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• W2896343373 abstract "This post-hoc analysis from PRIME, an ongoing Phase 1b study evaluating aducanumab in patients (aged 50-90, positive florbetapir PET scan) with prodromal/mild Alzheimer's disease, assessed cognitive and functional domains of the Clinical Dementia Rating (CDR) scale over 24 months, including 12 months from the placebo-controlled period and 12 months from the long-term extension (LTE). During fixed-dose enrollment of the placebo-controlled period of PRIME, patients were randomized to receive fixed doses of aducanumab (1, 3, 6, or 10 mg/kg) or placebo q4w for 52 weeks. A protocol amendment added a cohort of ApoE ε4 carriers receiving aducanumab titrated to 10 mg/kg or placebo. Patients randomized to receive placebo during the placebo-controlled period were assigned in the LTE to aducanumab 3 mg/kg, aducanumab titrated to 6 mg/kg, or aducanumab titrated to 10 mg/kg. Patients randomized to aducanumab 1 mg/kg during the placebo-controlled period received aducanumab 3 mg/kg in the LTE. Patients randomized to aducanumab titrated to 10 mg/kg and all patients randomized to aducanumab fixed doses during the placebo-controlled period continued at their original dose assignments in the LTE. Except safety, LTE endpoints (amyloid PET, CDR-SB, MMSE) were exploratory. Of 196 patients randomized and dosed in PRIME, 143 were dosed in the LTE, and 115 completed treatment at Month 24. Mean (SD) overall baseline CDR-SB score in the PRIME population was 3.17 (1.74), with a cognitive domain score of 2.00 (0.91) and a functional domain score of 1.17 (1.03). At Week 110, adjusted mean changes for cognitive domain scores were 1.47 (in patients switched from placebo to aducanumab in the LTE), 1.76 (in patients switched from 1 mg/kg to 3 mg/kg in the LTE), and 1.13, 1.64, 1.03 and 1.44 (in patients from the 3 mg/kg, 6 mg/kg, 10 mg/kg or titrated aducanumab cohorts that continued aducanumab in the LTE, respectively). Corresponding functional domain scores (adjusted mean change) were 1.77, 1.72, 1.23, 1.34, 0.64, and 1.16. Post-hoc analysis suggests a beneficial effect of aducanumab on cognitive and functional CDR domain scores in patients continuing treatment over 24 months. These data support further investigation of aducanumab in ENGAGE/EMERGE Phase 3 trials." @default.
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• W2896343373 date "2018-07-01" @default.
• W2896343373 modified "2023-10-16" @default.
• W2896343373 title "O1‐09‐06: 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" @default.
• W2896343373 doi "https://doi.org/10.1016/j.jalz.2018.06.2383" @default.
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