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?

This trial explores a new method to assist people with Lewy Body Dementia (LBD) by using video technology to connect them with a team of health specialists. The goal is to simplify access to necessary care without requiring long-distance travel, which is often challenging for those with LBD. Participants will receive either the usual care or video appointments with specialists such as neurologists and therapists through the Tele-neurohub, a telehealth service. The trial seeks individuals diagnosed with mild to moderate LBD who have internet access and a caregiver at home willing to assist. As an unphased trial, this study offers a unique opportunity to enhance care accessibility and quality for LBD patients through innovative telehealth solutions.

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 prior data suggests that this telehealth approach is safe for patients with Lewy Body Dementia?

Research has shown that specific safety information for telehealth treatments like Tele-neurohub is lacking. However, telehealth is generally considered safe. It involves virtual appointments with healthcare professionals, enabling patients to receive care without the need to travel, which can reduce stress and physical strain. Although direct safety data for Tele-neurohub is unavailable, telehealth methods are widely used and approved for many conditions, indicating they are generally safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the tele-neurohub because it offers a comprehensive, virtual approach to managing Lewy Body Dementia, contrasting with traditional in-person visits. Unlike standard treatments, which often involve separate appointments with various specialists, this method integrates telemedicine sessions with a neurologist, speech therapist, social worker, and nutritionist, all from the comfort of a patient's home. Additionally, the inclusion of regular physical and occupational therapy via telehealth every two weeks supports continuous neuro-rehabilitation. This approach not only enhances accessibility and convenience but also aims to provide holistic, coordinated care, potentially improving patient outcomes by addressing multiple aspects of the condition simultaneously.

What evidence suggests that the Tele-neurohub is effective for Lewy body dementia?

Research has shown that telehealth can help manage Lewy Body Dementia (LBD). Studies have found that video technology can make it easier for people with LBD, especially those in rural areas, to access specialists. In this trial, participants in the Tele-neurohub arm will receive virtual appointments with a team of experts, including a neurologist, speech therapist, social worker, and nutritionist. This approach manages the many symptoms of LBD by providing comprehensive care without the need to travel. Early findings suggest that this method improves health for both patients and caregivers by facilitating access to necessary care. ^{1 2 3 4 6}

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 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]

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]

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]

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 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]

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]

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]

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05014971

NCT05014971 | Telehealth in Lewy Body Dementia A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.

2. reporter.nih.gov reporter.nih.gov/search/14E9CE024F8FC5D27598B8961CAA4A01A2FFCEB861BF/project-details/11101336

Project Details After adapting the care model to virtual delivery, I will conduct a pilot randomized, controlled clinical trial including 30 individuals with LBD and their ...

3. withpower.com withpower.com/trial/phase-parkinson-disease-10-2021-18505

Telehealth 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 ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05014971/telehealth-in-lewy-body-dementia

Telehealth in Lewy Body Dementia Delivering interdisciplinary care remotely using video technology has the potential to improve access to care for patients with LBD.

5. lbd.neurology.ufl.edu lbd.neurology.ufl.edu/tele-lbd/

Multi-Stakeholder Engagement for Interdisciplinary Telehealth ... The overarching goal of this study is to improve patient and caregiver health outcomes by increasing access to specialty care for individuals with LBD and their ...

6. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13674

Lewy body dementia: Overcoming barriers and identifying ... Indeed, results from the DIAMOND Lewy Study suggest that diagnosis of LBD takes twice as long as AD from referral. According to current criteria ...