Men and women who act out their dreams at night may not face the same risks for dementia later in life.

A new international study finds that men with REM sleep behavior disorder (RBD)—a sleep condition linked to vivid, physical dream enactment—show greater early brain shrinkage than women with the same disorder. Those brain changes appear in the same areas that later deteriorate in dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD). The discovery suggests that women’s brains may have natural biological protections that slow or reduce the damage that can lead from RBD to dementia.

The connection between RBD and dementia

 In healthy REM sleep, the brain turns off muscle activity so that dream content does not result in movement. In RBD, that “off switch” fails, and people may talk, punch, kick, or fall out of bed as they physically act out their dreams. On its own, RBD can be disruptive and even dangerous. But researchers have learned that it is also one of the earliest warning signs of certain brain diseases. More than 70% of people with RBD eventually develop a synucleinopathy—a disease marked by abnormal buildup of a protein called alpha-synuclein. The most common of these are Parkinson’s disease and DLB.

Because RBD can appear years or even decades before dementia symptoms start, it offers a unique window into the earliest stages of neurodegeneration.

A closer look at men’s and women’s brains 

The new study, led by scientists at the University of Montreal and published in Nature Communications, analyzed brain MRI scans from 888 people—408 with confirmed RBD and 480 healthy controls, meaning people with no known major brain disorders. The researchers examined the cortex, which is the thin outer layer of the brain that supports thinking, voluntary movement, and sensation. When the cortex becomes thinner, that signals a loss of brain cells, a process that researchers call atrophy.

The results showed clear differences between the sexes:

• Men with RBD had much more cortical thinning than women, particularly in the back and top parts of the brain—regions that help with movement, coordination, and visual processing.
• Women had far less thinning, even though they were similar in age and disease severity.
• Among healthy volunteers, there were no meaningful sex differences, suggesting the gap appears only once the disease process begins.

In short, men’s brains showed more early damage, while women’s brains seemed to resist it.

Searching for the reason behind women’s resilience

To find out why, the team looked at gene activity patterns in healthy brain tissue and compared them with the brain regions that stayed intact in women with RBD. They discovered that these protected regions had higher expression of genes linked to estrogen-related receptors. One of the genes, ESRRG, was especially active in brain tissue compared to other organs, suggesting it plays a brain-specific protective role. This kind of molecular activity could help female brains withstand early damage from toxic proteins such as misfolded alpha-synuclein, which accumulate in Lewy body dementias.

What this means for dementia risk

The findings support the idea that sex-linked biological factors influence the path from RBD to dementia.

• For men, more widespread cortical thinning could indicate a faster or higher-risk trajectory toward diseases like DLB and PDD.
• For women, estrogen-related genetic activity may provide some protection, delaying or reducing early brain damage.

This does not mean women are immune—many still develop dementia—but understanding these differences may help doctors identify who is most at risk and why. It also highlights potential targets for future therapies that could strengthen the brain’s systems in both sexes.

Key takeaways for the public 

• RBD is a powerful early warning sign for Lewy body–related dementias. Anyone who acts out dreams during sleep should be evaluated by a physician.
• Monitoring over time is key. Regular follow-up visits can help detect early cognitive or movement changes that suggest progression.
• Sex matters. Men and women may follow different paths from RBD toward dementia. Understanding these differences could lead to more personalized monitoring and treatment strategies.
• Research continues. Scientists are now studying whether targeting estrogen-related pathways could slow neurodegeneration.

Putting it all together

This large international study shows that men’s brains show earlier and more widespread atrophy in REM sleep behavior disorder, while women’s brains may benefit from protective, estrogen-related genes.

RBD remains one of the most important early clues to who may develop Lewy body–related dementia. By uncovering how sex differences shape that journey, researchers are getting closer to understanding why some brains are more resilient—and how that resilience might be shared with everyone.

