Characterization of exposure–Clinical Dementia Rating–Sum of Boxes relationship in subjects with early Alzheimer’s disease from the aducanumab Phase 3 trials

• Published in: Journal of pharmacokinetics and pharmacodynamics Vol. 50; no. 1; pp. 45 - 62
• Main Authors: Muralidharan, Kumar Kandadi, Kowalski, Kenneth G., Tong, Xiao, Haeberlein, Samantha Budd, Rajagovindan, Rajasimhan, Nestorov, Ivan
• Format: Journal Article
• Language: English
• Published: New York Springer US 01.02.2023; Springer Nature B.V
• Subjects: Alzheimer Disease - drug therapy; Alzheimer's disease; Biochemistry; Biomedical and Life Sciences; Biomedical Engineering and Bioengineering; Biomedicine; Clinical trials; Dementia; Dementia disorders; Disease Progression; Humans; Mental Status and Dementia Tests; Monoclonal antibodies; Neurodegenerative diseases; Original Paper; Pharmacology/Toxicology; Pharmacy; Veterinary Medicine/Veterinary Science; Mixture model; Aducanumab; Alzheimer’s disease; Disease progression; Exposure–response

Clinical Dementia Rating–Sum of Boxes (CDR–SB) assessments from two Phase 3 studies (ENGAGE and EMERGE) of aducanumab in subjects with early Alzheimer’s disease (AD) were pooled to develop an exposure–response (ER) model. A linear model in the logit-transformed scaled CDR–SB best characterized the t...