Parallel-Group Study to Assess the Effect of Rasagiline on Cognition in Patients With Parkinson's Disease

The SCOPA-COG is scored from 0 to 43 (higher scores reflect better performance). The memory domain consists of 4 items (replicating the order in which cubes were pointed out, digit span backward, immediate and delayed word recall); the attention domain consists of 2 items (counting down by 3 and months backward); the executive functioning domain consists of 3 items (successive repetitions of fist-edge-palm movements, set shifting with dices, and fluency with animals); and the visuospatial functioning domain consists of a single item (mental reconstruction of figures).

All study raters will receive training on how to reliably complete the SCOPA-COG. The same site rater (PI or designee) must complete this scale at all visits.

UPDRS Part 3 (motor examination subscale) comprises 14 items assessing the motor disabilities of the patient at the time of the visit. The patient's speech, facial expressions, ability to arise from a chair (with arms folded), posture, gait, postural stability (retropulsion test), and body bradykinesia and hypokinesia are assessed. In addition, the following evaluations require assessment of the face, neck or extremities: tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements (open and close), rapid alternating movements of hands (pronation and supination), and leg agility (tap heel on ground). This evaluation is performed while the patient is in the on phase.

Each item is assessed on a scale from 0 (normal, absent, or none) to 4 (severe impairment).

The MoCA assesses 8 cognitive areas: visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. Each area is rated and a total score is arrived at; the total score is neither good or bad and is compared to the baseline score to assess an improvement or a decline.

The ADCS MCI-CGIC score is generated in the context of a semistructured interview and is an indication of the change in the patient's global status; the rater will rate Cognition, Behavior, and Functional Abilities all on a 7 point scale with the best score being Marked Improvement and the worst being Marked Worsening.

The UPDRS (Version 3) will be completed at the baseline, Week 4, Week 12, and Week 24 (or early discontinuation) Visits. UPDRS Part 2 (ADL subscale) comprises 13 items evaluating the impact of PD on patients' ADL (in both the on and off states) in the week prior to the visit. The following 13 ADL are assessed: speech, salivation, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene, turning in bed and adjusting bed clothes, falling (unrelated to freezing), freezing when walking, walking, tremor, and sensory complaints related to Parkinsonism.

Each item is rated on a scale from 0 (normal) to 4 (severe impairment).