REFERENCE:

Filiatrault, M., Ayral, V., Tremblay, C. et al. Estrogen-related receptor gene expression associates with sex differences in cortical atrophy in isolated REM sleep behavior disorder. Nat Commun 16, 9016 (2025). https://doi.org/10.1038/s41467-025-63829-w

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In recognition of National Family Caregivers Month we are spotlighting research studies for care partners. If you or someone you provide care for is participating in a clinical trial, you already know that care partners play a key role in research studies. In fact, the care partner is such an important source of information that many studies actually require a care partner to participate in addition to the person living with Lewy.

But did you know that there are many studies that are focused on the care partner rather than on the person living with Lewy? In these kinds of studies, researchers examine the caregiving experience and try to find ways to improve quality of life for the care partner and the person living with Lewy.

In many cases, these studies can be completed from the comfort of your own home. Often, you can connect with the study team via video conferencing rather than visiting a clinic.

A few examples of this kind of study include:

• The Lewy Body Dementia Caregiver Study is gathering information about day-to-day stressors associated with LBD caregiving, with an eye toward future development of strategies to reduce their impact on quality of life.
• The I-Care-Rural pilot study is evaluating an app for rural care partners with the goal of reducing care partner stress and improving certain symptoms of the person living with Lewy.
• The Caregiver Bootcamp study is testing a prototype educational program for family and friends of people who have been recently diagnosed with dementia.
• The LEAD study is trialing a guided tool designed to improve advance care planning by people living with Lewy and their care partners by focusing on communication and the development of mutual understanding.
• The FinLe study is developing a web-based tool that may help people with dementia and their care partners accomplish personalized financial management and legal planning.
• The CareEx study is focused on learning more about extended family care partners, such as grandchildren, siblings, nieces/nephews and step-kin.
• The PERSEVERE study is testing an educational program for family care partners of people living with Lewy.

You can see more information about these and other studies – either for care partners or for people living with Lewy – you can always visit the LBDA clinical trials page, which contains information on currently recruiting studies.

New studies launch frequently. To be kept up to date by email when new studies launch that match your characteristics and interests, consider signing up for the Lewy Trial Tracker.

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What is this study about?

The purpose of the study is to:

• Test how usable and acceptable Brain CareNotes is for rural caregivers.
• See if a larger trial in rural communities is possible.
• Estimate how much the app can reduce caregiver burden and patient symptoms compared to an education-only app.

What is involved?

• Participants will take part for 6 months.
• Participants will complete three assessments.
• Beginning of study
• At 3 months
• At 6 months
• Participants are randomly assigned to one of two groups:
• Group 1 – Brain CareNotes app: interactive app with caregiver support, educational resources, and access to a trained care coach.
• Group 2 – Dementia Guide Expert app: education-only app about dementia.
• Those in the Brain CareNotes group use the app every two weeks to track symptoms and access personalized advice. They can also message a care coach for support.

Who can participate?

Caregivers who are:

• Age 18 or older
• Able to read, understand, and communicate in English
• Unpaid rural caregiver of person diagnosed with Alzheimer’s disease or a related dementia (ADRD) at any stage
• Reside at a rural address
• Provide support for person with ADRD who resides in the community and is not a resident of a nursing home

Study Site

Study Funder/Sponsor

The study is funded by the National Institutes of Health and sponsored by the Indiana University School of Public Health.

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What is this study about?

The study is testing an online educational program designed to improve caregivers’ confidence and ability in caring for a loved one with dementia. It also explores how the program may improve caregivers’ overall well-being and quality of life for both caregivers and the person living with dementia.

What is involved?

Participants will take part in a 5-week online program that combines live sessions with self-paced activities. The program includes education, skill-building, and interactive exercises on topics such as coping with a diagnosis, daily caregiving, safety, building a support network, and self-care. Participants will also complete evaluations to share feedback about the program’s usability and effectiveness.

Who can participate?

