Dementia with Lewy Bodies Consortium (U01)

James Leverenz, MD
James Leverenz, MD
Cleveland Clinic


An estimated 1.4 million Americans suffer from Lewy body dementia (LBD), including both dementia with Lewy bodies (DLB) or Parkinson's disease with dementia (PDD). Patients with DLB present with cognitive changes, similar to Alzheimer's disease (AD), and can also suffer with motor and behavioral changes similar to Parkinson's disease (PD). Because of these similarities, DLB is often confused with AD or PD, making it difficult to diagnose patients accurately. A biological marker (biomarker) from blood, urine, or other biofluid for DLB may eliminate this confusion and improve treatment of LBD patients. However, the development of biomarkers for DLB has been difficult because this research requires large groups of patients to study in a consistent manner over time. This project establishes a group of centers dedicated to the study of DLB, the DLB consortium (DLBC). DLBC will enroll a large number of subjects from across the United States; perform systematic assessments (compatible with other AD and PD programs); collect biofluids, imaging data, and ultimately autopsy results; and bring together experts in DLB to perform collaborative research. The ultimate goal of DLBC is to allow for the discovery of a biomarker for DLB to improve the diagnosis, care, and treatment of patients with this disease.


It has been estimated that 1.4 million people in the United States suffer from Lewy body dementia (LBD), including both dementia with Lewy bodies (DLB) or Parkinson's disease with dementia (PDD). Patients with LBD suffer from cognitive decline, sometimes linked to Alzheimer's disease (AD), and the motor and behavioral changes seen in Parkinson's disease (PD). Unfortunately, the diagnosis of LBD can be difficult, particularly in those DLB patients that present with cognitive impairment prior to motor or marked behavioral changes. Biomarkers for LBD are few and their value in diagnosis, prognosis, and for treatment response is limited. Impediments to biomarker development in LBD have included small subject numbers, a lack of systematic patient characterization, and a failure to perform longitudinal follow up with autopsy. Both AD and PD have benefited from a number of large “consortiums” that have advanced research by leveraging the strengths of several groups of research centers to combine efforts with standardized approaches to the study of the disease. One good example is the Alzheimer's Disease Centers (ADC) program, funded by the National Institute on Aging, where over 30 research centers across the United States have agreed to a standardized approach to the diagnosis and characterization of patients with AD. Other similar programs include the Alzheimer's Disease Cooperative Study (ADCS), Alzheimer's Disease Neuroimaging Initiative (ADNI), the National Institute of Neurological Disorders and Stroke (NINDS) Parkinson's Disease Biomarker Program (PDBP), and the Parkinson's Progression Marker Initiative (PPMI). Fortunately, the latter two PD programs have included more systematic clinical assessments and collection of biofluids and imaging data relevant to cognition in PD. Recently, a pathology component has been added to the PPMI project. No similar program exists for DLB. The objective of this proposal is to establish a consortium of centers for the study of DLB with a large number of subject enrolled, systematic assessments (compatible with AD and PD programs), collection of biofluids and imaging data, and ultimately autopsy. The DLB consortium (DLBC) would create the necessary foundation for biomarker development and have the secondary benefit of creating an ongoing subject sample available for additional translational and therapeutic studies. We have brought together nine centers with expertise in the Lewy body disorders and with strong connections to the Lewy body dementia research and general community to participate in the DLBC. This group of investigators has collaborated extensively together for many years and will provide the foundation for this much needed resource. PUBLIC HEALTH RELEVANCE: The Lewy body dementias are the second most common cause of dementia in the elderly. Research into this common form of dementia has been hindered by the need for large groups of patients to study in a consistent manner over time. The Dementia with Lewy Body Consortium will address this issue by bringing together a group of experts that will study a large number of patients from across the country over a two to five year period.


Goals of Project

  • Resource Building: To establish the Dementia with Lewy Bodies Consortium (DLBC) with Thomas Jefferson University, Florida Atlantic University, Rush University, University of Pennsylvania, University of Pittsburgh, VA/Puget/University of Washington, University of California San Diego, University of North Carolina and headed by Cleveland Clinic.
  • Resource Building: To establish a DLBC coordinating center to provide oversight of the DLB consortium activities, coordinate annual meetings, etc.
  • Recruitment: To develop a large registry (216 subjects) of individuals with probable Dementia with Lewy Bodies (DLB) or high likelihood DLB subtype of mild cognitive impairment (MCI) by bringing together multiple clinical investigation sites with expertise in Lewy Body Dementia (LBD).
  • Assessment: To systematically and longitudinally evaluate these Dementia with Lewy Bodies (DLB) subjects with cognitive, motor, and behavioral characterization and to enter this data into the PDBP database.
  • Sample Collection: To systematically and longitudinally collect biofluids from DLB subjects and to enter biofluids samples into the PDBP biorepository.
  • Assessment: To obtain autopsy for the pathologic characterization of brain and collection of tissues for additional investigations.
  • Facilitate Collaboration: To promote collaboration across both the DLB consortium sites and with other investigators, including other consortiums outside the US, in order to accelerate biomarker and translational research and the development of therapeutic interventions of LBD.

Enrollment Goals

  • 216 subjects with probable Dementia with Lewy Bodies (DLB) or high likelihood DLB subtype of mild cognitive impairment (MC)  (varying stages of disease.


To participate in this study, please contact one of the following:

Cleveland Clinic Center for Brain Health
Cleveland Clinic (Primary)
Marcia Walker
Clinical Coordinator
University of Miami
Jessica Ferrall
Clinical Coordinator
University of North Carolina
Cary Zik
Clinical Coordinator
University of Pittsburgh
Sarah Payne
Clinical Coordinator
VA Puget Sound Health Care System - University of Washington
Katheryn Woo
Clinical Coordinator
Rush University
Rachel Schade
Clinical Coordinator
University of California San Diego
Lynn Eickholt
Clinical Coordinator
University of Pennsylvania
Liliana Dumitrescu
Clinical Coordinator
Cleveland Clinic Las Vegas

Available Data Types