drugset / Trial / NCT06702124

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

NCT06702124

Phase 3 Recruiting 348 enrolled Santa Lucia Foundation IRCCS
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2023-12-01
Primary completion
2025-07
Completion
2026-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Rotigotine Unknown 4 mg Other

Indications