A person may be able to participate if they:

• Are 18 years of age or older
• Are able to read and understand English
• Are actively caring for someone living with dementia or cognitive impairment
• Serve as primary or co-primary caregiver
• Have access to the internet, as program sessions will be held over Zoom

Study Site

Study Funder/Sponsor

This study is funded by the National Institute on Aging (NIA)

For more information, please contact Karah Alexander, Program Coordinator, 404.544.9916 or email boot.camp@emory.edu. You may also complete the screening form at https://forms.office.com/r/AZTW65Jbg5.

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Lewy body dementia (LBD) includes Parkinson’s disease dementia (PDD) and dementia with Lewy bodies (DLB). Lewy Body dementia it is the second most common form of progressive dementia after Alzheimer’s disease. It happens when abnormal protein deposits—called Lewy bodies—build up in the brain and disrupt how brain cells work together. LBD is unique among dementias in how widespread symptoms can be. LBD affects not just memory and thinking, but also movement, mood, sleep, and behavior, presenting ongoing challenges throughout the day and the night.

What We Need to Know about Care for People Experiencing LBD

All forms of dementia may involve good days and bad days, but LBD is unique in how rapidly things can change throughout the day. LBD also has more sleep disruptions than other forms of dementia, making nights demanding as well as days. But we know surprisingly little about patterns of symptoms throughout the day and night.  Understanding how and when symptoms change would could help caregivers effectively respond to those symptoms, and minimize stress. Caregivers for LBD need interventions in the moments when problems are occurring.

Researchers at the University of Texas at Austin have received funding from the National Institutes of Health/National Institute on Aging to study LBD caregivers’ daily experiences. By learning more about daily experiences, researchers may be able to develop more effective interventions to address challenges at the time they arise.

What is being done?

Dr. Karen Fingerman at the University of Texas at Austin, an expert in understanding older adults’ family lives, and how spouses, parents, children, and other relatives support one another in daily life, is leading a study called the Lewy Body Dementia Caregiver Study. This study examines challenges that occur in everyday life for LBD caregivers in real world settings.

Importantly, all participation is by phone and virtual and the study team is looking for volunteers from all around the US.

Caregivers first complete a phone interview (the baseline interview) where they are asked to share their overall experiences helping their family member with LBD.

Then, caregivers wear FitBits that track their heart rate, sleep cycles, and physical activity such as sitting or lying down, or being mildly or very active. The researchers also provide caregivers with a smartphone that is easy to use: It has only the apps needed to answer brief surveys about symptoms, caregiving, and stress throughout the day for 4 days. The research team helps walk the caregiver through the process of using the app. If the person experiencing LBD is also willing to participate, they wear a FitBit as well. This allows us to compare the stress that both people experience and their patterns of sleep.

Participants receive compensation for their participation in each component of the study in the form of gift cards of their choice or a check. The research team keeps in touch with the participants throughout the study. Caregivers who have participated report feeling supported throughout the daily data collection.

What has the study team learned so far?

The researchers have already learned several important things about caregiving for LBD. For example, caregivers sometimes experience feelings of isolation because the family member experiencing LBD does not wish to discuss their experiences with the disease. So far in the study, approximately half of the family members with LBD were willing to talk with their caregiver about the disease, but close to half were not at all, a little or only somewhat likely to talk about it.

Healthcare professionals also seem to lack information about LBD. Over 40% of caregivers in the study so far reported receiving little or poor quality information about the disease, and over 40% also reported that they had to provide health care professionals with information about LBD. The plus side of that is that 60% of caregivers were receiving adequate information from their health care providers.

Some participants also reported rewards from caregiving: 49% of participants agreed that caregiving made them feel more useful, and 73% of participants agreed that caregiving made them feel needed.

The research team has also found large swings in the frequency of agitation. On average family members with LBD were agitated 6 times per day, but the number of agitation events ranged from “not at all” on some days, to one participant who experienced 24 episodes of agitation in a single day.

How can I get involved?

