The PACE-DLB Study

NCT04829656 | Completed

• 2 other identifiers: IRB2020014381R01AG068128-01
• Study Type: observational
• Target: 378
• Locations: 1 country
• Sites: 5

Brief Summary

The PACE-DLB Study is for people with at least moderate dementia with Lewy bodies (DLB) and their primary caregiver. The study's goals are to learn more about the experiences of people with DLB and their caregivers as DLB progresses, and what happens as the end of life of the person with DLB approaches. Participants are enrolled through one of five Lewy Body Dementia Association (LBDA) Research Center of Excellence clinics, or directly via the LBDA. People with DLB will enroll into the study along with their primary informal caregiver, such as the family member or friend who is involved in most of their care and attends the majority of their medical appointments. A legally authorized representative (LAR) for the person with DLB will consent to participate in the study on the person's behalf. If the person with DLB resists taking part in the study, the pair will not be enrolled. The study consists of questionnaires about the progression of the person's dementia and the experiences of the caregiver. The person with DLB will complete one questionnaire themselves if they are able to. If the pair is enrolled at a LBDA Research Center of Excellence clinical site, and completes study visits in-person, a brief physical exam of the person with DLB will be completed by a clinician. Study participation will last for three years, or until the person with DLB dies. Study visits take place every six months, either virtually or in person at a clinical study site. If the person with DLB dies during the study, the caregiver will complete one final virtual study visit three months afterward. Specific Aims of the PACE-DLB Study:

1. 1.To determine predictors of the end of life (death within 6 months) in the DLB population.
2. 2.To identify whether change in caregiver measures can predict the end of life in the DLB.
3. 3.To identify the impact of demographics, health care factors, and specific DLB symptoms on patient quality of life and caregiver experiences at the end of life of the person living with DLB.

Conditions

Dementia With Lewy Bodies

Keywords

dementia; Lewy bodies; Lewy body; aging; neurology

Outcome Measures

Primary Outcomes (3)

• Predictors of the end of life (death within 6 months) in the DLB population

  The investigators define a variable that predicts the end of life as a variable changing substantially (e.g., quick drop of quality of life) once the patient enters last six months of life. The investigators will model and estimate the longitudinal trajectories of all potential candidate variables to identify those with significantly different trajectory patterns in the last six months of life.

  Every 6 months for up to 3 years

• Identify whether change in caregiver measures can predict the end of life in the DLB

  The investigators will collect caregiver measures such as quality of life, burden, depression, dementia-related grief, support, resilience, and coping for all dyads (virtual and clinical cohorts). The investigators will assess the correlation between (1) caregiver burden, depression, grief, and quality of life scores and (2) change in caregiver burden, depression, grief, and quality of life scores with the last 6 months of life of the person with DLB.

  Every 6 months for up to 3 years

• Identify the impact of demographics with specific DLB symptoms on patient quality of life and caregiver experiences at the end of life of the person living with DLB

  Using both the virtual and clinical cohorts, the investigators will identify which patient demographics (e.g. age, gender, sex, race/ethnicity, disease duration, level of education), caregiver demographics (e.g. age, gender, sex, race/ethnicity, relationship to patient, level of education), disease characteristics (e.g. overall symptom burden, cognition, motor function, neuropsychiatric symptoms, functional status, fluctuations, sleep-related symptoms, autonomic symptoms, medications), elements of care (rural/urban, type of healthcare provider, patient residence), and caregiver measures (self-efficacy, social support, coping skills) drive patient (QoL) and caregiver (QoL, depression, burden, grief, resilience) outcomes. These will be assessed across the disease course and specifically at the end of life (at the last clinical visit prior to death).

  Every 6 months for up to 3 years

Study Arms (2)

Clinical Cohort

Enrolled via the 5 participating clinics at LBDA Research Centers of Excellence.

