or (2) being at 50% increased risk for AD. Participants provided uncued barriers and facilitators to the hypothetical decision of whether they would enroll. Thirteen themes of facilitators and five themes of barriers were identified. The most common barrier was fear related to taking study drug. Those randomized to being at increased risk for AD more frequently cited lowering personal risk as a facilitator (P = .01) and less frequently cited time as a barrier to enrollment (P = .02). These results suggest potential challenges to preclinical AD clinical trial recruitment and that disclosing risk information may enhance enrollment.

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References

    1. Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, Iwatsubo T, Jack CR, Jr, Kaye J, Montine TJ, et al. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7:280–292. - PMC - PubMed
    1. Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, et al. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011;7:270–279. - PMC - PubMed
    1. Baca CB, Cheng EM, Spencer SS, Vassar S, Vickrey BG. Racial differences in patient expectations prior to resective epilepsy surgery. Epilepsy Behav. 2009;15:452–455. - PMC - PubMed
    1. Ryan GW, Bernard HR. Techniques to identify themes. Field Methods. 2003;15:85–109.
    1. Grill JD, Karlawish J. Addressing the challenges to successful recruitment and retention in Alzheimer's disease clinical trials. Alzheimers Res Ther. 2010;2:34. - PMC - PubMed

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