RewinD-LB: A Phase 2b Clinical Study of the P38 Alpha Kinase Inhibitor Neflamapimod in Patients with Dementia with Lewy Bodies (DLB)

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.

United States Study Sites:

State City Study Site Name Study Contact Email and Phone Number
Arizona Phoenix Barrow Neurological Institute Jalisa Santiago jalisa.santiago@commonspirit.org
(602) 406-7851
Arizona Sun City Banner Sun Health Research Institute Michele Gutierrez michele.gutierrez@bannerhealth.com
(623) 832-5706
Arizona Tucson Banner Alzheimer’s Institute Jaynie Anguiano jaynie.anguiano@bannerhealth.com
(520) 694-4154
California La Jolla University of California San Diego (UCSD) Jasmin Hernandez jah022@health.ucsd.edu
(858) 246-2533
California Newport Beach Hoag Memorial Hospital Presbyterian Madison Martin madison.martin@hoag.org
(949) 764-8190
California Palto Alto Stanford Neuroscience Health Center Kaila Sevilla kailas44@stanford.edu
(650) 454-5458
California Pasadena SC3 Research Group, Inc. Wayne Pickerell wayne.pickerell@neurosearch-usa.com
(626) 250-2070
Colorado Aurora University of Colorado Anchutz Medical Campus Lauren McCall lauren.mccall@cuanschutz.edu
(303) 724-3624
Florida Lake Worth JEM Research Institute Angela Rivera arivera@jemri.net
(561) 968-2933
Florida Miami University of Miami Shanell Disla sxd1210@med.miami.edu
(561) 869-6825
Florida Orlando Advent Health Estephanie Charria estephanie.charria@adventhealth.com
(407) 303-1590
Florida Pensacola Panhandle Research and Medical Clinic, LLC Lynn Jolliff lynnhj@panhandleresearch.com
(850) 619-2926
Florida Viera ClinCloud Matthew Arcemont marcemont@myclincloud.com
(407) 680-0534
Illinois Chicago Rush University Medical Center Katheryn Woo katheryn_woo@rush.edu
(312) 563-6602
Kansas Kansas City University of Kansas Medical Center (KUMC) Kim Lee klee9@kumc.edu
(913) 588-0013
Louisiana Marrero Tandem Clinical Research Nikki La Croix NLaCroix@tandemclinicalresearch.com
(504) 934-8424
Maryland Baltimore Johns Hopkins University (JHU) Nicki Marcantoni nbair2@jhmi.edu
(410) 955-8909
Massachusetts Charlestown Massachusetts General Hospital Hannah Webster hawebster@mgh.harvard.edu
(617) 643-5219
Minnesota Rochester Mayo Clinic Marissa Manthei manthei.marissa@mayo.edu
(507) 293-0906
Nebraska Omaha University of Nebraska Medical Center (UNMC) Nick Miller nicholas.miller@unmc.edu
(402) 552-5241
Nevada Las Vegas Cleveland Clinic – Lou Ruvo Center for Brain Health Laurinda Keelen keelenl@ccf.org
(702) 701-7941
New York New York Columbia University (CU) Katrina Cuasay kc2305@cumc.columbia.edu
(212) 305-2077
North Carolina Chapel Hill University of North Carolina (UNC) John Cherian cherianj@neurology.unc.edu
(919) 966-1350
Ohio Canton NeuroScience Research Center Odessa Martin odessam@neurocarecenter.com
(330) 244-2542
Ohio Cleveland Cleveland Clinic Janel Thomas thomasj3@ccf.org
(216) 444-0675
Ohio Columbus The Ohio State University (OSU) Seanna Johnson seanna.johnson@osumc.edu
(614) 293-9023
Oregon Portland Center for Cognitive Health Ericka Eyton ericka@centerforcognitivehealth.com
(503) 207-2066
Texas Houston Houston Methodist Hospital Maushami Gurung mgurung@houstonmethodist.org
(346) 238-1565
Virginia Richmond Virginia Commonwealth University (VCU) Kara MaHaney kara.mchaney@vcuhealth.org
(804) 828-4788
Washington DC Georgetown Luke Lovelace ll928@georgetown.edu
(757) 802-5001

 

Europe Study Sites:

Country City Study Site Name Study Contact Email and Phone Number
Netherlands Amsterdam Brain Research Center (BRC) – Amsterdam info@brainresearchcenter.nl
Netherlands Den Bosch Brain Research Center (BRC) – Den Bosch info@brainresearchcenter.nl
Netherlands Zwolle Brain Research Center (BRC) – Zwolle info@brainresearchcenter.nl

 

Study Sponsor:

EIP Pharma

This study was funded by the National Institute on Aging (NIA)