UC Irvine Institute for Memory Impairments and Neurological Disorders, University of California, Irvine, California, USA.
Department of Neurobiology and Behavior, University of California, Irvine, California, USA.
Alzheimers Dement. 2024 Sep;20(9):6654-6658. doi: 10.1002/alz.14143. Epub 2024 Jul 27.
Amid recent approvals, early Alzheimer's disease (AD) remains an active area of treatment development.
We performed a conjoint experiment to compare preferences among 26 patients with mild cognitive impairment for four trial features including designs incorporating active aducanumab-control (vs. placebo), returning tau positron emission tomography (PET) results (vs. no disclosure), remote study partner participation (vs. in person), and increased risk of brain swelling (vs. lower risk). We used a generalized estimating equation to model the utility of factor levels.
Returning tau PET results had the highest utility (est: 0.47; 95% confidence interval [CI]: 0.13, 0.81; P = 0.007); remote study partner participation showed a similar trend (est: 0.29; 95% CI: -0.05, 0.63; P = 0.097). Trials with active-controlled design (est: 0.01; 95% CI: -0.33, 0.35; P = 0.956) did not demonstrate utility and higher risk of brain swelling had negative utility (est: -0.64; 95% CI: -0.99, -0.30; P < 0.001).
Returning additional biomarker results may increase willingness to enroll in early AD trials.
We compared mild cognitive impairment participant preferences for four trial design features. Returning tau positron emission tomography results had the highest utility. Remote study partner participation showed a positive, albeit non-significant, trend. No utility was observed for an active aducanumab-control design.
在最近获得批准的情况下,早期阿尔茨海默病(AD)仍然是治疗开发的活跃领域。
我们进行了一项联合实验,比较了 26 名轻度认知障碍患者对四项试验特征的偏好,包括包含活性 aducanumab-对照(与安慰剂相比)、返回 tau 正电子发射断层扫描(PET)结果(与不披露相比)、远程研究伙伴参与(与亲自参与相比)和增加脑肿胀风险(与低风险相比)的设计。我们使用广义估计方程来对因子水平的效用进行建模。
返回 tau PET 结果的效用最高(估计值:0.47;95%置信区间 [CI]:0.13,0.81;P = 0.007);远程研究伙伴参与显示出类似的趋势(估计值:0.29;95% CI:-0.05,0.63;P = 0.097)。具有活性对照设计的试验(估计值:0.01;95% CI:-0.33,0.35;P = 0.956)没有显示出效用,并且脑肿胀风险增加具有负效用(估计值:-0.64;95% CI:-0.99,-0.30;P < 0.001)。
返回额外的生物标志物结果可能会增加参与者参加早期 AD 试验的意愿。
我们比较了轻度认知障碍参与者对四项试验设计特征的偏好。返回 tau 正电子发射断层扫描结果的效用最高。远程研究伙伴参与显示出积极的趋势,但不显著。活性 aducanumab-对照设计没有观察到效用。