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A monocentric, randomized, double-blind, placebo-controlled trial in patients with mild to moderate Alzheimer disease about efficacy and safety of the dopaminergic agonist rotigotine as an add-on to treatment with acetylcholinesterase inhibitors was published by Koch et al. Patients were randomly assigned in a 1:1 ratio to receive transdermal patch of rotigotine in a dose of 2 mg per day during one week of escalation period and 4 mg per day during 23 weeks maintenance period or matching placebo. End points were the change at 24 weeks from baseline on the Alzheimer Disease Assessment Scale–Cognitive Subscale (ADAS-Cog-11), Activities of Daily Living (ADCS-ADL), the Frontal Assessment Battery (FAB) and Neuropsychiatric Inventory (NPI). Cortical excitability and oscillatory activity over the left dorsolateral prefrontal cortex (DLPFC) and the left posterior parietal cortex (PPC) was evaluated using transcranial magnetic stimulation with electroencephalography (TMS-EEG). Rotigotine had no effects on ADAS-Cog-11. Improvement in frontal lobe functions, measured with FAB, was seen in rotigotine group (mean change 0.48) when compare to placebo group (mean change -0.66). Less decline was seen on the ADCS-ADL in the rotigotine group (mean change -3.32) when compared to placebo grou0p (mean change -7.24). No significant difference was seen for NPI. An increase of prefrontal cortex activity was found in rotigotine group. Authors conclude that treatment with rotigotine is safe in patients with mild to moderate Alzheimer disease and may have a potential effect in reducing symptoms associated with frontal lobe cognitive dysfunction and in delaying the impairment of activities of daily living.
Key Points: Alzheimer Disease; Rotigotine patch; Cognitive function; Activity of Daily Living; Neuropsychiatric Inventory
Giacomo Koch, MD, PhD; Caterina Motta, MD; Sonia Bonnì, PhD; Maria Concetta Pellicciari, PhD; Silvia Picazio, Psy, PhD; Elias Paolo Casula, PhD; Michele Maiella, MSc; Francesco Di Lorenzo, MD; Viviana Ponzo, BSc; Clarissa Ferrari, PhD; Eugenia Scaricamazza, MD; Carlo Caltagirone, MD; Alessandro Martorana, MD. Effect of Rotigotine vs Placebo on Cognitive Functions Among Patients With Mild to Moderate Alzheimer Disease A Randomized Clinical Trial. JAMA Network Open. 2020;3(7):e2010372. doi:10.1001/jamanetworkopen.2020.10372.