FAQ

The purpose of this study is to determine if a drug called adalimumab can reduce or prevent emergence or progression of synuclein-related neurodegeneration, or nerve cell death, in people with RBD. Your voluntary participation in this study would help researchers understand the progression of RBD into neurodegenerative disorders such as Parkinson’s disease or Lewy Body Dementia, and the effect of adalimumab injections, if any, on that process, compared to placebo.

The entire length of the study will be 2 years.

• You will need to come to the study site about 9 times over the course of 2 years. During these study visits, you will answer questions about your health, undergo study assessments, undergo imaging, and provide biological samples for testing.
• You may be asked to undergo a Lumbar Puncture to collect cerebrospinal fluid, if you are eligible.

• You are within the age range of 50-80 years old. You can provide written informed consent and are able and willing to comply with study-specific procedures.
• For a full list of eligibility requirements, please visit https://clinicaltrials.gov/study/NCT06996652

There will be no charge to you for your participation in this study. The study drug, study-related procedures, and study visits will be provided at no charge to you or your insurance company.

• Yes, you will be paid for taking part in this study. You will receive $200 for each complete study visit. There is also a stipend to cover meals, and mileage.
• Your study party will also be paid $75 for each complete visit.

Since the use of the study drug adalimumab in people with RBD is investigational, there may be other risks that are unknown. Additionally, there may be unknown risks to a pregnancy, embryo, or fetus if you or your female partner becomes pregnant.

You may or may not benefit because of your participation in this study. Any benefit you experience may reflect the prevention, delaying or slowing the emergence of new neurological and cognitive symptoms, but be aware that this may not be apparent to you. There is, however, no guarantee that you will benefit from your participation in this study. Information learned from the study may help other people in the future.

This study is collecting data and biospecimens from you. We would like to make your data and biospecimens available for other research studies that may be done in the future. The research may be about similar diseases or conditions to this study.

Your decision to participate in this study is voluntary. You may choose to not participate, or you may withdraw from the study for any reason without penalty or loss of benefits to which you are otherwise entitled and without any effect on your future medical care. However, please note that the FDA requires that any information collected up to the point of your withdrawal cannot be removed from the study.

Please visit the ClinicalTrials.gov website. There you will see the most up-to-date information on the study, eligibility requirements, and recruiting sites.