Mary Easton Center for Alzheimer's Disease Research, UCLA, Los Angeles, CA, USA.
Alzheimers Dement. 2013 May;9(3):356-359.e1. doi: 10.1016/j.jalz.2012.03.001. Epub 2012 Nov 8.
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.
为了确定临床前阿尔茨海默病(AD)临床试验招募的促进因素和障碍,50 名认知正常的参与者在被随机分配到两种假设的 AD 风险情景之一后接受了采访:(1)一般与年龄相关的 AD 风险,或(2)AD 风险增加 50%。参与者对他们是否会参加假设的决策提供了无提示的障碍和促进因素。确定了 13 个促进因素主题和 5 个障碍主题。最常见的障碍与服用研究药物有关的恐惧。那些被随机分配到 AD 风险增加的参与者更频繁地将降低个人风险作为促进因素(P =.01),而较少将时间作为参与的障碍(P =.02)。这些结果表明,临床前 AD 临床试验的招募可能面临挑战,而披露风险信息可能会提高参与率。