To learn more about this study, you can call the study team at 512-471-0618.

You can also visit the LBDA page for this study or the study team’s webpage.

Or if you have questions about the study or wish to enroll, you can also email caregivers@austin.utexas.edu.

For more information on clinical trials and other studies that might be right for you, LBDA encourages you to visit our clinical trials page. To stay up-to-date on new studies when they launch, you can also sign up for LBDA’s Lewy Trial Tracker.

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New data from the full 32-week open-label extension phase of the RewinD-LB trial continue to suggest that the study drug, neflamapimod, may slow cognitive decline in dementia with Lewy bodies (DLB). In addition, lab tests performed during the study suggest that the drug may work by slowing underlying degeneration of brain cells.

What was the RewinD-LB trial?

RewinD-LB was a Phase 2b trial of the experimental drug neflamapimod in people with DLB. A prior Phase 2a trial showed benefit on cognitive decline, particularly for people without evidence of co-existing Alzheimer’s disease (AD). The RewinD-LB trial sought to replicate the findings of the earlier trial, but focused only on people with DLB and no evidence of AD.

In the main phase of RewinD-LB, researchers did not find the same kinds of positive results as they did in the original trial. However, the researchers learned that the drug capsules used in the main phase of the trial were not delivering the same level of drug as they did in the prior Phase 2a trial, possibly explaining the discrepancy in findings.

After the main phase of RewinD-LB, all participants were offered a chance to take the study drug in a phase of the trial called an open-label extension. In the extension phase, all volunteers take active drug; there is no placebo group. The open-label extension lasted for 32 full weeks, and results from the halfway point were previously reported. The researchers have now presented data from the full 32 weeks at the Alzheimer’s Association International Conference, a major medical conference dedicated to dementia research and treatment.

What have researchers learned from the extension phase?

During the extension phase, some volunteers took the same capsules as used in the main phase. These are the “old” capsules. Other volunteers took new capsules that delivered the expected amount of the study drug – “new” capsules.

Measures of cognition and day-to-day function were repeated at the 16-week time point and at the 32-week time point. Volunteers who were taking the “old” capsules continued to worsen. But for volunteers taking the “new” capsules, the worsening was markedly slowed, suggesting that the study drug is effective at slowing cognitive and functional decline when delivered at the intended dose level.

In addition, the study team measured the levels of an important protein in the brain called glial fibrillary acidic protein, which is often considered an indicator that brain cells are undergoing degeneration. In volunteers taking the new capsules, GFAP levels fell during the extension phase, suggesting that treatment with the study drug may slow decline by reducing degeneration of brain cells.

What is next for this neflamapimod as a potential treatment for DLB?

While these results look promising, they are from a Phase 2 trial. The drug will need to be tested in larger, Phase 3 clinical trials before it can be considered for approval.

How can I get involved?

Finding safe and effective treatments for Lewy body dementia takes research, and research takes people like you.

For more information on clinical trials and other studies that might be right for you, LBDA encourages you to visit our clinical trials page. To stay up-to-date on new studies when they launch, you can also sign up for LBDA’s Lewy Trial Tracker.

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Scientists have been studying a kind of cough medicine called ambroxol to determine if it might be a promising treatment for Parkinson’s disease dementia (PDD), one of the two major forms of Lewy body dementia (LBD). This might seem unusual at first, but the reason researchers are interested in this drug is based on a clue from genetics. People with certain variants of the GBA1 gene are known to be at increased risk for PDD. This gene codes for a protein called GCase, and ambroxol interacts with GCase in a way that researchers believe may be beneficial in slowing disease progression.

A group of Canadian researchers has now reported the results of a small clinical trial of ambroxol in people with mild to moderate PDD.

How was the study designed?

The study enrolled a total of 55 people. These volunteers were randomly assigned to receive either a low or high dose of ambroxol or a placebo for 1 year. During the trial, volunteers completed 11 clinic visits, and researchers checked for safety as well as measuring cognition, movement, neuropsychiatric features, and fluctuations. The volunteers also gave samples of blood and cerebrospinal fluid so that scientists could perform laboratory tests.

