Real-World Outcomes of Aducanumab Therapy Utilizing The Ohio State University Clinical Guidelines for Anti-Amyloid Therapy 
Truelove J, Kovesci R, Scharre DW, Ramamurthy A, Bouchachi S

Results ❖Anti-amyloid monoclonal antibodies therapies (AAT) offer disease-modifying potential for early Alzheimer’s disease (AD), but real-world data on outcomes and safety using structured clinical guidelines remain limited. ❖In 2021, OSU developed clinical guidelines to standardize patient selection, monitoring, and discontinuation of AAT ❖We report real-world clinical, biomarker, and safety outcomes in patients treated with aducanumab using these guidelinesMethods ❖ 15 patients with mild cognitive impairment (MCI) due to AD or mild AD dementia initiated aducanumab treatment between Aug 2021 and Mar 2022 at OSU’s memory disorders center. ❖ Our guidelines were followed to determine eligibility, treatment management, and discontinuation. ❖ Cognitive and functional assessments (MMSE, SAGE, CDR) were performed every six months. ❖ CSF biomarkers were assessed at baseline and 78 weeks. Long-term clinical follow-up extended to 4 years OSU GUIDELINES ❖AAT OSU Guidelines can be accessed at: https://acrobat.adobe.com/id/urn:aaid:sc:US:01dc1eec-5b11-4735-99f7-1dbf63f36889 ❖After78 weeks, mean declines were 2.6 points on MMSE and 1.2 points on CDR-SB, comparable to the high-dose EMERGE trial cohort. ❖At four years, 42% of those starting as MCI due to AD or Mild AD remained at these stages. ❖ARIA occurred in 33.3% of patients, consistent with clinical trial rates; most cases were mild and asymptomatic, with one severe case leading to discontinuation at week 12. ❖CSFbiomarkersdemonstratedtreatmenteffect, including an average 30.5% increase in Aβ42, 48.7% reduction in p-tau, and 69.2% reduction in p-tau/Aβ42 ratio. Pre-infusion and post 78 weeks aducanumab CSF biomarker levels, n=9 Pre-infusion and post 78 weeks MMSE, SAGE, and CDR-SB scores, n=13 Demographics Cohort size (n) Gender (%female) Mean age at time of prescription (years) Mean years from symptom onset MCI due to AD diagnosis, n (%) Mild AD dementia diagnosis n (%) Moderate AD dementia diagnosis n (%) Severe AD dementia diagnosis n (%) Baseline Week 78 4 Years 15 53 74.0 4.0 10 (67) 5 (33) 0 (0) 0 (0) Oral cognitive symptomatic therapy n (%) 14 (93) Education, average years (%) 15.1 CSF Biomarkers, Mayo Clinic, n Average Abeta42 level, pg/mL Average P-Tau level, pg/mL Average T-Tau level, pg/mL Average P-Tau to Abeta42 ratio Cognitive test scores/CDR, n Average MMSE score/30 Average SAGE score/22 9 930.9 61.6 386.1 0.044 13 26.2 15.2 13 6 (46) 5 (39) 2 (15) 0 (0) 9 1214.6 31.6 337.0 0.026 13 23.6 13.3 12 4 (33) 1 (8) 6 (50) 1 (8) 12 20.5 12.8 (n=7) Average CDR Sum of Boxes Average CDR Global 3.0 0.6 4.2 0.7 6.9 1.2 Conclusion ❖Application of structured clinical guidelines enabled safe and effective real-word use of aducanumab. ❖These 4-year clinical follow-up findings support the utility of standardized guidelines for optimizing outcomes with anti-amyloid therapies in clinical practice. ❖Our comprehensive guidelines can be utilized by other institutions to guide widespread, safe, and effective use of anti-amyloid therapies. OSU Guidelines may be used for noncommercial educational and noncommercial (NOT funded by a commercial entity) research use only. These guidelines are OSU Intellectual Property and as such all copyright rights are reserved and guidelines cannot be reproduced, distributed, displayed, used, or have derivative works created without express permission from OSU