Feasibility of clinical trial recruitment for cerebral amyloid angiopathy: A specialist single centre experience

Abstract

Introduction: Cerebral amyloid angiopathy (CAA) is a small vessel disease characterised by vascular amyloid-beta deposition and recurrent intracerebral haemorrhage, for which there are limited data on the practicalities of clinical trial recruitment.

Methods: We describe our single centre recruitment experience for a small biomarker pilot study, which aimed to recruit 10 patients with CAA.

Results: The BOCAA (Biomarkers and Outcomes in Cerebral Amyloid Angiopathy) study recruited 10 CAA patients over 18 months. All patients were recruited from a prospective CAA database (n = 186); the majority of patients (n = 146, 78.5%) were ineligible for the BOCAA study. The most common reasons for exclusion were co-existent cognitive impairment or dementia (n = 42), failure to meet the imaging (modified Boston) criteria (n = 41), and anticoagulant or dual antiplatelet use (n = 18).

Conclusions: Recruitment of CAA patients to a small pilot study is feasible from a single specialist centre; however, centralised multicentre research databases will allow for more effective and co-ordinated recruitment to larger studies. Any future trial will need to consider how best to define mild disease, factors that influence group heterogeneity, and the impact of comorbidities that could limit participation in multimodal testing - but be mindful that more stringent entry criteria will limit recruitment capabilities.

Keywords: Cerebral amyloid angiopathy; Trial recruitment.