Effects of Dopaminergic Therapy in Patients with Alzheimer's Disease: a 24 Weeks Prospective, Randomized, Double-blind, Placebo-controlled, Parallel Group, International, Multi-center Phase III Study Evaluating Efficacy and Safety of Rotigotine 4 Mg/24 Hrs in Combination with Rivastigmine 9.5 Mg/24 Hrs in Mild to Moderate Alzheimer's Disease Patients.
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 exclusion criteria, number 3)
• 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)
• Evidence of frontal lobe dysfunctions as assessed by FAB ≤14
• Absence of major depressive disease according to GDS of \< 5
⁃ Formal education for five or more years
⁃ Previous decline in cognition for more than six months as documented in patient medical records
⁃ A caregiver available and living in the same household or interacting with the patient and available if necessary to assure administration of drug
⁃ Patients living at home or nursing home setting without continuous nursing care
⁃ General health status acceptable for a participation in a 6-month clinical trial
⁃ Stable pharmacological treatment of any other chronic condition for at least one month prior to screening
⁃ No regular intake of prohibited medications
⁃ Signed informed consent by the patient. If there are any doubts that the patient is mentally capable of giving informed consent, the patient will be examined and verified to be mentally capable by an independent physician/ neurologist, prior to the initiation of any study specific procedure. Signed consent of the caregiver