Comparison of Eligibility Criteria and Baseline Characteristics Between the Patient Populations of evoke and evoke+, Clarity AD and TRAILBLAZER-ALZ-2
Paul Mystkowski1, Howard Feldman2, Philip Scheltens3, Oskar Hansson4, Mary Sano5, Wiesje van der Flier6, Lars Bardtrum7, Peter Johannsen7, Rose Jeppesen7, Teresa Leon7, Charlotte Thim Hansen7, Jeffrey Cummings8
1Novo Nordisk Inc., 2Alzheimer’s Disease Cooperative Study, Department of Neurosciences, University of California San Diego, 3EQT Life Sciences Partners, 4Clinical Memory Research Unit, Department of Clinical Sciences Malmö and Memory Clinic, Lund University and Skåne University Hospital, 5Icahn School of Medicine at Mount Sinai and James J. Peters VAMC, 6Alzheimer Center Amsterdam, Department of Neurology, Department of Epidemiology and Data Science, Amsterdam Neuroscience,, Amsterdam UMC, Vrije Universiteit Amsterdam, 7Novo Nordisk A/S, 8University of Nevada
Objective:
To compare the evoke and evoke+ trial populations with other phase 3 programs for disease-modifying therapy (DMT) in early Alzheimer’s disease (AD).
Background:
evoke and evoke+ are phase 3, randomized, placebo-controlled trials currently investigating the glucagon-like peptide-1 receptor agonist semaglutide DMT in persons with early AD.
Design/Methods:
We compared the inclusion/exclusion criteria and baseline characteristics of the evoke/evoke+ trial populations with those of Clarity AD (lecanemab) and TRAILBLAZER-ALZ-2 (donanemab): two recent phase 3 trials assessing anti-amyloid monoclonal antibodies in persons with early AD. A descriptive comparison is presented.
Results:
All four trials reported a total randomized sample of 7337 participants (3806 in evoke/evoke+, 1795 in Clarity AD and 1736 in TRAILBLAZER-ALZ-2). The broadest age range was in Clarity AD (50–90 years vs 55–85 years in evoke/evoke+ and 60–85 years in TRAILBLAZER-ALZ-2). Race and ethnicity differed across trials, with the highest absolute number of non-White participants in evoke/evoke+ (741 vs 402 in Clarity AD and 148 in TRAILBLAZER-ALZ-2; US Hispanic participation, 23.6% in evoke/evoke+ vs 11.4% in TRAILBLAZER-ALZ-2). Cognitive inclusion criteria also differed: evoke/evoke+ and Clarity AD required deficits in episodic memory at screening (based on WMS IV–Logical Memory II test and Repeatable Battery for Neuropsychological Status Delayed Memory Index, respectively). All studies required participants to demonstrate amyloid positivity. TRAILBLAZER-ALZ-2 included tau pathology by positron emission tomography (PET) at screening. The TRAILBLAZER-ALZ-2 population had more impairment on CDR-Sum of Boxes, Mini-Mental State Examination and CDR global.
Conclusions:
All four studies targeted biologically defined early-stage AD but differed in cognitive inclusion criteria. Unlike evoke/evoke+ and Clarity AD, TRAILBLAZER-ALZ-2 recruited more patients with impairment and used tau PET for staging. A higher number of non-White participants were included in evoke, evoke+ and Clarity AD vs TRAILBLAZER-ALZ-2. Data for evoke and evoke+ are still subject to cleaning.
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