A 24-Week Phase 3 Study Testing Rotigotine and Rivastigmine Treatment in Adults Aged 50 to 85 with Mild to Moderate Alzheimers Disease

What this Trial Is About

Researchers are evaluating the safety and effectiveness of rotigotine combined with rivastigmine in people with mild to moderate Alzheimers disease. This phase III, 24-week study compares this combination to rivastigmine with a placebo patch. The study design is randomized and double-blind to reduce bias and improve reliability of results. Participants will receive either a rotigotine 4 mg24 hours transdermal patch or a placebo patch, alongside rivastigmine, for 24 weeks. The study includes baseline assessments followed by treatment visits at Weeks 6, 12, and 24. EEG exams and plasma biomarker collections happen at the start and end of the study. Caregivers will also be contacted by phone between visits and additional visits may occur if safety concerns arise. During the study, participants will have physical and neurological exams, vital signs measured, and adverse events recorded at screening and each visit. Cognitive and behavioral assessments will measure changes in frontal lobe function, daily living activities, cognition, memory, and apathy. The total participation time is 24 weeks, with close monitoring to ensure safety and collect comprehensive data on treatment effects.

A Phase 3 Study of Rotigotine in Combination with Rivastigmine in Mild to Moderate Alzheimer's Disease