What did the study show?

The good news is that the study showed that the drug was safe. Overall, the study suggests that the main side effect was mild to moderate stomach upset.

However, the results did not provide clear evidence of benefit. In comparing the groups of volunteers who took ambroxol and those who took placebo, the differences were small enough that it cannot be ruled out that they occurred by random chance rather than reflecting a true effect of the drug. This is common in small studies such as this one and does not necessarily mean that the drug is ineffective, just that we can’t know for sure until larger studies are completed.

Given the relationship of ambroxol to the GCase protein, the scientists paid special attention to a small handful of volunteers in the study who turned out to have risk variants in their GBA1 genes. Intriguingly, three of them showed improvements in cognition and three of them showed improvements in neuropsychiatric symptoms. Unfortunately, the sample size for these variant carriers was too small to say for certain that this is a real effect.

The researchers also found an intriguing result in a laboratory blood test for the protein GFAP, which is a marker of neurodegeneration, that is, loss of brain cells. Among volunteers in the placebo group GFAP levels increased during year-long trial, but they remained stable in volunteers taking ambroxol. Moreover, this group difference was large enough that the researchers are confident that it represents a true drug effect and may indicate that ambroxol could be protective against neurodegeneration.

What’s next?

This small trial suggests that ambroxol is safe for people with PDD but did not provide clear evidence of benefit. However, results from the volunteers with risk variants in GBA1 are intriguing, particularly given that ambroxol interacts with the protein encoded by GBA1. The effect of the drug on the marker of neurodegeneration, GFAP, is also promising.  A reasonable next step would be to perform another trial, either with a larger sample size or perhaps focused on people with GBA1 gene variants.

In addition, ambroxol is still being studied in clinical trials for Parkinson’s disease and LBD in the UK, Norway, and Australia, and the results from those studies may shed further light.

How can I get involved?

Finding safe and effective treatments for Lewy body dementia takes research, and research takes people like you.

For more information on clinical trials and other studies that might be right for you, LBDA encourages you to visit our clinical trials page. To stay up-to-date on new studies when they launch, you can also sign up for LBDA’s Lewy Trial Tracker.

REFERENCE

Carolina R. A. Silveira CRA, Coleman KKL, Borron K, et al. 2025. Ambroxol as a treatment for Parkinson disease dementia: A randomized clinical trial. JAMA Neurology, online ahead of print. DOI: 10.1001/jamaneurol.2025.1687.

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Is there a connection between bacteria in the mouth and gut and the development of dementia in Parkinson’s disease? New research may shed light.

Cognitive decline and dementia are part of Parkinson’s disease for most people. When a person develops dementia in the context of existing Parkinson’s disease, that is called Parkinson’s disease dementia (PDD), one of the two major forms of Lewy body dementia (LBD), the other being dementia with Lewy bodies (DLB). But what biological factors contribute to the appearance of dementia in a person with Parkinson’s disease? There are likely many, and some recent research suggests that the bacteria and other microorganisms that live in the mouth and gut—collectively called the oral and gut microbiome—may play an important role.

What was this study about?

While not yet well understood, the microbiome has drawn the attention of the research community due to the extraordinarily high number of microorganisms that live in and on our bodies, and the recognition that they affect our health profoundly – in both positive and negative ways. Moreover, the functioning of the gut is compromised in Parkinson’s disease, suggesting that the microbiome may have a special role in Parkinson’s. Given that other studies have linked the appearance and progress of dementia with changes in the microbiome, the researchers wanted to understand how the microbiome in the mouth and gut may differ between people without Parkinson’s (called “healthy controls”), people with Parkinson’s and mild cognitive impairment (PD-MCI) and people with PDD.

What did the researchers do?

