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The RewinD-LB study
The RewinD-LB study is evaluating an investigational medication for people with Dementia with Lewy bodies (DLB).
- May contribute to new DLB treatments.
- Aid in testing potential DLB treatment.
About the RewinD-LB study
In this research study we will evaluate neflamapimod to see if it can improve learning skills, problem solving skills, and memory loss in people with DLB. Neflamapimod is investigational because it has not yet been approved by medical authorities.
Eligibility Requirements
To join this study, potential study participants must:
This is not a complete list of study requirements. The staff at the study center will explain the complete list of requirements.
- be 55 years of age or above
- have probable dementia with Lewy bodies (DLB)
- must have a reliable caregiver who can come to study center visits and help with study procedures and evaluations
Risks and Benefits
All drugs and medical procedures carry a risk of side effects. Therefore, it is possible that participants may experience some discomfort or other reactions from the use of neflamapimod or from the study procedures or tests. The study staff will explain these risks before potential participants decide whether to participate in the study. The safety of participants will be closely monitored throughout the study.
The information learned from this study may help find new treatment options in the future for people who have dementia with Lewy bodies. Participants will help contribute to the testing of this potential new treatment for DLB. There is no guarantee that study participants will receive any direct benefit from their assigned study treatment.
Cost and Expenses
There is no cost to participate. Participants do not pay for the study drug, Center visits, or study-related medical procedures or tests. Participants who satisfy applicable requirements may be compensated for study-related time and expenses. Please ask the study staff for details.
Treatment Period
Participants will complete a Screening Visit to find out if they qualify for the study. Participants who pass screening will be assigned to take a neflamapimod capsule or a placebo capsule. Both capsules will look the same, but the placebo has no active ingredients. The assignment is made randomly like flipping a coin. The assigned treatment will be taken 3 times a day for 16 weeks (4 months). During the treatment period, participants will visit the study center for tests and exams 6 times and one additional time after the treatment period ends.
All study participants who complete the initial 16-week period of the study will be able to continue in the study and receive neflamapimod for an additional 32 weeks (8 months), regardless of whether they received neflamapimod or placebo during the first 16 weeks. The extension study will involve an additional 5 study center visits.
Next Steps
If you are interested to learn more about this study, please contact us using the information on the back of this brochure. If you contact us, you will not be obligated to participate in this study. Participation is entirely voluntary.
