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Neurodegenerative Disease Parkinson’s Disease


Table 1: Mentation, Behavior, and Mood Parameters in the Unified Parkinson’s Disease Rating Scale 01 2


3 Intellectual impairment None Mild. Consistent forgetfulness with partial Moderate memory loss, Severe memory loss, disorientation, and difficulty with disorientation in


recollection of events but handling complex problems time and space and no other difficulties


impaired handling Thought disorder None Vivid dreaming


‘Benign’ hallucinations with Occasional to frequent insight retained


Depression None


Periods of sadness or guilt Sustained depression greater than normal, but (one week or more) never sustained for days or weeks


Motivation/initiative


Normal Less assertive than usual, Loss of initiative or more passive


Source: Movement Disorder Virtual University, 2008.72


Figure 1: Schematic Diagram of the Attenuation of Disease Progression with Azilect Given Once Daily Trial Design


Efficacy cohort for first primary


endpoint (n=1,164) Early PD


patients not using anti-PD medication (n=1,176)


Rasagiline 1 mg/day Placebo Placebo


Rasagiline 2 mg/day


Randomisation 1:1:1:1


Week -4 0


36 week double-blind, placebo-controlled Phase 1


36


36 week double-blind, active-treatment Phase 2


PD = Parkinson’s disease. Source = adapted from Olanow et al., 2008,39 and Olanow et al., 2009.52


components of these scales depend on subjective rather than objective judgments by the clinician, which may lead to poor inter-rater reliability.18,19 Rating scales and questionnaires should offer inter-observer reliability, test-retest consistency, and internal coherence.20


Disability scales often


measure more constant variables, and have been found to be a more reliable indicator of disability, than clinical rating scales.18,19


As PD is a multidimensional disorder, disease progression and treatment efficacy should be assessed not only through motor symptoms but also through psychopathological and autonomic symptoms. The Unified Parkinson’s Disease Rating Scale (UPDRS) was developed as a brief, valid, and reliable scale for the assessment of activities in PD and has replaced many of the older assessment scales. Furthermore, it includes the patient self-reported Activities of Daily Living (ADL) subscale.21,22


The UPDRS is the


most commonly used subscale for assessing Parkinsonian motoer impairment and disability in clinical trials and within clinical settings.23


92 72


It has been shown to have good-to-excellent inter-rater reliability for speeded repeated movements, resting tremor, rising from a chair, and gait.24


The UPDRS has the advantage of wide use, is applicable across the PD spectrum, and has an almost comprehensive coverage of motor symptoms.22


There is a significant correlation between the UPDRS motor subscale and many neuropsychological tests of cognitive domains.26 Moreover, the UPDRS has been subjected to extensive clinimetric analyses, giving it scientific and clinical credibility.22


Although the widely adopted UPDRS has been reported to have good internal consistency, reliability, and inter-rater reliability,21,27 have been raised about reproducibility on a large scale.22,28


concerns Specifically,


some items in the motor section, including speech and facial expression, have been shown to have a relatively poor inter-rater reliability, while posture, body bradykinesia, action or postural tremor hands, and rigidity have been shown to have moderate inter-rater reliability.24,27


Using the Unified Parkinson's Disease Rating Scale–Activities of Daily Living Subscale to Assess Parkinson’s Disease


More recently, it has been shown that the UPDRS-ADL subscale may be more sensitive when assessing disease progression over time


US NEUROLOGY


To improve inter-rater reliability, training materials, including a video, have been developed by the Movement Disorder Society.25


(n=286) (n=295) (n=293) (n=290)


Efficacy cohort for second and third primaty endpoint who completed Phase 2 (n=996)


Rasagiline 1 mg/day Rasagiline 2 mg/day


(n=228) (n=217) (n=228) (n=237)


It has four subsections, derived from pre-existing scales:22 •


• •


disinterest in elective (non-routine) activities


hallucinations or delusions


Sustained depression with vegetative symptoms


4 Severe memory loss.


Unable to make judgments or solve problems. Requires


much help with personal care. Cannot be left alone Persistent hallucinations, delusions, or florid


without insight. Could interfere psychosis. Not able to care with daily activities


for oneself


Sustained depression with vegetative symptoms and


(insomnia, anorexia, weight suicidal thoughts or intent loss, loss of interest) Loss of initiative or


disinterest in day-to-day (routine activities)


Withdrawn, complete loss of motivation


subsection I: mentation, behavior, and mood (see Table 1); subsection II: Activities of Daily Living (ADL) (see Table 2); subsection III: motor (see Table 3); and • subsection IV: complications.


The UPDRS motor examination parameters are given in Table 3. There are 14 of them: speech, facial expression, tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements, rapid alternating movements of hands, leg agility, arising from a chair, posture, gait, postural stability, and body bradykinesia and hypokinesia.


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