Dementia With Lewy BodiesNCT04829656
The PACE-DLB Study
An observational study of Dementia With Lewy Bodies, run by University of Florida at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia With Lewy Bodies
- How many people
- 378 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Feb 2021to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan, 48105
University of Virginia
Charlottesville, Virginia, 22903
University of Florida
Gainesville, Florida, 32608
University of Miami
Miami, Florida, 33136
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Identifying Factors Predicting ACcurately End-of-Life in Dementia With Lewy Bodies and Promoting Quality End-of-Life Experiences: the PACE-DLB Study
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.
Read more
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:
- To determine predictors of the end of life (death within 6 months) in the DLB population. Hypotheses: Predictors of death within 6 months for individuals with DLB will include symptoms (e.g. worsening hallucinations, fluctuations) not captured in existing dementia end-of-life prediction tools.
- To identify whether change in caregiver measures can predict the end of life in the DLB. Hypotheses: The investigators hypothesize that there will be worsening caregiver burden, depression, grief, and quality of life preceding the last 6 months of life, controlling for variables such as resilience, support, and living situation.
- 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.
Hypotheses: Location (rural, urban, suburban), provider experience (e.g. specialist vs not), patient residence (e.g. home, skilled nursing), degree of behavioral symptoms, caregiver type (spouse vs child vs other), and caregiver characteristics (self-efficacy, perceived social support, resilience, and coping) will affect patient and informal caregiver experiences at the patient's end of life, including patient and caregiver quality of life and caregiver well-being, depression, burden, grief, and satisfaction with end-of-life care.
Read the detailed description
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.
Based on published clinical series, over half of enrolled individuals with DLB are expected to die over the course of the study. To achieve diverse recruitment, the study includes an in-person cohort where dyads are recruited from Lewy Body Dementia Association Research Centers of Excellence and a novel virtual cohort where dyads are recruited through the Lewy Body Dementia Association and study visits are conducted by telephone. Having a virtual cohort will capture the experiences of individuals with DLB and caregivers not receiving care at specialty centers.
Because the majority of study measures are caregiver-reported, the in-person and virtual groups have identical study measures, except for the Unified Parkinson Disease Rating Scale, completed only in person. Collected measures will include demographics, DLB characteristics (e.g. cognitive, motor, behavioral, sleep, and autonomic symptoms), health care providers and settings, caregiver considerations (e.g. resilience, support, grief, burden), quality of life (for the patient and caregiver), and satisfaction with end of life experiences.
The caregiver will complete a final study visit 3 months after the death of the person with DLB to assess grief, recovery, and quality of the end of life experience. By following dyads through the end of life and death of the person with DLB and the initial bereavement period for the caregiver, the study will identify DLB-specific predictors of the last 6 months of life, changes in caregiver measures that identify the last 6 months of life, and factors which influence quality end of life experiences. These results will inform the content and timing of end-of-life counseling in DLB, help establish quality metrics for end of life care, and identify areas where interventions could potentially improve end of life experiences for individuals with DLB and their caregivers.
- Conditions
- Dementia With Lewy Bodies
- Keywords
- dementia, Lewy bodies, Lewy body, aging, neurology
- Medical subject headings
- Lewy Body Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Cohort | Enrolled via the 5 participating clinics at LBDA Research Centers of Excellence. | |
| Virtual Cohort | Enrolled via the LBDA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: Every 6 months for up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start25 Feb 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 378 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Melissa J Armstrong, MD, MSc, FAAN, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829656
- Sponsor's protocol ID
- IRB202001438
- Other IDs
- 1R01AG068128-01
- Status last verified
- Jan 2026
- First submitted
- 22 Mar 2021
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40808538Wollney 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.
PubMed 39208192Armstrong 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.
PubMed 38617555Armstrong 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.
PubMed 38400528Armstrong 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.
PubMed 34039578
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Factors Predicting ACcurately End-of-Life in Dementia With Lewy Bodies and Promoting Quality End-of-Life Experiences: the PACE-DLB Study
- ClinicalTrials.gov ID
- NCT04829656
- Acronym / sponsor ID
- IRB202001438
- Conditions
- Dementia With Lewy Bodies
- Keywords
- dementia, Lewy bodies, Lewy body, aging, neurology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 378 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Feb 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine predictors of the end of life (death within 6 months) in the DLB population. Hypotheses: Predictors of death within 6 months for individuals with DLB will include symptoms (e.g. worsening hallucinations, fluctuations) not captured in existing dementia end-of-life prediction tools.
