Outcome measures for dementia with lewy body clinical trials: A review

Background: Dementia with Lewy bodies (DLB) is one of the most common degenerative dementias. Clinical trials for individuals with DLB are increasing. We aimed to identify commonly used outcome measures for trials in DLB. Methods: A pragmatic literature search of PubMed and clinicaltrials.gov identified interventional studies including populations with DLB. Studies were included if they enrolled participants with DLB and met the National Institutes of Health criteria for a clinical trial. Data were collected using standardized forms. Outcome measures were categorized according to core and supportive features of DLB. Results: After de-duplication, 58 trials were identified. The most common cognitive outcome measures were the Mini Mental State Examination (n = 24) and Cognitive Drug Research computerized Assessment System (n = 5). The Clinician’s Assessment of Fluctuations was the most commonly used measure for fluctuations (n = 4). Over half of studies used the Neuropsychiatric Inventory to assess behavioral symptoms (n = 31). The Unified Parkinson’s Disease Rating Scale was frequently used for motor assessment (n = 23). Conclusions and Relevance: Clinical trial outcomes used in DLB are rarely validated in this population and some lack face validity. There is a need to validate existing scales in DLB and develop DLB-specific outcome measures.