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Rasagiline for mild cognitive impairment in Parkinson's disease: A placebo‐controlled trial
Author(s) -
Weintraub Daniel,
Hauser Robert A.,
Elm Jordan J.,
Pagan Fernando,
Davis Matthew D.,
Choudhry Azhar
Publication year - 2016
Publication title -
movement disorders
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.352
H-Index - 198
eISSN - 1531-8257
pISSN - 0885-3185
DOI - 10.1002/mds.26617
Subject(s) - rasagiline , tolerability , placebo , clinical global impression , parkinson's disease , montreal cognitive assessment , activities of daily living , medicine , psychology , randomized controlled trial , physical therapy , adverse effect , dementia , disease , alternative medicine , pathology
Background This study's aims were to determine the efficacy and tolerability of rasagiline, a selective monoamine oxidase inhibitor B, for PD patients with mild cognitive impairment. Methods Patients on stable dopaminergic therapy were randomized to adjunct rasagiline 1 mg/day or placebo in this 24‐week, double‐blind, placebo‐controlled, multisite study. The primary endpoint was mean change from baseline to week 24 on the Scales for Outcomes of Parkinson's Disease‐Cognition total score. Key secondary measures included changes in cognition, activities of daily living, motor scores, and Clinical Global Impression of Change, as well as safety and tolerability measures. Results Of the 170 patients randomized, 151 (88.2%) completed the study. Change in Scales for Outcomes of Parkinson's Disease‐Cognition scores were not significantly different in the rasagiline and placebo groups (adjusted mean: 1.6 [standard error {SE} = 0.5] vs. 0.8 [SE = 0.5] points; LS means difference = 0.8; 95% confidence interval: −0.48, 2.05; P = 0.22). There were no between‐group differences in change in the MoCA (p=0.84) or Penn Daily Activities Questionnaire ( P = 0.48) scores or in the distribution of Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change modified for mild cognitive impairment ( P = 0.1). Changes in motor (UPDRS part III; P = 0.02) and activities of daily living (UPDRS part II; P < 0.001) scores favored rasagiline. Rasagiline was well tolerated; the most common adverse events in both groups were falls and dizziness. Conclusions Rasagiline treatment in PD patients with mild cognitive impairment was not associated with cognitive improvement. Rasagiline did not worsen cognition, improved motor symptoms and activities of daily living, and was well tolerated in elderly cognitively impaired patients. © 2016 International Parkinson and Movement Disorder Society