The ATLANTIS Study: Seeking Better Dopamine Utilization

Every prescription drug used to treat Parkinson’s (or any other condition) in the US has been tested in clinical trials prior to gaining approval by the Food and Drug Administration (FDA). Other countries have similar drug testing protocols to ensure safety. 

This fall, a cohort of people with Parkinson’s can play an invaluable role in this process. UCB, a global biopharmaceutical company focused on neurological and immunological conditions, is currently enrolling participants in the phase II ATLANTIS Study.  This clinical trial is testing whether a new oral medication—currently called UCB0022—could become a treatment for Parkinson’s.  

The study will include 189 people who were diagnosed with Parkinson’s at least five years ago and who experience significant motor fluctuations, with at least two cumulative OFF hours each day.  

UCB developed the study with direct input from people with Parkinson’s and their care partners, who offered guidance through advisory panels, document reviews, and surveys. The collaboration was intended to better tailor the study to meet the needs and expectations of people with Parkinson’s and their care partners who choose to participate in the research. 

REASONS TO PARTICIPATE IN RESEARCH 

One reason to participate in clinical trials is that doing so will help people who are diagnosed with Parkinson’s in the future have access to more effective treatments. Without clinical trial participants, clinical research and drug development would be much slower. More importantly, the conclusions reached would be less reliable.  

This is far from the only reason we’ve heard people with Parkinson’s say they choose to participate in research. Some say they like to be on the cutting edge and to get to talk with researchers who are enhancing understanding of Parkinson’s. Others say they participate because doing so gives them a sense of purpose and helps them work against apathy, and still others say it’s a way to meet new people and expand their Parkinson’s community. 

“I found my first clinical trial within 24 hours of my diagnosis. Because I had been working in the biotech industry I knew the importance of participating in trials: without our participation, drug development does not happen. That first clinical trial experience was so positive that I’ve since found two more I have chosen to be a part of.” – Sarah, Davis Phinney Foundation Ambassador

There are probably as many reasons to participate in research as there are people who choose to participate. It’s important, though, that you start any participation in clinical research understanding the details of what you’re getting involved with. Participation in clinical research is important, but it is a team effort. As a participant, one role you’ll play on the team is to ensure you understand what your participation will involve. This includes understanding the risks, the requirements, and what benefits you might experience. 

This blog post presents an overview of the ATLANTIS Study, but this post can’t address every person’s individual circumstance, so consider discussing participation in research with your family and care team. If you choose to pursue participation in this study—or any study—be sure to ask all the questions you have about the study during your screening visit(s) and the informed consent process, which are described below. 

THE ATLANTIS STUDY: OVERVIEW 

The ATLANTIS Study aims to find out if the study drug, UCB0022, impacts motor fluctuations. The study will also assess the safety, tolerability (the type and amount of side effects), and pharmacokinetics (how the medication is processed in the body) of the study drug. 

A primary goal of the phase II ATLANTIS Study is to determine whether the study drug is effective enough and well-tolerated enough to be further developed. To do this, the study will compare two different doses of the study drug to a placebo (a medication that looks like the investigational drug, but contains no medicinally active ingredients).  

If you participate in the study, you will be randomly allocated to a group that receives a placebo or to a group that receives one of the doses of the study drug for the duration of the study. The study is blinded, which means that neither you nor the study team will know what group you are in. During the study, the study drug and the placebo will be provided as tablets that are taken by mouth once every morning for 10 weeks. The study drug will be given alongside whatever other standard Parkinson’s medications you may take. 

UCB is currently recruiting participants at approximately 70 locations throughout the United States. Recruitment is expected to be complete at the very end of 2024, and the study will be complete by mid-2025. 

UCB will publish a summary of the study results in a report that will be available on the UCB company website. The study results will also become available on the ATLANTIS study’s page on clinicaltrials.gov. 

WHY RESEARCHERS THINK UCB0022 MIGHT HELP 

One of the primary impacts of Parkinson’s is that it disrupts the way your body processes dopamine, a neurotransmitter that influences how your movements start and stop. Because of this, many Parkinson’s treatments work by increasing the amount of dopamine in the body. For example, carbidopa/levodopa, the most commonly prescribed Parkinson’s medication, helps with Parkinson’s symptoms because an enzyme in your body converts levodopa to dopamine.  

In the early stages of Parkinson’s, you may have sufficient production and storage of dopamine in your brain’s striatal neurons to keep Parkinson’s symptoms at a minimum with few doses of levodopa or other similar treatments. However, as time passes, the impacts of Parkinson’s on the dopamine system become more significant, and current dopamine-focused treatments become less effective. Doses must be increased in order for symptoms to be managed, and the medications can start causing troublesome side effects, such as dyskinesia and more ON/OFF fluctuations. 

