Parkinson's Clinical Trial Companion Navigating Clinical Trials - Page 54

Index Adverse event 15, 44 Dyskinesia 10, 19, 24 Intervention 11, 16, 43, 47 Alpha-synuclein 10, 29, 44, 46 Efficacy 8, 10, 45 Interventional trial 16, 17, 47 Arm 44 Eligibility criteria 45 Longitudinal study 47 Baseline data 44 European Medicines Agency (EMA) 8, 10, 46 LRRK2 31, 35, 47 Biomarker 12, 21, 43, 44, 45, 47, 48 Lumbar puncture 17, 47 Precision medicine 10, 31, 39, 48 Pre-clinical 7, 48 Principal investigator 9, 48 Protocol 8, 9, 16, 33, 48 Familial Parkinson’s disease 41, 46 Magnetic Resonance Imaging (MRI) 47 Fox Insight 8, 13, 24, 26, 43 Motor symptoms 7, 21, 25, 26 Recruiting 5, 14, 15, 22, 42, 48 Clinical study 3, 7, 11, 13, 15, 20, 21, 29, 41, 45 Fox Trial Finder 5, 13, 14, 15, 41, 42 Multicenter trial 8, 47 Repurposing 48 Clinical trial 2-3, 7-9, 10, 11, 13, 15-17, 19-21, 23, 31, 34, 40-41, 45 Gaucher disease 46 Neuroprotective treatment 40, 47 SNCA 29, 31, 48 GBA 31, 32, 46 Neuroregenerative treatment 47 Statistical significance 48 Gene 11, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 46 New Drug Application (NDA) 8, 47 Study funder 16, 48 Non-motor symptoms 7, 11, 21, 25 Study sponsor 48 Observational studies 8, 11, 21, 24, 27, 41, 47 Symptomatic therapy 10, 27, 48 Open label 47 Telemedicine 13, 48 Outcome measure 47 Tolerability 48 Patient-reported Outcomes (PROs) 47 Unified Parkinson’s Disease Rating Scale (UPDRS) 49 Placebo 8, 15, 16, 21, 40, 47 U.S. Food and Drug Administration (FDA) 8, 10, 49 Blinding/Blind or “Double-blind” 8, 44, 47 Breakthrough therapy designation 10, 44 Cohort 45 Computed Tomography (CT) Scan 45 Control volunteer 8, 11, 12, 26, 33, 45 Controlled trial 8-9, 45 DaTscan 45 De novo Parkinson’s 21, 45 Deep brain stimulation 2, 4, 24, 26 Digital health (see also telemedicine, virtual study, wearable) 45, 49 Dementia 10, 19, 24 Disease-modifying therapies 8, 10, 20, 21, 45 52 Exclusion criteria 11, 16, 24, 45, 46 Parkinson’s Progression Marker’s Initiative (PPMI) 12, 37, 43 Genetic mutation 30, 31, 32, 33, 34, 37, 38, 39, 46 Genetic counselor 30, 34, 35, 36. 37, 38, 39, 46 Genetic Information Nondiscrimination Act (GINA) 34, 37, 38 Genetic testing 29, 32, 33, 34, 36, 37, 38, 39, 40, 46 Hoehn and Yahr (H&Y) scale 46 Idiopathic Parkinson’s disease 46 Inclusion criteria 11, 16, 24, 46 Informed consent 9, 15, 34, 46 Institutional Review Board (IRB) 9, 46 Navigating Clinical Trials: A Guide for Parkinson’s Patients and Families Placebo-controlled 9, 16, 21, 48 Placebo effect 48 Positron Emission Tomography (PET) scan 48 Randomized 8, 15, 16, 48 Virtual Study 49 Wearable 10, 13, 49