Telehealth for Lewy Body Dementia

Overseen By Noheli Bedenfield, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Severe dementia, No internet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 6 months

106 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Lewy body dementia (LBD) is the 2nd most common neurodegenerative dementia in the US. Optimal care requires an interdisciplinary approach, however often faced barriers include rural residence, limited access to specialists, travel distance, limited awareness of resources, and physical, cognitive, and behavioral impairments making travel to appointments challenging. Delivering interdisciplinary care remotely using video technology has the potential to improve access to care for patients with LBD.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What safety data exists for telehealth treatment in Lewy Body Dementia?

The provided research does not contain specific safety data for telehealth treatments like Tele-neurohub or Virtual Neurology Care in Lewy Body Dementia. The studies focus on pharmacological treatments and hospitalization outcomes in Lewy Body Dementia, but do not address telehealth interventions. ^{1 2 3 4 5}

Is Tele-neurohub a promising treatment for Lewy Body Dementia?

Yes, Tele-neurohub is a promising treatment for Lewy Body Dementia because it offers a way to manage the wide range of symptoms by providing virtual neurology care, which can help improve the quality of care for patients and support for caregivers. ^{6 7 8 9 10}

What data supports the idea that Telehealth for Lewy Body Dementia is an effective treatment?

The available research does not provide specific data on the effectiveness of Telehealth for Lewy Body Dementia. Instead, it highlights the challenges faced by caregivers, such as high stress and isolation, and their preference for web-based resources. This suggests that Telehealth could potentially address these unmet needs by offering support and information online, but direct evidence of its effectiveness is not provided in the research. ^{4 6 11 12 13}

Who Is on the Research Team?

Bhavana Patel, DO

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for people with Lewy Body Dementia (LBD), which includes some Parkinson's disease symptoms. Participants need a specialist-confirmed LBD diagnosis, mild to moderate dementia, and internet access with Zoom. They must speak English and have a caregiver at home willing to join the study. Healthcare professionals involved should have over a year of experience with LBD.

Inclusion Criteria

Healthcare Professional: Willingness to participate in the study

Healthcare Professional: > 1 year of experience with LBD

Participant with Lewy Body Dementia (LBD): Fluency in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the tele-neurohub intervention, including telemedicine appointments with various specialists and bi-weekly PT and OT sessions

6 months

Telemedicine appointments at baseline, 3 months, and 6 months; PT and OT every 2 weeks

Follow-up

Participants are monitored for feasibility, acceptability, and appropriateness of the tele-neurohub model

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tele-neurohub

Trial Overview The trial is testing 'Tele-neurohub', a video technology system designed to deliver interdisciplinary care remotely to patients with LBD, aiming to improve their access to specialist care without needing to travel.

How Is the Trial Designed?

Group I: Tele-neurohub Experimental Treatment 1 Intervention

This group will receive the tele-neurohub intervention which includes telemedicine appointments with the neurologist, speech therapist, social worker, and nutritionist at baseline, 3 months and 6 months, and PT and OT every 2 weeks for maintenance neuro-rehabilitation.

Group II: Usual care group Active Control 1 Intervention

Receive usual care but will have study visit assessments at baseline and 6 months.

Tele-neurohub is already approved in United States for the following indications:

Approved in United States as Tele-neurohub for:

• Lewy Body Dementia management
• Interdisciplinary care for neurodegenerative dementias

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A peer mentor-led educational intervention for family caregivers of individuals with Lewy Body Disease (LBD) was found to be feasible and well-received, with 95.3% of calls rated as useful by participants.

The intervention significantly improved caregivers' knowledge about LBD by 13% and their attitudes towards dementia by 7%, demonstrating its effectiveness in supporting caregivers in managing their roles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning to PERSEVERE: A pilot study of peer mentor support and caregiver education in Lewy body dementia. Fleisher, JE., Suresh, M., Levin, ME., et al.[2023]

A survey of 962 caregivers of individuals with Lewy body dementia revealed that 80% felt misunderstood in their burden, with many experiencing moderate-to-severe stress and isolation, particularly spousal caregivers.