The ATLANTIS Study is exploring whether UCB0022 can treat bothersome symptoms of Parkinson’s in a way that current medications can’t, with a once daily dose, taken by mouth. Researchers believe UCB0022 works by attaching itself to specific cells in the brain that are sensitive to dopamine. By doing so, the study drug may make these brain cells better able to bind to dopamine. If it works, dopamine could provide more ON-time and potentially help reduce treatment-related dyskinesia and fluctuations. 

DETAILS ABOUT PARTICIPATION IN THE ATLANTIS STUDY  

If you are interested in participating in the study, your first step will be to go through a screening phase. During this phase, a few tests will be performed to evaluate whether there is any reason you are ineligible for the study. Details about inclusion and exclusion criteria for the study appear below. 

During the screening phase, there is also an “informed consent” process. During this process, you will learn more about the purpose of the research; its potential benefits and risks; and other important details, including those about how your individual data will be stored and used. An informed consent document must be read, understood, and signed before your participation in the study can begin.   

After the screening process, if the study team determines you are eligible for the study, you will then progress to the “treatment period,” which will last for 10 weeks. This is when you’ll be randomly assigned to one of three possible study treatment groups. One group will receive a lower dose of the study drug, one group will receive a higher dose of the study drug, and one group will receive a placebo.  

During the treatment period of the study, participants will undergo various tests and procedures, including but not limited to: 

• Discussing medical history 
• Discussing current medications
• Having physical and neurological examinations 
• Having vital signs taken (blood pressure, pulse, breathing rate, and body temperature) 
• Providing blood and urine samples for laboratory testing 
• Having an ECG to check their heart activity 
• Completing questionnaires 
• Recording Parkinson’s symptoms in a paper document (aka, a study diary) 
• Participants who are between 46 and 83 years old will be asked to wear a wrist-worn device (very similar to a normal smartwatch) that automatically records movement and motor symptoms, even while participants are sleeping. 

Participants and care partners may receive travel support to and from study visits, as well as reimbursement for reasonable study-related expenses. In some cases, a stipend may also be paid. 

SPECIFIC CRITERIA FOR PARTICIPATION 

There are several criteria you need to meet to be eligible to join the ATLANTIS Study. 

People may be able to participate if they: 

• Are between 35 and 85 years of age 
• Have been diagnosed with Parkinson’s for five or more years 
• Experience daily motor fluctuations with at least two cumulative hours of OFF time every day 
• Have symptoms that respond to levodopa and are currently receiving treatment with oral daily doses of levodopa combination (levodopa/carbidopa or levodopa/benserazide) with or without oral adjunctive antiparkinsonian therapies 
• Are willing to complete a three-day symptom diary four times during the study 

People are not able to participate if they:  

• Have a history of brain surgery for Parkinson’s (including deep brain stimulation or thalamotomy) 
• Use device-aided administration of antiparkinsonian medication (medication that is infused or injected) 
• Have a diagnosis of dementia, another form of significant cognitive dysfunction, epilepsy, or another seizure disorder
• Have a history or current diagnosis of type 1 diabetes or uncontrolled type 2 diabetes 
• Have current untreated hypertension (high blood pressure) 
• Have had clinically significant arrythmia (irregular heartbeat), heart attack, stroke, transient ischemic attack (mini stroke), and/or moderate or severe congestive heart failure within the past year 
• Have had major depression or psychotic disorder or any other psychiatric condition within the past five years 
• Have a history of alcohol or drug use disorder 
• Have a positive drug/alcohol test, HIV test, or hepatitis B test at screening 

There are additional criteria that need to be met to participate in the ATLANTIS Study, which the study team at the study center will discuss with potential participants.  

Some study centers can accommodate Spanish-speaking participants. At these study locations, the Informed Consent Form and other study materials are available in Spanish and the study staff speak Spanish. 

LEARN MORE  

If you are interested in participating in the ATLANTIS study, visit the study’s website, which has more information and an interactive map that shows the study centers that are available to you. The site also features a pre-screening questionnaire you can complete to see if you may be eligible to participate. If you do, the site also has contact details to help you learn more about how to get involved. You can also watch a video overview of the ATLANTIS Study on YouTube.

If you’d like to reach out to UCB directly, you can send an email to UCBCares@ucb.com or call +1-844-599-2273. You can also visit ucb.com/UCBCares. 

ADDITIONAL RESOURCES 

A Primer about Clinical Trials for Parkinson’s  

A Conversation with Mark Stacy, MD, and Peter Schmidt, PhD, about Clinical Trials 

ATLANTIS Study Info on The Fox Trial Finder Website 

ATLANTIS Study’s Spanish Language Website 

 This post was written by the Davis Phinney Foundation. 

This post is sponsored by UCB.