Table 7 Characteristics of published randomized controlled trials
From: Clinical trials of new drugs for Alzheimer disease: a 2020–2023 update
Author [Year]; Country | Selection criteria | Number of patients (% male) | Age, year, mean ± SD | Intervention | Duration | Follow up period | Outcome |
|---|---|---|---|---|---|---|---|
Dyck et al. [2023]; United States of America | RCT; patients 50 to 90 years of age with early AD (MCI or mild dementia due to AD) | L: 859 (48.4) P: 875 (47.0) | L: 71.4 ± 7.9 P: 71.0 ± 7.8 | L: 10 mg of intravenous lecanemab per kilogram every 2 weeks P: Placebo | 18 months (79 weeks) | 91 weeks | (1) CDR-SB Score (difference: − 0.45; 95% CI: -0.67 to − 0.23) (2) Amyloid Burden on PET (difference: − 59.1; 95% CI: -62.6 to − 55.6) (3) ADAS-Cog14 Score (MD: − 1.44; 95% CI: − 2.27 to -0.61) (4) ADCOMS (MD: -0.050; 95% CI: − 0.074 to − 0.027) (5) ADCS-MCI-ADL Score (MD: 2.0; 95% CI: 1.2 to 2.8) (6) adverse events (L: infusion-related reactions in 26.4% of participants and amyloid-related imaging abnormalities with edema or effusions in 12.6%.) |
Tahami Monfared et al. [2023]; United States of America | RCT; the same group of patients from Dyck et al | L: 859 (48.4) P: 875 (47.0) | L: 71.4 ± 7.9 P: 71.0 ± 7.8 | L: 10 mg of intravenous lecanemab per kilogram every 2 weeks P: Placebo | 18 months (79 weeks) | 91 weeks | (1) quality-adjusted life-years [L: 4.39 (4.27–4.50); P: 3.68 (3.60–3.77)] (2) mean time to progression to AD dementia [L: 8.64 (7.91–9.57); P: 5.69 (5.32–6.16)] (3) years in institutional care [L: 0.78 (0.69–0.87); P: 0.89 (0.80–0.98)] (4) health outcomes |
Salloway et al. [2021]; Australia, Canada, France, Spain, United Kingdom, and the United States of America | RCT; participants known to have or at-risk for a DIAD mutation-60% asymptomatic | AG: 52 (60) AS: 50 (42) P: 40 (45) | AG: 46.0 ± 10.8 AS: 42.5 ± 9.5 P: 44.2 ± 9.6 | AG: 225 mg of gantenerumab (subcutaneously, every 4 weeks) = > 1,200 mg from year 4 AS: 400 mg of solanezumab (subcutaneously, every 4 weeks) = > 1,600 mg from year 5 | 4–7 years | NA | (1) Digit Symbol scores (2) MMSE scores; (3) Logical Memory scores; (4) ISLT Delayed Recall scores; (5) CDR-SB scores; (6) FAS scores; (7) brain amyloid burden; (8) CSF total Aβ42; (9) CSF phospho-tau181; (10) CSF total tau; (11) CSF NfL |
Bateman et al. [2018]; Australia, Canada, France, Spain, United Kingdom, and the United States of America | RCT; the same group of patients from Salloway et al | AG: 52 (60) AS: 50 (42) P: 40 (45) | AG: 46.0 ± 10.8 AS: 42.5 ± 9.5 P: 44.2 ± 9.6 | AG: 225 mg of gantenerumab (subcutaneously, every 4 weeks) = > 1,200 mg from year 4 AS: 400 mg of solanezumab (subcutaneously, every 4 weeks) = > 1,600 mg from year 5 | 4–7 years | NA | (1) Cognitive composite performance; (2) Proportional hypothetical treatment effects |