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Study on the Effects of Rotigotine and Rivastigmine in Patients with Mild to Moderate Alzheimer's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for patients with Alzheimer's disease, specifically those in the mild to moderate stages. The treatment being tested involves a combination of two medications: rotigotine and rivastigmine. Rotigotine is delivered through a transdermal patch, which means it is applied to the skin and the medication is absorbed over time. Rivastigmine is also used in patch form. The study will compare the effects of using both medications together against using rivastigmine with a placebo.

The purpose of the study is to evaluate how well the combination of rotigotine and rivastigmine improves cognitive functions related to the frontal lobe of the brain, which are important for tasks like decision-making and problem-solving. Participants will be randomly assigned to different groups, and neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This is known as a double-blind study. The study will last for 24 weeks, during which participants will be monitored regularly to assess the safety and effectiveness of the treatment.

Throughout the study, participants will continue to live at home or in a nursing home setting, and they will need to have a caregiver available to help with the administration of the medication. The study aims to provide valuable information on whether the combination of rotigotine and rivastigmine can offer better outcomes for individuals with mild to moderate Alzheimer's disease compared to the current standard treatment with rivastigmine alone.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be assessed to confirm eligibility based on specific criteria related to Alzheimer's disease.

    The patient will provide informed consent to participate in the study.

  2. Step 2

    Baseline assessment

    A baseline assessment will be conducted to evaluate the patient's current cognitive functions and health status.

    This assessment will include tests and evaluations to establish a starting point for the study.

  3. Step 3

    Medication administration

    The patient will receive a Neupro 4mg/24h transdermal patch containing the active substance rotigotine.

    The patch is applied to the skin and delivers medication continuously over 24 hours.

    In addition, the patient will receive rivastigmine 9.5 mg/24 hrs as part of the treatment regimen.

  4. Step 4

    Treatment period

    The treatment will continue for a period of 24 weeks.

    During this time, the patient will apply the transdermal patch daily and take rivastigmine as prescribed.

  5. Step 5

    Regular monitoring

    Throughout the study, the patient's cognitive functions and overall health will be monitored regularly.

    This monitoring will help assess the effectiveness and safety of the treatment.

  6. Step 6

    Final assessment

    At the end of the 24-week period, a final assessment will be conducted.

    This assessment will evaluate changes in cognitive functions and any effects of the treatment.

Who can join the trial?

16 criteria

  • Men and women who cannot have children, with a diagnosis of **Alzheimer's disease**.
  • Aged between 50 and 85 years.
  • Had an **MRI** or **CT scan** within the last year that supports the Alzheimer's diagnosis and rules out other causes of memory problems, like blood vessel issues in the brain.
  • Have **CSF biomarker** data or a positive **Amyloid PET Scan** from the last three years that supports the Alzheimer's diagnosis.
  • In the mild to moderate stage of Alzheimer's, as shown by a **MMSE** score between 18 and 26. The **MMSE** is a test that checks memory and thinking skills.
  • Have a **Clinical Dementia Rating (CDR)** score of 0.5 or 1, indicating mild dementia.
  • Show signs of problems with the **frontal lobe**, which is a part of the brain, as shown by a **FAB** score of 14 or less. The **FAB** is a test that checks thinking skills related to the frontal lobe.
  • Do not have major depression, as shown by a **GDS** score of less than 5. The **GDS** is a test for depression.
  • Have completed at least eight years of formal education.
  • Have shown a decline in memory or thinking skills for more than six months, as noted in medical records.
  • Have a caregiver who lives with them or interacts with them regularly and can help with taking the study medication if needed.
  • Live at home or in a nursing home without needing constant nursing care.
  • Have a general health status that is good enough to participate in a six-month clinical trial.
  • Have been on a stable treatment for any other long-term health condition for at least one month before the study starts.
  • Do not regularly take medications that are not allowed in the study.
  • Have signed a consent form to participate in the study, and their caregiver has also signed a consent form.

Who cannot join the trial?

9 criteria

  • Patients with severe Alzheimer's disease cannot participate. This study is only for those with mild to moderate Alzheimer's disease.
  • Patients who are younger than 50 years old or older than 85 years old are not eligible. The study is for people aged 50 to 85.
  • Patients who are not able to give their own consent to participate in the study are excluded. This means they must understand and agree to join the study themselves.
  • Patients who have other serious health conditions that might interfere with the study cannot participate. This includes conditions that affect the brain or nervous system.
  • Patients who are currently participating in another clinical trial are not allowed to join this study.
  • Patients who have had a recent history of drug or alcohol abuse are excluded. This means they have not had problems with drugs or alcohol in the recent past.
  • Patients who are pregnant or breastfeeding cannot participate in the study.
  • Patients who have allergies or bad reactions to the study medications or similar drugs are not eligible.
  • Patients who have had a major surgery or a serious injury recently are excluded from the study.
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Investigated drugs

  • Rotigotine

    is a medication used in this study to help improve cognitive functions in patients with Alzheimer's disease. It is applied through a patch on the skin, which releases the medication over a 24-hour period. The study aims to see how well rotigotine works when used together with another medication, rivastigmine, in improving certain brain functions.

  • Rivastigmine

    is another medication used in this study, commonly prescribed to help manage symptoms of Alzheimer's disease. It is also delivered through a patch that releases the medication over 24 hours. In this trial, rivastigmine is used both alone and in combination with rotigotine to compare the effects on cognitive functions in patients.

What is already known about the treatment

  • Rotigotine

    Rotigotine is administered through a transdermal patch, which is applied to the skin, allowing the medication to be absorbed over a 24-hour period. It is currently being studied in clinical trials for its potential benefits in treating mild to moderate Alzheimer's disease. The main therapeutic indication for rotigotine in this context is to improve cognitive functions, particularly those related to the frontal lobe. At the molecular level, rotigotine acts as a dopamine agonist, meaning it stimulates dopamine receptors in the brain, which may help improve cognitive symptoms. It is classified pharmacologically as a dopaminergic agent.

  • Rivastigmine

    Rivastigmine is administered via a transdermal patch, which delivers the medication through the skin over a 24-hour period. It is an established treatment for mild to moderate Alzheimer's disease, and its use is well-documented in medical literature. The primary therapeutic indication for rivastigmine is to enhance cognitive function by increasing the levels of acetylcholine, a neurotransmitter important for memory and learning. It works by inhibiting the enzyme acetylcholinesterase, which breaks down acetylcholine, thereby increasing its availability in the brain. Rivastigmine is classified as a cholinesterase inhibitor.

Investigated diseases

Alzheimer's Disease – Alzheimer's disease is a progressive neurological disorder that affects memory, thinking, and behavior. It is characterized by the gradual decline in cognitive functions, including memory loss, confusion, and difficulty with language and problem-solving. In the mild to moderate stages, individuals may experience increased forgetfulness, trouble organizing thoughts, and challenges in performing daily tasks. As the disease progresses, symptoms become more pronounced, leading to greater dependency on caregivers. Changes in mood and behavior, such as depression or irritability, may also occur. The disease primarily affects older adults, but its exact cause remains unknown.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504602-11-00Protocol codeDOPAD-3Estimated enrolment378 patientsSponsorFondazione Santa Lucia

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