156 POTENTIAL ELIGIBILITY FOR ADUCANUMAB THERAPY IN A REGIONAL SPECIALIST MEMORY SERVICE UTILISING AD PHENOTYPE, CSF BIOMARKERS AND APPROPRIATE USE CRITERIA. (18th November 2021)

• Record Type: Journal Article
• Authors: Dolphin, H; O'Dowd, S; Kennelly, S P
• Is Part Of: Age and ageing. Volume 50(2021)Supplement 3
• Publication Date: 2021-11-18
• Subjects: Aging -- Periodicals; Geriatrics -- Periodicals; 618.97
• DOI: 10.1093/ageing/afab219.156
• Languages: English
• ISSNs: 0002-0729

Abstract

Abstract: Background: Aducanumab, the first monoclonal antibody directed against amyloid beta peptide has recently been licensed for use by the FDA for treatment of patients with mild cognitive impairment (MCI) due to Alzheimer's Disease (ad ) or mild ad dementia. Appropriate use criteria (AUC) for Aducanumab have recently been released. In light of these AUC, the aim of this study was to review patients in our specialist memory service with positive CSF biomarkers for ad [low amyloid- beta-42 (AB-42), high phosphorylated tau (p-tau)] to assess their hypothetical eligibility for Aducanumab therapy. Methods: Retrospective database analysis was undertaken of patients with positive (high p-tau, low AB-42) ad -biomarker CSF analysis. Demographic, neuropsychological performance, neuro-radiological, laboratory, and clinical phenotype diagnosis data were reviewed at time of CSF analysis to determine hypothetical eligibility for Aducanumab. Data was extracted and analysed using SPSS v.25. Results: Forty-nine patients had positive ad -CSF biomarkers, 41/49 (84%) of whom presented with common ad phenotypes. 28/49 (57%) were male. Mean patient age was 71.2 (±5.9) RBANS delayed memory index score mean was 80.2 (±14.5) and mean EXIT-25 scores were 13.2 (±6.7). 63.2% (31/49) patients met eligibility criteria for Aducanumab therapy by AUC guidelines. 12.2% (6/49) wouldn't have qualified due to abnormal laboratory findings and 14.2% (7/49) due to MMSE <21 or MoCA <17. Two patients would not have qualified due to underlying medical conditions and two were prescribed therapeutic anticoagulation. However by FDA guidelines, a further 30.6% (15/49) of patients may have been unsuitable due to global Clinical Dementia Rating Scale ≥0.5. Conclusion: AUC for Aducanumab address some of the controversial aspects in its licencing. This report highlights the presence of patients eligible for Aducanumab therapy should a European licence be granted, and the need to develop a system readiness and capacity to deliver this and other emerging disease-modifying ad therapies.