- To identify whether change in caregiver measures can predict the end of life in the DLB. Hypotheses: The investigators hypothesize that there will be worsening caregiver burden, depression, grief, and quality of life preceding the last 6 months of life, controlling for variables such as resilience, support, and living situation.
- 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.
Hypotheses: Location (rural, urban, suburban), provider experience (e.g. specialist vs not), patient residence (e.g. home, skilled nursing), degree of behavioral symptoms, caregiver type (spouse vs child vs other), and caregiver characteristics (self-efficacy, perceived social support, resilience, and coping) will affect patient and informal caregiver experiences at the patient's end of life, including patient and caregiver quality of life and caregiver well-being, depression, burden, grief, and satisfaction with end-of-life care.
Detailed description
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.
Based on published clinical series, over half of enrolled individuals with DLB are expected to die over the course of the study. To achieve diverse recruitment, the study includes an in-person cohort where dyads are recruited from Lewy Body Dementia Association Research Centers of Excellence and a novel virtual cohort where dyads are recruited through the Lewy Body Dementia Association and study visits are conducted by telephone. Having a virtual cohort will capture the experiences of individuals with DLB and caregivers not receiving care at specialty centers.
Because the majority of study measures are caregiver-reported, the in-person and virtual groups have identical study measures, except for the Unified Parkinson Disease Rating Scale, completed only in person. Collected measures will include demographics, DLB characteristics (e.g. cognitive, motor, behavioral, sleep, and autonomic symptoms), health care providers and settings, caregiver considerations (e.g. resilience, support, grief, burden), quality of life (for the patient and caregiver), and satisfaction with end of life experiences.
The caregiver will complete a final study visit 3 months after the death of the person with DLB to assess grief, recovery, and quality of the end of life experience. By following dyads through the end of life and death of the person with DLB and the initial bereavement period for the caregiver, the study will identify DLB-specific predictors of the last 6 months of life, changes in caregiver measures that identify the last 6 months of life, and factors which influence quality end of life experiences. These results will inform the content and timing of end-of-life counseling in DLB, help establish quality metrics for end of life care, and identify areas where interventions could potentially improve end of life experiences for individuals with DLB and their caregivers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Cohort | – | –Enrolled via the 5 participating clinics at LBDA Research Centers of Excellence. |
| Virtual Cohort | – | –Enrolled via the LBDA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictors of the end of life (death within 6 months) in the DLB population
Time frame: Every 6 months for up to 3 years
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.
Identify whether change in caregiver measures can predict the end of life in the DLB
Time frame: Every 6 months for up to 3 years
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.
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
Time frame: Every 6 months for up to 3 years
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Derived from this study: PubMed 40808538Armstrong 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.
- Derived from this study: PubMed 39208192Wollney 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.
- Derived from this study: PubMed 38617555Armstrong 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.
- Derived from this study: PubMed 38400528Armstrong 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.
- Derived from this study: PubMed 34039578Armstrong 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.
Related trials for Dementia With Lewy Bodies
RecruitingEarly Phase 1
[18F]ACI-15916 PET in α-synucleinopathies
Parkinson's Disease (PD), Multiple System Atrophy (MSA)
Recruiting
Evaluating How Red-light Therapy Applied to the Head Affects Symptoms, Daily Life, and Brain Activity in People With Dementia With Lewy Bodies
Photobiomodulation, Dementia With Lewy Bodies
RecruitingObservational study
Distinguishing Between Alzheimer's Disease, Lewy Body Dementia, and Parkinson's Disease
Alzheimer's Disease, Lewy Body Dementia
Not yet recruitingObservational study
Digital Health Technologies for Progressive Supranuclear Palsy and Dementia With Lewy Bodies
Progressive Supranuclear Palsy(PSP), Dementia With Lewy Bodies (DLB)
RecruitingObservational study
Parkinson's Disease and Movement Disorders Clinical Database
Parkinson Disease, Parkinson Disease Dementia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa J Armstrong, MD, MSc, FAAN principal investigator
University of Florida
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia With Lewy Bodies, run by University of Florida at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictors of the end of life (death within 6 months) in the DLB population (time frame: Every 6 months for up to 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04829656, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.