Session Information
Date: Thursday, June 23, 2016
Session Title: Clinical trials and therapy in movement disorders
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: To evaluate (1) safety and tolerability of ATM and (2) effects of ATM on attention and executive functioning in PD- MCI after 10 weeks of ATM therapy.
Background: PD-MCI is common, but lacks effective treatments. The early loss of norepinephrine-locus ceruleus neurons in PD corresponds with the development of cognitive deficits. We hypothesize that ATM treatment will improve attention and executive functioning in PD-MCI.
Methods: This was a 12-week, double-blind, placebo-controlled study. Subjects with Level I PD-MCI were included and randomized to ATM or placebo. Participants were evaluated at baseline and after 10 weeks of treatment for safety and tolerability, and on a battery of neuropsychological tests measuring facets of attention, information processing speed, set-shifting, and working memory. Study drug was then discontinued, and patients were assessed at a final safety visit. The primary outcome for this study was the Global Treatment effect at 10 weeks of combined neuropsychological tests.
Results: 30 patients were enrolled (average age 67 y, average total UPDRS 46). Baseline performance on neuropsychological tests in both groups was similar. 5 subjects prematurely withdrew. There were no signs of worsening PD severity. The global statistical test (GST) showed that the mean of the summed-ranks for placebo was 117.5 opposed to 99.5 for ATM. The GST yielded a t= -1.18 (DF = 28), two sided p-value=0.25, indicating no group difference on the global measure. Follow-up analyses did not reveal statistically significant differences on any individual neuropsychological tests. However, statistically and clinically significant subjective improvements occurred in the ATM group on subscales for inattention (CAARS A) and impulsivity (CAARS C); no changes occurred in the placebo group.
Conclusions: Treatment with ATM produced subjective (CAARS), but not objective improvements in PD-MCI. It is possible that the subjects in this study were too severely impaired to show change in the selected primary measures. A follow-up study with alternative outcome measures is planned.
To cite this abstract in AMA style:
V.K. Hinson, J. Elm, A. Delambo, T. Turner. A randomized clinical trial of atomoxetine treatment for mild cognitive impairment (MCI) in Parkinson’s disease (PD) [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/a-randomized-clinical-trial-of-atomoxetine-treatment-for-mild-cognitive-impairment-mci-in-parkinsons-disease-pd/. Accessed May 18, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/a-randomized-clinical-trial-of-atomoxetine-treatment-for-mild-cognitive-impairment-mci-in-parkinsons-disease-pd/