The researchers worked with over 100 research volunteers – 26 healthy controls, 41 people with PD-MCI, and 47 people with PDD. Volunteers gave samples of their saliva and stool. The research team then analyzed the saliva and stool samples to learn about the bacteria present in the volunteers’ mouths and guts, respectively.

The researchers studied the DNA found in these samples to identify which bacteria were present in the saliva and stool samples and analyzed the results with both traditional techniques and AI.

What were the findings?

The key finding was that bacteria usually found in the mouth are commonly found in the guts of people with PD-MCI and PDD. This suggests that the movement of oral bacteria to the gut becomes more common as people with Parkinson’s disease develop cognitive decline and dementia. It is not yet clear if these changes are a result of the development of cognitive impairment, a contributor to the development of cognitive impairment, or if both bacteria and cognitive impairment are driven by another, as yet unknown, factor. However, the findings are consistent with a potential causative role of the movement of bacteria from the mouth to the gut.

Furthermore, the researchers found that some bacteria were more common in PD-MCI and others were more common only in PDD. This suggests that the relationship between the presence of these bacteria in the gut and cognitive decline is complex and changes over time. It also hints that someday doctors may be able to use bacterial measures to identify people with Parkinson’s who are at high risk for developing dementia. Moreover, these data may point toward potential therapeutic strategies aimed at controlling bacteria in the mouth and gut.

Will this change prevention strategies or medical treatment?

Not yet, but possibly in the future. This study adds to a growing body of research into the link between the microbiome and brain diseases such as LBD. However, this connection is still poorly understood, and much more research needs to be done before scientists and doctors can be confident in the strength and interpretation of the data. It is possible that modifying the microbiome could be a path toward preventing or treating dementia in Parkinson’s disease, but clinical trials would need to be designed and carried out to know that any therapeutic approach suggested by these results would be safe and effective.

How can I get involved?

Progress against LBD depends on research, and research depends on volunteer participants. If you or someone you know is would like to learn more about research studies that are currently seeking volunteers, you can visit the LBDA clinical studies page.

If you would like to be notified by email when new studies become available, please consider signing up for the Lewy Trial Tracker.

Reference:

Clasen F., Yildirim S, Arikan M, et al. 2025. Microbiome signatures of virulence in the oral-gut-brain axis influence Parkinson’s disease and cognitive decline pathophysiology. Gut Microbes, 17. DOI: https://doi.org/10.1080/19490976.2025.2506843

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Lewy Body dementia (LBD) includes Parkinson’s disease dementia (PDD) and dementia with Lewy bodies (DLB). As the disease progresses, people with LBD need assistance that is not readily available. This often leads to family members stepping in and becoming primary caregivers around the clock for their loved ones with LBD. Research in both Alzheimer’s Disease and LBD has shown that being a family caregiver can lead to significant strain. Researchers at Rush University Medical Center in Chicago, with funding from the National Institutes of Health/National Institute on Aging, are currently testing an education-focused, peer-mentoring intervention that you may be eligible to join if you are an LBD caregiver. All participation is virtual, and the study team is looking for volunteers from all around the US.

Why study LBD caregivers?

LBD is the second most common form of neurodegenerative dementia, affecting 1.4 million Americans. Because LBD progresses across multiple motor, cognitive and psychiatric domains, it’s often unpredictable and leads to higher caregiver strain and comorbidities in comparison to other diseases, such as Alzheimer’s. While the situation can feel dire, research in other conditions has shown the benefits of peer mentoring as an effective way to support family caregivers. Peer mentoring involves pairing a more experienced caregiver with someone who is newer to the caring role for a person with the same condition.

What is being done?

