LBDA

AscenD-LB Study - clinical study evaluating improvement in cognitive function in DLB patients

What is this study about? 

The purpose of this study (AscenD-LB) is to understand if neflamapimod has an effect on cognitive function (attention, memory) in those with dementia with Lewy bodies (DLB).

What is involved? 

Participants of this study will be randomly assigned to either an oral dose of neflamapimod or an inactive substitute (placebo) for 16 weeks. Neither the study participant nor the researcher will know who is receiving neflamapimod, which is called a double-blind study. Study participants may require MRI, CT, DaTscan, cognitive tests, electrocardiodiagram, physical examination, and biomarker testing. 

ClinicalTrials.gov information available in the link here.
 

What is Neflamapimod

Neflamapimod is an oral, selective small molecule inhibitor of the protein kinase p38 alpha. Extensive research has shown that p38 alpha is a key driver of synaptic dysfunction, which leads to neurodegeneration.

Who can participate? 

An individual may be able to join the study if he/she meets the following criteria:

  • Man or woman 55 years of age or older
  • Individual or individual's legally authorized representative willing and able to provide informed consent
  • Person with probable DLB
  • Currently receiving cholinesterase inhibitor therapy
  • Normal or corrected eyesight and auditory ability
  • No history of learning difficulties
  • Have reliable informant or caregiver

Study Locations:

The AscenD-LB study will be conducted at the following locations:

Site Location Site Contact Email
University of Kansas Medical Center Kansas City, KS Kelly Lyons klyons@kumc.edu
University of Rochester Rochester, NY Nicole Guerrero nicole_guerrero@URMC.Rochester.edu
University of Washington Seattle, WA Yeung Tutterrow ylt2@uw.edu
Cleveland Clinic - Las Vegas Las Vegas, NV Dr. Aaron Ritter rittera@ccf.org
Northwest Clinical Research Center Bellevue, WA Leslie Gillis lgills@nwcrc.net
Ohio State University Columbus, OH Brooke Eiginger brooke.eiginger@osumc.edu
Summit Research Network Portland, OR Annika Truitt atruitt@summitnetwork.com
Massachusetts General Hospital Charlestown, MA Anna Bolling abolling1@mgh.harvard.edu
Oregon Health and Science University (OHSU) Portland, OR Kellie Keith keithk@ohsu.edu
John Wayne Cancer Institute
(Pacific Neuroscience Institute)
Santa Monica, CA Mini Gill jaya.gill@providence.org
National Clinical Research, Inc.
Alzheimer's Research Center
Richmond, VA Kelly Gilpatrick kgilpatrick@ncrinc.net
Columbia University New York, NY Ruth Tejeda rbt41@cumc.columbia.edu
Y&L Advance Health Care dba Elite Clinical Research Miami, FL Nuvia Herrera nuvia.elite@live.com
University of Virginia Charlottesville, VA Colleen Webber cmn6x@virginia.edu
University of Michigan Ann Arbor, MI Catherine Dowling cdowling@med.umich.edu
Jefferson University Hospitals Philadelphia, PA Aaron Roberts aaron.roberts@jefferson.edu
Mayo Clinic Rochester, MN Kevin Nelson nelson.kevin1@mayo.edu
University of North Carolina Chapel Hill, NC Carlos Velez carlosv@email.unc.edu
Cleveland Clinic Cleveland, OH Christine Whitman whitmac@ccf.org
University of California San Diego, CA Rachel Schade rschade@ucsd.edu
University of Colorado Aurora, CO Abigail Simpson abigail.simpson@ucanschutz.edu
Inland Northwest Research Spokane, WA Deann Dickinson ddickinson@inwresearch.com

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Study Sponsor: 

EIP Pharma