What is this study about?
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. There is no currently approved medication that targets the underlying cause and process of DLB.
This study will evaluate neflamapimod to see if it can improve learning skills, problem solving skills, and memory loss in people with DLB.
What’s involved?
By participating in this study, you can contribute to research and development of an investigational drug candidate.
Participants will complete a screening visit to find out if they qualify for the study. Participants who pass screening and choose to enroll in the study 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.
Who can participate?
An individual may be able to take part in the study if he/she meets the following qualifications:
- Men or women who are 55 years or older
- People who:
- have probable dementia with Lewy bodies (DLB)
- have a reliable caregiver who can come to study center visits and help with study procedures and evaluations
This is not a complete list of study requirements. The staff at the study center can explain the complete list of requirements.
Study Sites:
| State | City | Study Site Name | Study Contact | Email and Phone Number |
| Arizona | Tucson | Banner Alzheimer’s Institute | Jaynie Anguiano | jaynie.anguiano@bannerhealth.com (520) 694-4154 |
| Arizona | Phoenix | Barrow Neurological Institute | Jalisa Santiago | jalisa.santiago@commonspirit.org (602) 406-7851 |
| California | Pasadena | SC3 Research Group, Inc. | Wayne Pickerell | wayne.pickerell@neurosearch-usa.com (626) 250-2070 |
| Colorado | Aurora | University of Colorado Anchutz Medical Campus | Nicole Gendelman | nicole.gendelman@cuanschutz.edu (303) 724-4172 |
| Florida | Lake Worth | JEM Research Institute | Angela Rivera | arivera@jemri.net (561) 968-2933 |
| Florida | Pensacola | Panhandle Research and Medical Clinic, LLC | Lynn Jolliff | lynnhj@panhandleresearch.com (850) 619-2926 |
| Kansas | Kansas City | University of Kansas Medical Center (KUMC) | Kim Lee | klee9@kumc.edu (913) 588-0013 |
| Louisiana | Marrero | Tandem Clinical Research | Kristin Tassin | ktassin@tandemclinicalresearch.com (504) 934-8424 |
| Massachusetts | Charlestown | Massachusetts General Hospital | Hannah Webster | hawebster@mgh.harvard.edu (617) 643-5219 |
| North Carolina | Chapel Hill | University of North Carolina (UNC) | John Cherian | cherianj@neurology.unc.edu (919) 966-1350 |
| Ohio | Columbus | The Ohio State University (OSU) | Seanna Johnson | seanna.johnson@osumc.edu (614) 293-9023 |
| Virginia | Richmond | Virginia Commonwealth University (VCU) | Kara MaHaney | kara.mchaney@vcuhealth.org (804) 828-4788 |
Contact Person:
agardner@eippharma.com
Study Sponsor:
EIP Pharma
This study was funded by the National Institute on Aging (NIA)