|The following article is part of conference coverage from the 2018 Alzheimer’s Association International Conference in Chicago, Illinois. Neurology Advisor’s staff will be reporting breaking news associated with research conducted by leading experts in neurology. Check back for the latest news from AAIC 2018.|
CHICAGO — Data from a post-hoc analysis of the PRIME study demonstrated a beneficial effect of aducanumab on cognitive and functional scales in patients who continued to receive treatment for over 2 years. The data were presented at the 2018 Alzheimer’s Association International Conference, July 22-26, 2018 in Chicago, Illinois.
PRIME is an ongoing phase 1b study that includes adults aged 50 to 90 years with a positive florbetapir PET scan who have prodromal/mild Alzheimer disease. They are being evaluated on cognitive and functional domains of the Clinical Dementia Rating (CDR) scale over 24 months, which include 12 months from the placebo-controlled period and 12 months from the long-term extension (LTE) phase.
Study patients received aducanumab 1mg/kg, 3mg/kg, 6mg/kg, 10mg/kg or placebo every 4 weeks for 52 weeks during the fixed-dose enrollment of the placebo-controlled phase. A population of patients who were ApoE ε4 carriers were added to the study and were titrated to aducanumab 10mg/kg. Those who were randomized to placebo initially were assigned to aducanumab 3mg/kg or titrated to 6mg/kg or 10mg/kg in the LTE. Those who received aducanumab 1mg/kg in the initial period received 3mg/kg in the LTE; the remaining patients at 10mg/kg and fixed doses continued their original doses in the LTE.
A total of 115 patients of the 143 dosed in the LTE completed treatment at month 24. The average overall baseline CDR-SB score in the PRIME population was 3.17 with a cognitive domain score of 2.00 and a functional domain score of 1.17. For patients who switched from placebo to aducanumab in the LTE, they had an adjusted change of 1.47 in the cognitive domain scores at week 110. Similarly, an adjusted mean change of 1.76 was seen for patients who switched from 1mg/kg to 3mg/kg in the LTE, a change of 1.13 in the titrated 3mg/kg cohort, a change of 1.64 in the titrated 6mg/kg cohort, a change of 1.03 in the titrated 10mg/kg cohort, and a change of 1.44 in the aducanumab cohorts that continued on their dose. Changes in the functional domain scores were 1.77, 1.72, 1.23, 1.34, 0.64, and 1.16, for the treatment arms, respectively.
The findings suggest a positive effect on cognitive and functional domain scores among patients receiving aducanumab over 24 months. “These data support further investigation of aducanumab in ENGAGE/EMERGE phase 3 trials,” the authors noted.
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Haeberlein SB, Castrillo-Viguera C, Gheuens S, et al. 24-month analysis of change from baseline in clinical dementia rating scale cognitive and functional domains in PRIME, a randomized phase 1b study of the anti-amyloid beta monoclonal antibody aducanumab. Presented at: 2018 Alzheimer’s Association International Conference. July 22-26, 2018; Chicago, IL. Oral presentation O1-09-06.