A Study to Identify Factors Predicting End-of-life Dementia with Lewy Bodies and End-of-life Experiences


About this study

The objectives of this study are to determine the predictors of death within 6 months in individuals with Dementia with Lewy Bodies (DLB), to identify whether a change in caregiver measures can predict approaching end of life of individuals with DLB, and to identify factors that affect quality end of life experiences for persons with DLB and their caregivers.

Dementia with Lewy bodies (DLB) is part of Lewy body dementia, the 2nd-most-common degenerative dementia in the U.S. It is also one of the Alzheimer’s disease-related dementias (ADRDs). Evidence-based models of end-of-life care for ADRDs are insufficient; families face difficult medical decisions with little information for guidance. This is particularly relevant for DLB, where >70% of individuals die of the dementia itself or failure to thrive. Caregivers describe lack of knowledge of what to expect at the end of life as an important driver of negative end-of-life experiences. The proposed study addresses this unmet need. It also addresses the National Institute on Aging’s priority to improve quality of care and quality of life for persons with ADRDs at the end of life and their caregivers. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patient and caregiver willing to participate as a dyad (patients will need a legally authorized representative to consent on their behalf given the requirement for at least moderate dementia, but patients who resists participating in the study will not be enrolled).
  • U.S. residents (i.e., individuals accessing the LBDA from outside the U.S. will be excluded).
  • Patient with a clinical diagnosis of Dementia with Lewy Bodies (DLB).
  • Patient with moderate severity dementia as assessed by the Quick Dementia Rating System (QDRS, with a score of > 12 suggestive of moderate dementia), and caregiver modified telephone interview for cognitive status (TICS-m) score of > 31 to ensure that the caregiver is able to reliably complete study visits. Diagnosis of DLB will be confirmed using the Lewy Body Composite Risk Score (LBCRS, score ≥ 3 consistent with DLB). The QDRS and LBCRS were chosen for inclusion criteria as they are validated caregiver-reported scales and can be used for both the clinical and the virtual cohorts.
  • The participating caregiver must be the person providing the majority of the patient’s informal care (whether the individual with DLB is living at home or in a facility) and attending the majority of the patient’s clinical visits.
  • The carepartner can represent any relationship with the individual with DLB (e.g., spouse, child).
  • The type of relationship will be captured in demographic details to assess the impact of this relationship/role on end of life for the individual with DLB and the caregiver.
  • The participating caregiver must remain the same throughout the study.
  • If the primary caregiver changes (e.g., due to caregiver death), that dyad will drop out of the study.
  • The location of the person with DLB (e.g., home, facility) will be monitored throughout the study for its influence on outcomes and its relationship with informal caregiver responsibilities.

Exclusion Criteria:

  • Individuals < 18 years of age.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Julie Fields, Ph.D., L.P.

Open for enrollment

Contact information:

Leah Forsberg Ph.D., M.S.

(507) 293-9577


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