Virtual Cohort

Enrolled via the LBDA.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at five LBDA Research Centers of Excellence clinics may enroll into the study if they meet inclusion criteria. Clinics participating in the study are located at the University of Florida, Gainesville, FL; University of Miami, Miami, FL; University of Virginia, Charlottesville, VA; University of Michigan, Ann Arbor, MI; and the Mayo Clinic, Rochester, MN. People who have indicated interest in research opportunities through the LBDA mailing listserv will be emailed study information, including how to enroll.

You may qualify if:

• 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 DLB
• Patient with moderate severity dementia as assessed by the Quick Dementia Rating System (QDRS, with a score of \>12 OR ≥2 in at least 3 domains suggestive of moderate dementia)
• Caregiver telephone interview for cognitive status (TICS) score of \>31 to ensure that the caregiver is able to reliably complete study visits
• Patient participant expected to live at least 6 months (so that at least a baseline visit and 1 follow up visits is expected to be completed)

You may not qualify if:

• Patient participant diagnosed with dementia of less than moderate severity
• Patient with dementia resists participation
• Non-U.S. residents
• Patient participant with dementia not expected to live at least 6 months
• Virtual cohort ONLY: Patient participant receives medical care from a LBDA Research Centers of Excellence clinic

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• University of Florida: lead

Study Sites (5)

University of Florida

Gainesville, Florida, 32608, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Michigan

Ann Arbor, Michigan, 48105, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (5)

• Armstrong MJ, Wollney E, Li Z, Dai Y, LaBarre B, Wang T, Sovich K, Jury HF, Galvin JE, Henriquez AM, Maixner SM, Paulson HL, Fields JA, Lunde A, Boeve BF, Manning C, Taylor AS, Baker ZG. Caregiver experiences after the death of a person with dementia with Lewy bodies: A mixed-methods analysis. J Alzheimers Dis. 2025 Oct;107(3):1097-1113. doi: 10.1177/13872877251365218. Epub 2025 Aug 14.

  PMID: 40808538 DERIVED

• Wollney E, Sovich K, LaBarre B, Maixner SM, Paulson HL, Manning C, Fields JA, Lunde A, Boeve BF, Galvin JE, Taylor AS, Li Z, Fechtel HJ, Armstrong MJ. End-of-life experiences in individuals with dementia with Lewy bodies and their caregivers: A mixed-methods analysis. PLoS One. 2024 Aug 29;19(8):e0309530. doi: 10.1371/journal.pone.0309530. eCollection 2024.

  PMID: 39208192 DERIVED

• Armstrong MJ, Dai Y, Sovich K, LaBarre B, Paulson HL, Maixner SM, Fields JA, Lunde AM, Forsberg LK, Boeve BF, Manning CA, Galvin JE, Taylor AS, Li Z. Caregiver Experiences and Burden in Moderate-Advanced Dementia With Lewy Bodies. Neurol Clin Pract. 2024 Jun;14(3):e200292. doi: 10.1212/CPJ.0000000000200292. Epub 2024 Apr 10.

  PMID: 38617555 DERIVED

• Armstrong MJ, LaBarre B, Sovich K, Maixner SM, Paulson HL, Manning C, Fields JA, Lunde A, Forsberg L, Boeve BF, Galvin JE, Taylor AS, Li Z. Patient- and proxy-reported quality of life in advanced dementia with Lewy bodies. Alzheimers Dement. 2024 Apr;20(4):2719-2730. doi: 10.1002/alz.13745. Epub 2024 Feb 23.

  PMID: 38400528 DERIVED

• Armstrong MJ, Paulson HL, Maixner SM, Fields JA, Lunde AM, Boeve BF, Manning C, Galvin JE, Taylor AS, Li Z. Protocol for an observational cohort study identifying factors predicting accurately end of life in dementia with Lewy bodies and promoting quality end-of-life experiences: the PACE-DLB study. BMJ Open. 2021 May 26;11(5):e047554. doi: 10.1136/bmjopen-2020-047554.

  PMID: 34039578 DERIVED

MeSH Terms

Conditions

Lewy Body Disease; Dementia

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Melissa J Armstrong, MD, MSc, FAAN

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2021
• First Posted: April 2, 2021
• Study Start: February 25, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Locations

US (5)