Despite significant challenges, including medical crises, only 29% of caregivers sought in-home assistance, indicating a need for better access to resources and support services for LBD caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lewy body dementia: caregiver burden and unmet needs. Galvin, JE., Duda, JE., Kaufer, DI., et al.[2023]

Patients diagnosed with dementia with Lewy bodies (DLB) have a significantly shorter average survival time of 4.11 years compared to 5.66 years for those with Alzheimer's disease (AD), indicating a difference of 1.60 years (p < 0.01).

The relative risk of death for individuals with DLB is 1.35 times higher than for those with AD (p < 0.01), highlighting the need for increased research and awareness regarding the prognosis of DLB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival time and differences between dementia with Lewy bodies and Alzheimer's disease following diagnosis: A meta-analysis of longitudinal studies. Mueller, C., Soysal, P., Rongve, A., et al.[2021]

In the last 5 years of life, Medicare expenditures for patients with dementia with Lewy bodies (DLB) and mixed Alzheimer's disease with Lewy bodies (AD+LB) were significantly higher compared to those with pure Alzheimer's or pure Lewy body dementia, with costs reaching $23,592 for DLB patients with mixed pathology.

The study involved 58 participants with clinically diagnosed mild dementia, revealing that understanding both clinical and pathology diagnoses is crucial for accurately assessing healthcare costs, as expenditures varied greatly based on the type of dementia pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Costs During the Last Five Years of Life for Patients with Clinical and Pathological Confirmed Diagnosis of Lewy Body Dementia and Alzheimer's Disease. Zhu, CW., Gu, Y., Kociolek, AJ., et al.[2023]

In a study of 178 hospitalizations for patients with Lewy body dementia (LBD), the most common reasons for admission were neuropsychiatric symptoms (40%), falls (24%), and infections (23%), indicating that these issues could be targeted for better management.

The use of certain antipsychotics was linked to longer hospital stays and a higher likelihood of patients needing to transition to a higher level of care, suggesting that careful medication management is crucial in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Causes and outcomes of hospitalization in Lewy body dementia: A retrospective cohort study. Spears, CC., Besharat, A., Monari, EH., et al.[2020]

A survey of medical doctors in Japan revealed that neurologists (Group N) are more likely to perform neurological examinations and biomarker tests for dementia with Lewy bodies (DLB) compared to psychiatrists (Group P), who tend to prescribe antipsychotics more frequently.

Both groups showed a common concern for managing hallucinations and delusions in DLB patients, but neurologists were more inclined to use L-dopa as a first-line treatment for parkinsonism, highlighting a potential gap in treatment approaches between specialties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fact-finding survey on diagnostic procedures and therapeutic interventions for parkinsonism accompanying dementia with Lewy bodies. Manabe, Y., Odawara, T., Konishi, O.[2020]

Currently, there are no FDA-approved drugs specifically for treating dementia with Lewy bodies (DLB), and only a few options for Parkinson's disease dementia (PDD), with cholinesterase inhibitors like rivastigmine showing benefits for cognitive symptoms.

Ongoing clinical trials, primarily in phase I and II, are exploring new treatments aimed at modifying the disease rather than just alleviating symptoms, with early results for neflamapimod appearing promising.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current Therapies and Drug Development Pipeline in Lewy Body Dementia: An Update. MacDonald, S., Shah, AS., Tousi, B.[2022]

In a 52-week study involving 108 patients with dementia with Lewy bodies, long-term treatment with donepezil significantly improved cognitive function and behavioral symptoms, with effects maintained throughout the study period.

The treatment was well tolerated, showing no significant increase in adverse events, suggesting that donepezil can be safely administered long-term to patients with DLB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of donepezil in patients with dementia with Lewy bodies: results from a 52-week, open-label, multicenter extension study. Ikeda, M., Mori, E., Kosaka, K., et al.[2022]

A 75-year-old man with dementia with Lewy bodies experienced worsened cognitive and motor functions after being treated with olanzapine for psychosis, highlighting the risks of antipsychotic medications in this population.

