P630 - DISEASE SPECIFIC GLOBAL CLINICAL RATING SCALES FOR LEWY-BODY DEMENTIA: LITERATURE REVIEW AND CONCEPT IDENTIFICATION (ID 1788)
Abstract
Aims
The 2015 JPND report on harmonizing clinical and biomarker protocols for studies in Lewy-body dementia (LBD) recognized use of the Clinical Dementia Rating (CDR) and Clinical Global Impression, but noted neither is disease specific. It was suggested modifications should address other relevant domains of cognition, attention/wakefulness, psychiatric, motor, and functioning. Literature reviews to identify clinical outcome assessments (COAs) and measurement concepts are one early component of instrument development. We report data to inform iterative COA development.
Methods
Two data sources were used to explore use of COAs in clinical trials and clinical research in LBD. The first was clinicaltrials.gov (CT.gov). The second was a targeted literature review using terms related to COAs and Lewy body disease and dementia.
Results
The search of CT.gov identified 149 clinical trials in dementia with Lewy bodies or Parkinson’s disease dementia. Organized by measurement concepts, the most frequently used COAs were CDR (global; N=12), NPI (behavior/neuropsychological; N=27), MMSE (cognition; N=26). The literature review identified 20,695 results from peer reviewed journals of which the first 100 were selected sorted by relevance. Further filtering left 24 results for detailed evaluation. Again, the CDR (N=4), NPI (N=7), and MMSE (N=13) were prominent in this sample.
Conclusions
Detailed evaluation of measurement concepts within COAs can be used to identify items as a basis for iterative development of global scales such as the CDR and CGI, to create disease specific instruments. Supplementing these data with clinician, patient and caregiver input via qualitative research can then be used to finalize content for psychometric evaluation.
