Patient‐related benefits of amyloid PET imaging in unclear dementia: rationale and study design of the randomized ENABLE study

Abstract

AbstractBackgroundDementia detection rate is very low in German primary care, as well as internationally. Amyloid PET imaging can reliably clarify an unclear diagnosis of dementia or an uncertain diagnosis of Alzheimer’s Disease (AD), improving diagnostic confidence and patient management. At present, systematic evidence of such benefits is still lacking. The patient‐related benefits of amyloid PET imaging (ENABLE) study will test whether amyloid PET will have a benefit on patients' functional status. Here, we describe the design of ENABLE, a randomized controlled two‐armed coverage with evidence development study in Germany.MethodApproximately 1,126 patients from 20 German academic memory clinics with a clinical diagnosis of mild‐moderate dementia of unclear etiology or of AD with low diagnostic certainty will be included in the study. Those patients will be randomly assigned to amyloid‐PET or routine diagnostics (no amyloid‐PET) (see Figure). The primary endpoint is change from baseline in the ability to perform instrumental activities of daily living (IADL) at 18 months as measured by the Amsterdam IADL Questionnaire. Secondary endpoints include the change in diagnosis, diagnostic confidence, cognition and clinical outcomes of patients and caregivers up until 24 months. We will apply linear and mixed linear models to assess primary and secondary endpoints.ResultWe expect patients' and caregivers' quality of life to be improved after receiving an amyloid PET formal diagnosis, as this will result into timely pharmacological and non‐pharmacological interventions.ConclusionThis study will benefit physicians’ and payers’ decisions on the provision of health care for patients with dementia in Germany.