This is a 24-week prospective, randomized, double-blind, placebo-controlled, multi-center phase III study evaluating efficacy and safety of rotigotine 4mg/24 hrs in combination with rivastigmine 9.5 mg/24 hrs in mild to moderate AD patients. The total study duration per patient from baseline to the end will be 24 weeks. The study has a placebo-controlled design to eliminate experimental biases that arise from a participants' expectations, observer's effect on the participants, observer bias, confirmation bias, and other sources.
Men and women (non-childbearing potential, as defined in Appendix 2) with a diagnosis of AD according to IWG criteria
Age 50-85 years
MRI or computerized tomography (CT) assessment, corroborating the clinical diagnosis of AD and excluding other potential causes of dementia, especially cerebrovascular lesions (see
Patients who show CSF biomarker data supporting the diagnosis of AD (for Czech Republic only: lumbar punctures can be performed for screening purposes), or patients with a positive Amyloid Pet Scan will qualify for the study
Stable on a treatment with rivastigmine transdermal patch for at least 3 months, of which at least the last month was at 9.5mg/day, or for one month, if the patient had received donepezil before rivastigmine
Mild to moderate stage of AD according to MMSE ≥18 and ≤26
Clinical Dementia Rating (CDR) total score of 0.5 or 1 (mild)
Parallel
Rotigotine 4Mg/24Hrs Patch
DrugRotigotine 4 mg/24Hrs administration for 24 weeks
Placebo
DrugPlacebo administration for 24 weeks
Change from Baseline to Week 24 in the FAB to evaluate efficacy of rotigotine in combination with rivastigmine on frontal lobe cognitive functions as compared to rivastigmine in combination with placebo.
FAB is a brief battery of six neuropsychological tasks designed to assess frontal lobe function
Change from Baseline to Week 24 in the ADCS-ADL to evaluate efficacy of rotigotine in combination with rivastigmine on autonomies of daily living as compared to rivastigmine in combination with placebo
The ADCS-ADL includes 23 items that were derived from a larger set of items describing performance of activities of daily living
Change from Baseline to Week 24 in the MoCA to evaluate efficacy of rotigotine in combination with rivastigmine on cognition as compared to rivastigmine in combination with placebo.
The MoCA is a brief, simple, and reliable screening test for AD. The test checks language, memory, visual and spatial thinking, reasoning, and orientation skills.
Change from Baseline to Week 24 in the CDR-SOB, to evaluate efficacy of rotigotine in combination with rivastigmine on cognition as compared to rivastigmine in combination with placebo
The CDR is a 5-point scale used to characterize six domains of cognitive and functional performance applicable to AD and related dementias: Memory, Orientation, Judgment \& Problem Solving, Community Affairs, Home \& Hobbies, and Personal Care
Change from Baseline to Week 24 in the ADAS-Cog14 to evaluate efficacy of rotigotine in combination with rivastigmine on memory functions as compared to rivastigmine in combination with placebo.
ADAS-cog assesses the level of cognitive dysfunction in AD. The ADAS-Cog14 consists of items from the following areas chosen for their sensitivity to AD: language; memory; praxis executive functions and orientation.
Change from Baseline to Week 24 in the EEG recordings, to evaluate effects of rotigotine in combination with rivastigmine or rivastigmine in combination with placebo on cortical oscillatory activity.
All patients will undergo resting EEG recordings at the beginning and at the end of the experimental protocol with a 21 channels EEG. The neurophysiological measurement will be performed with the eyes closed and will last 3 minutes.
Change from Baseline to Week 24 in plasma Neurofilament light chain (NfL) and Aβ42 and p-tau concentrations to evaluate effects of rotigotine in combination with rivastigmine in combination with placebo on plasma biomarkers
Plasma samples will be collected according to the trail schedule
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