Objective: This study aimed to demonstrate effectivity and safety of rotigotine transdermal patch (RTP) on motor and cognitive dysfunctions in patients with Parkinson’s disease with dementia (PDD) and dementia with Lewy bodies (DLB).

Background: Utility of dopamine agonists (DAs) for PDD/DLB patients and their effects on cognitive dysfunction have not been elucidated because the previous RCTs of DAs have excluded demented patients. Daytime sleepiness and behavioral/psychological symptoms of dementia (BPSD) occur frequently and discourage use of DAs in PDD/DLB. A new non-ergot DA, rotigotine, has a similar receptor affinity profile to that of ergot DAs which induce daytime sleepiness less frequently than non-ergot DAs. Rotigotine is applied once daily using a transdermal patch, providing continuous drug delivery and stable drug concentration for 24 hours, and is generally safe and well tolerated in PD patients. RECOVER study (Trenkwalder C, et al., 2011) has demonstrated that RTP improves both early-morning motor function and nocturnal sleep disturbances in PD patients.

Methods: An open-label study. The subjects were patients with PDD/DLB with parkinsonism who needed improvement in motor dysfunctions. Primary outcomes which are cognitive functions by MMSE, MoCA, and ADAS-cog, BPSD by NPI-Q, and daytime sleepiness by Epworth Sleepiness Scale (ESS), were examined before and after RTP treatment.

Results: The subjects (n=6, age 79±5, H&Y 3.5±1.1; M±SD) were treated with RTP 4-6 mg / 24 hours for 60±42 days. Motor improvement occurred in 67% of the subjects. Total scores of MMSE (18.8±3.6 at baseline), MoCA (12.0±4.4), ADAS-cog (20.1±8.6), NPI-Q (severity 4.5±4.7, caregiver distress 5.3±6.6) and ESS (8.0±2.5) did not change after RTP (19.0±3.5, 12.5±3.8, 19.8±8.9, 4.5±4.8, 4.0±5.3, 11.7±3.7, respectively). Executive function by MoCA tended to improve after RTP (from 0.5±0.8 to 1.3±0.5, p=0.06). Scores of the other 5 cognitive domains by MoCA did not change after RTP.

Conclusions: A new non-ergot DA, RTP, is effective in improving motor symptoms in PDD/DLB patients without worsening dysfunctions in any cognitive domains, BPSD or daytime sleepiness. RTP may improve executive function of PDD/DLB patients which is related to dopamine deficiency in the brain.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/effectivity-and-safety-of-rotigotine-transdermal-patch-on-motor-and-cognitive-dysfunctions-in-parkinsons-disease-with-dementia-and-dementia-with-lewy-bodies/