Become a part of the RewinD-LB Dementia with Lewy Bodies Research Study
Discover support for Dementia through your involvement in the RewinD-LD study. The study is evaluating an investigational medication specifically designed to enhance cognitive abilities, problem-solving skills, and the progression of memory loss in individuals with Lewy Body Dementia.
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Find out if you qualify for this clinical study.
Please answer the questions below to see if you may be eligible for the RewinD-LB Study.
Completing this questionnaire does not obligate you to participate in the study. Your answers will help determine if you may be eligible. If your answers indicate you may be eligible, you will have the opportunity to contact a clinic site near you to learn more about the study.
We value your privacy and assure you that your contact information will not be shared with third parties; your data is processed in accordance with our privacy policy.
About Dementia with Lewy bodies
Dementia with Lewy bodies (DLB) is a disease associated with abnormal deposits of protein in the brain. These deposits are called Lewy bodies. Lewy bodies affect chemicals in the brain that can lead to problems with thinking, movement, behavior, and mood.
DLB is characterized by progressive dementia, and fluctuating problems with memory and attention. Sleep disturbances, hallucinations, as well as tremors and problems with movement (called Parkinsonism) are also common symptoms. Managing this disease can be difficult and disruptive for both people with DLB and their caregivers.
Why Is This Study Important?
There is an urgent need for safe and effective treatments that can help people with Lewy Body Dementia.
There is no currently approved medication that targets the underlying cause and process of DLB. Only symptomatic treatments are available for Parkinsonian symptoms. This is why medical researchers look for new and, hopefully, better treatments for individuals with DLB. Before new medications can be approved for public use, they must be tested in research studies like this one. If you or a loved one has probable DLB, please consider participating in this study.
If you decide to join the RewinD-LB study, your health and safety will carefully be monitored by specialists, and your participation will help doctors evaluate the study drugs to measure it's effectivity.
Why you should participate:
Access to the study drug for 16 weeks that may slow or prevent your Dementia progression.
Close care and monitoring from an DLB specialist.
The opportunity to help advance the treatment of Dementia with Lewy Body.
Reimbursement for both patient and caregiver for study-related time and travel expenses.
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.
The Role of Synaptic Dysfunction in Dementia with Lewy Bodies
The brain's billions of neurons connect through synaptic connections, which can be affected by excessive inflammation and the toxicity of alpha synuclein. In DLB, this occurs in the basal forebrain and impacts cholinergic neurons, leading to cognitive and motor impairments. However, synaptic dysfunction in the basal forebrain is reversible in animal models, suggesting that therapeutics targeting this dysfunction, such as neflamapimod, have the potential to reverse these impairments*.
About Neflamapimod
Neflamapimod is an investigational drug that is an orally administered small molecule brain penetrant that inhibits p38MAP kinase alpha (p38a). p38a plays a major role in inflammation-induced synaptic toxicity. Neflamapimod is currently being developed for the treatment of dementia with Lewy bodies (DLB) and is the first treatment with the potential to have a positive impact on cognition, function and motor function in DLB*.
Who can participate?
You may be eligible to join if you are:
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Have probable dementia with Lewy bodies (DLB)
Symptoms
Be 55 years or above
Age
All
Gender
Required
Study Partner
This is not a complete list of study requirements. The staff at the study center will explain the complete list of requirements
Please note that this study may require a study partner. If this has stopped you from participating in the past, please get in touch to discuss your eligibility for this new study.
If you are interested in participating in this research study, or think a loved one may be interested, please provide your contact information on the form.
More information about the study
The RewinD-LB study is evaluating an investigational medication for people with DLB. Here are some commonly asked questions for you to learn more about this opportunity.
What is the RewinD-LB study?
RewinD-LB is a randomized, double-blind, placebo-controlled phase 2b clinical trial of neflamapimod in patients living with DLB.
What is the 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.
Study Extension. What is it?
Extension
All study participants who complete the main study will be offered an opportunity to continue in an extension study. In the extension study, all participants will receive neflamapimod for an additional 32 weeks (8 months), regardless of whether they received neflamapimod or placebo during the main study. The extension study will involve an additional 5 study center visits.
What are the costs and expenses?
There is no cost to participate. Participants do not pay for the study drug, clinic 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.
What are the 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.
What are the next steps?
If you are interested to learn more about this study, please contact us using the form on this page. If you contact us, you will not be obligated to participate in this study. Participation is entirely voluntary.
You may also reach out to:
SC3 Research Group, Inc.
Principal Investigator: Artin Minaeian, M.D
50 Bellefontaine St., Ste 203, Pasadena, CA 9110
Contact information: Roxanne Cabading
Main: 6262502070 x 799
Email: roxanne.cabading@neurosearch-usa.com
Find out if you qualify for this clinical study.
Please answer the questions below to see if you may be eligible for the RewinD-LB Study.
Completing this questionnaire does not obligate you to participate in the study. Your answers will help determine if you may be eligible. If your answers indicate you may be eligible, you will have the opportunity to contact a clinic site near you to learn more about the study.
For more information about the study
Please visit these public sources:
RewinD-LB: : A Phase 2b Clinical Study - Lewy Body Dementia Association
Dementia with Lewy Bodies - CERVOMED
Clinical Study of Neflamapimod in Patients With Dementia With Lewy Bodies - clinicaltrials.gov
If you have problems accessing the website or have questions regarding the study please contact the research team via email (roxanne.cabading@neurosearch-usa.com) or phone (16262502070 ext 799)
