Abstract | BACKGROUND: 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:
|
Authors | Daniel Weintraub, Robert A Hauser, Jordan J Elm, Fernando Pagan, Matthew D Davis, Azhar Choudhry, MODERATO Investigators |
Journal | Movement disorders : official journal of the Movement Disorder Society
(Mov Disord)
Vol. 31
Issue 5
Pg. 709-14
(05 2016)
ISSN: 1531-8257 [Electronic] United States |
PMID | 27030249
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
|
Copyright | © 2016 International Parkinson and Movement Disorder Society. |
Chemical References |
- Dopamine Agents
- Indans
- Monoamine Oxidase Inhibitors
- rasagiline
|
Topics |
- Aged
- Cognitive Dysfunction
(drug therapy, etiology)
- Dopamine Agents
(therapeutic use)
- Double-Blind Method
- Drug Therapy, Combination
- Female
- Humans
- Indans
(administration & dosage, pharmacology)
- Male
- Middle Aged
- Monoamine Oxidase Inhibitors
(administration & dosage, pharmacology)
- Outcome Assessment, Health Care
- Parkinson Disease
(complications, drug therapy)
|