RecruitingPhase 3NCT06702124

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

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.


Sponsor

I.R.C.C.S. Fondazione Santa Lucia

Enrollment

348 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is testing whether adding the drug rotigotine (a dopamine-boosting patch also used for Parkinson's disease) to an existing Alzheimer's medication called rivastigmine can improve thinking and memory in people with mild-to-moderate Alzheimer's disease. **You may be eligible if...** - You are between 50 and 85 years old - You have been diagnosed with Alzheimer's disease - You have been taking the rivastigmine skin patch at the correct dose for at least 3 months - Your memory and thinking scores fall in the mild-to-moderate range (MMSE score between 18 and 26) - A caregiver who lives with you or sees you regularly is available to help with the study - You have brain imaging or fluid test results supporting the Alzheimer's diagnosis **You may NOT be eligible if...** - You have severe Alzheimer's disease or another type of dementia - You have significant depression - You have less than 5 years of formal education - Your general health is not adequate for participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRotigotine 4Mg/24Hrs Patch

Rotigotine 4 mg/24Hrs administration for 24 weeks

DRUGPlacebo

Placebo administration for 24 weeks


Locations(1)

Santa Lucia Foundation

Rome, Italy, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06702124


Related Trials