Abstract
INTRODUCTION
Amid recent approvals, early Alzheimer’s disease (AD) remains an active area of treatment development.
METHODS
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.
RESULTS
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).
DISCUSSION
Returning additional biomarker results may increase willingness to enroll in early AD trials.
Highlights
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.
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This post is Copyright: Marina Ritchie,
Megan Witbracht,
Eunji Russ,
S. Ahmad Sajjadi,
Gaby T. Thai,
Steven Tam,
Daniel L. Gillen,
Joshua D. Grill | July 28, 2024