Parkinson's Clinical Trial Companion Accelerating Clinical Trials | Page 45

Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) The Unified Parkinson’s Disease Rating Scale (UPDRS) was developed in the 1980s and has become the most widely used clinical rating scale for Parkinson’s disease. A Movement Disorder Society (MDS) sponsored critique in 2001 expanded and revised the scale. The MDS-UPDRS scale is comprised of four key components: I: Non-motor Experiences of Daily Living; II: Motor Experiences of Daily Living; III: Motor Examination; and IV: Motor Complications. 1 MDS-UPDRS PART II Section II of the MDS-UPDRS evaluates the “Motor experiences of daily living.” This includes activities such as eating, sleeping and writing. Section II is comprised of 13 questions and is self- administered by participants, with or without the aid of the caregiver but independently of the investigator. 2 Modified Schwab & England Activities of Daily Living Scale The Modified Schwab & England Activities of Daily Living scale assesses an individual’s ability to function in activities of daily living. The scale ranges from zero to one hundred percent, with one hundred percent indicating a completely independent individual. 3 This assessment is typically conducted as part of a larger exam, such as the MDS-UPDRS. The Montreal Cognitive Assessment (MoCA) Exam The MoCA exam is a rapid screening instrument for mild cognitive dysfunction. It assesses attention, planning and memory skills. The total possible score is 30 points with a score of 26 or higher indicating no dysfunction. Scales for Outcomes in Parkinson’s Disease – Autonomic Dysfunction (SCOPA-AUT) Exam The SCOPA-AUT exam assesses autonomic symptoms in patients with Parkinson’s disease (PD). The questionnaire consists of 25 items assessing the following regions: gastrointestinal, urinary, cardiovascular, thermoregulatory, pupillomotor and sexual dysfunction. 4 Steering Committee Is a group of experts (such as clinical trial investigators, patient advisory groups and sponsor representatives) appointed by a study sponsor to provide overall supervision of a trial and ensure it is being conducted in accordance with the principles of Good Clinical Practice and the relevant regulations. 5 University of Pennsylvania Smell Identification Test (UPSIT) Exam The UPSIT exam assesses an individual’s loss of smell. The test is comprised of forty microencapsulated odorants, which are released by scratching standardized odor-impregnated test booklets. The UPSIT is sensitive to age, gender, smoking habits, and a wide variety of olfactory disorders. 6 https://www.movementdisorders.org/MDS-Files1/PDFs/Rating-Scales/MDS-UPDRS_Vol23_Issue15_2008.pdf https://www.sralab.org/rehabilitation-measures/movement-disorder-society-sponsored-unified-parkinsons-disease-rating-0 3 http://www.virtualhospice.ca/en_US/Main+Site+Navigation/Home/For+Professionals/For+Professionals/Tools+for+Practice/Assessment+tools/ Schwab+_+England+Activities+of+Daily+Living+Scale+(Parkinson_s+Disease).aspx 4 https://www.ncbi.nlm.nih.gov/pubmed/15390007 5 https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm127073.pdf 6 http://theotorhinolaryngologist.co.uk/new/images/pdf/v6_n2/upsit.pdf 1 2 Glossary 43