Prospective multicenter cohort study: Validation of different biomarkers for Lewy body dementia in the prospective E-DLB cohort.
This is an open study for all centers in the European-Dementia of Lewy body consortium. The study involves collection of clinical data and biomarker collection to be used for central analysis (see inclusion and exclusion criteria in table 1). The main aim is to explore and validate diagnostic and prognostic biomarkers for Lewy body dementia. Studies involving role and features of imaging biomarkers (MRI, FDG PET and DAT SPECT) in DLB patients have been carried out so far in the E-DLB. As well as EEG analysis and bio fluid recollection. Standard Operating Procedures for MRI, SPECT, PET-FDG and EEG are available for all E-DLB members.
Choosing the clinical procedures for DLB on the other hand, is challenging task since clinicometric data are usually not available in DLB. For the longitudinal assessment of several domains, including cognitive and psychiatric symptoms, we have provided a basic Level 1, and a more advanced Level 2 and 3 (see table 2). For biomarkers, again we have provided recommendations Sample Collection, Handling and Storage. The recommendations are summarized in the table 3 below.
*Orthostatic blood pressure and pulse measurements in supine position after 5 min´s rest, immediately after standing, after 1 and 3 minutes. Selected items from NMSS: Constipation (#21) and urinary symptoms (# 22-23).
Abbreviations:
CDR: Clinical Dementia Rating; MMSE: Mini-Mental State Examination; MOCA: Montreal Cognitive Assessment Scale; MADRS: The Montgomery- Asberg Depression Rating Scale, CERAD: Consortium to Establish a Registry for Alzheimer’s Disease; VOSP: Visual Object and Space Perception Battery; WAIS: Wechsler Adult Intelligence Scale; NPI: Neuropsychiatric Inventory; GDS: Geriatric Depression Scale; NEVI: North-East Visual hallucinations Inventory; NMSS: Non-Motor Symptom Scale; ECG: Electrocardiogram; MDS- UPDRS: Movement Disorder Society Unified Parkinson’s Disease Rating Scale; UPDRS-m Modified Unified Parkinson’s Disease Rating Scale, HADS: Hospital Anxiety and Depression Scale; IQCODE: Informant Questionnaire for Cognitive Decline in the Elderly; EQ5D: The EuroQol Group quality of life scale, SF36: Health Survey, UPSIT: The University of Pennsylvania Smell Identification Test.