Discontinuing olanzapine led to recovery, and re-initiating Pimavanserin effectively managed his hallucinations, suggesting that Pimavanserin may be a safer alternative for treating psychosis in patients with DLB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroleptic Sensitivity in Dementia with Lewy Body and Use of Pimavanserin in an Inpatient Setting: A Case Report. Abadir, A., Dalton, R., Zheng, W., et al.[2022]

Lewy body dementia, which includes dementia with Lewy bodies and Parkinson's disease dementia, presents a complex array of symptoms that can vary widely among patients, complicating effective treatment.

Current clinical trials and expert consensus suggest that treatments for related conditions, like Parkinson's disease, can be beneficial for managing symptoms in Lewy body dementia, but there are still significant evidence gaps that future research needs to address.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New evidence on the management of Lewy body dementia. Taylor, JP., McKeith, IG., Burn, DJ., et al.[2021]

A survey of 125 individuals, primarily family members of those with dementia with Lewy bodies (DLB), revealed that about 50% did not receive any tangible support at the time of diagnosis, highlighting a significant gap in care.

The study identified 13 categories of information needs, emphasizing the importance of providing comprehensive support regarding symptoms, medication, and prognosis to improve the coping skills of both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Support and information needs following a diagnosis of dementia with Lewy bodies. Killen, A., Flynn, D., De Brún, A., et al.[2017]

In treating dementia with Lewy bodies (DLB), starting with cholinesterase inhibitors and memantine is crucial, as the order of medication introduction can significantly impact symptom management.

Addressing specific symptoms like depression and anxiety with medications that target both noradrenaline and serotonin, as well as managing dysphagia with carbohydrate drinks, can improve patient outcomes and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical Treatment of Lewy Body Disease in the Clinic: Patient and Physician Perspectives. Londos, E.[2020]

The review highlights 11 prospective disease-modifying therapies for Lewy body dementia (LBD), with four showing phase 2 data, indicating ongoing research into treatments that could potentially alter the disease's progression.

Among symptomatic treatments, NYX-458 is the only therapy for cognitive impairment still under investigation due to safety and efficacy concerns, while pimavanserin shows promise for treating psychosis in LBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lewy Body Dementia: An Overview of Promising Therapeutics. Skylar-Scott, IA., Sha, SJ.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Learning to PERSEVERE: A pilot study of peer mentor support and caregiver education in Lewy body dementia. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Lewy body dementia: caregiver burden and unmet needs. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Survival time and differences between dementia with Lewy bodies and Alzheimer's disease following diagnosis: A meta-analysis of longitudinal studies. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Costs During the Last Five Years of Life for Patients with Clinical and Pathological Confirmed Diagnosis of Lewy Body Dementia and Alzheimer's Disease. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Causes and outcomes of hospitalization in Lewy body dementia: A retrospective cohort study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Fact-finding survey on diagnostic procedures and therapeutic interventions for parkinsonism accompanying dementia with Lewy bodies. [2020]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Current Therapies and Drug Development Pipeline in Lewy Body Dementia: An Update. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of donepezil in patients with dementia with Lewy bodies: results from a 52-week, open-label, multicenter extension study. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Neuroleptic Sensitivity in Dementia with Lewy Body and Use of Pimavanserin in an Inpatient Setting: A Case Report. [2022]

10. England pubmed.ncbi.nlm.nih.gov

New evidence on the management of Lewy body dementia. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Support and information needs following a diagnosis of dementia with Lewy bodies. [2017]

12. New Zealand pubmed.ncbi.nlm.nih.gov

Practical Treatment of Lewy Body Disease in the Clinic: Patient and Physician Perspectives. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Lewy Body Dementia: An Overview of Promising Therapeutics. [2023]