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 | Amber Durr Venable | Avenable@tandemclinicalresearch.com (504)-934-8079 |
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 | Arlington | Sana Research | Deborah Guardado | dguardado@sanaresearch.com (703) 717-7755 |
Virginia | Fairfax | Re:Cognition Health – Fairfax | Zak Al-Sarraf | zalsarraf@re-cognitionhealth.com (571) 418-0142 |
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 |
England, UK | Cambridgeshire |
Windsor Research Unit Cambridgeshire and Peterborough NHS Foundation Trust
|
Naomi Thomas | naomi.thomas@cpft.nhs.uk |
England, UK | Hamshire | Memory Assessment and Research Center (MARC) Southern Health NHS Foundation Trust | Rebecca Beardmore | rebecca.beardmore@southernhealth.nhs.uk |
England, UK | London | Re: Cognition Health | Mattia Orru | morru@re-cognitionhealth.com |
England, UK | London | South London and Maudsley Hospital NHS Foundation Trust | Miranda Longworth-Krafft | mlongworth-krafft@slam.nhs.uk |
England, UK | London |
NIHR UCLH Clinical Research Facility University College London Hospitals NHS Foundation Trust
|
Prof Rimona Weil | r.weil@ucl.ac.uk |
England, UK | Newcastle | Newcastle CARU (Clinical Ageing Research Unit) CNTW NHS Foundation Trust | Helen Pilkington | helen.pilkington@ncl.ac.uk |
England, UK | Redruth |
University of Exeter Cornwall Partnership NHS FOUndation Trust
|
Charlotte Moorehouse | charlotte.moorehouse@nhs.net |
Ireland, UK | Belfast |
Queens University Belfast Belfast Health & Social Care Trust
|
Eileen Fox | eileen.fox@belfasttrust.hscni.net |
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)