At Rush University, movement disorders neurologist Dr. Jori Fleisher and her team previously found that Parkinson’s Disease and LBD-specific peer mentoring interventions had beneficial effects on caregivers’ knowledge and attitudes—two key contributors to caregiver strain. When mentoring was paired with an LBD-specific curriculum, caregiver confidence, attitudes, depression and LBD knowledge also improved. These findings give us hope that help is out there, in the wisdom of current and former caregivers. Partnering with former caregivers, the curriculum has been designed and revised by dozens of LBD caregivers. The study team then expanded the resources included and made the intervention virtual for the PERSEVERE study, so volunteers can participate from anywhere.

The PERSEVERE study is a fully virtual study designed to test whether providing LBD-specific resources and peer mentoring support improves not only the outcomes for the family caregiver, but whether the knowledge, skills, and confidence gained by the caregivers translates into improved outcomes for their person living with LBD. PERSEVERE covers topics from motor to cognitive symptoms and self-care to care planning. All participants receive 12 weeks of LBD specific resources and are asked to complete surveys for a 9-month period. Participants whose person living with LBD has had cognitive changes for more than three years, or has passed, will be trained to serve as peer mentors. Participants whose person living with LBD has had cognitive changes for less than three years will be randomized 1:1 to an education or mentee group. Mentees and mentors will be asked to call each other once a week during the 12-week curriculum.

During this study, participants will answer questions about their LBD knowledge, strain, quality of life, support system, and the quality of life of their person living with LBD. This data will help gain insight into the challenges caregivers are facing and what can be done to help.

What has the study team learned so far?

The PERSEVERE study is still enrolling participants. So far, baseline data from 196 participants, whose PLBD had cognitive symptoms for less than three years at the time of enrollment, have been analyzed. (Baseline data means data from the first virtual study visit.)

From that group, caregiver strain was found to be correlated with loneliness, caregiver sleep efficiency and duration, and overall sleep quality. Overall sleep quality was also correlated with dementia severity and dependency when completing activities of daily living. Caregiver loneliness was elevated and was associated with younger age and female gender. Loneliness was also inversely associated with social support and positively associated with depression. In other words, the younger a caregiver is, the fewer social supports available, or the more depressive symptoms they have, the more likely they are to be lonely. Additionally, female caregivers were lonelier than their male counterparts.

What do the findings this mean?

Initial data shows many factors are associated with the strain of LBD caregivers. Of those factors, caregiver sleep quality is associated with conditions of the person living with LBD, and loneliness was associated with caregiver demographics, social support and depression. These findings are consistent with the notion that peer mentoring interventions may improve caregiver strain. Once the first cohort of participants has finished the study, data can be analyzed to determine if the education or mentoring support had an impact on these baseline findings. Data will need to be collected from many more participants to verify the impact of the LBD education and peer mentoring support provided as part of the PERSEVERE study.

How can I get involved?

To learn more about the PERSEVERE Study, view the LBDA PERSEVERE page. Alternatively, you can visit https://redcap.link/PERSEVERE1 to watch a video by Dr. Fleisher, testimonials from former participants, and complete a survey to see if you may be eligible. If you have specific questions about the study, please email persevere@rush.edu.

Reference

Fleisher JE, Suresh M, Levin ME, Hess SP, Akram F, Dodson D, Tosin M, Stebbins GT, Woo K, Ouyang B, Chodosh J. 2023. Learning to PERSEVERE: A pilot study of peer mentor support and caregiver education in Lewy body dementia. Parkinsonism Relat Disord. doi: 10.1016/j.parkreldis.2023.105492.

The post Testing a Caregiver Intervention: Initial Findings from the PERSEVERE Study appeared first on Lewy Body Dementia Association.

Earlier this month, CervoMed Pharmaceuticals reported data from an open-label extension phase of the RewinD-LB trial suggesting that the study drug, neflamapimod, may slow cognitive decline in dementia with Lewy bodies (DLB).

What was the RewinD-LB trial?

RewinD-LB was a Phase 2b trial of the experimental drug neflamapimod in people with DLB. A prior Phase 2a trial showed benefit on cognitive decline, particularly for people without evidence of co-existing Alzheimer’s disease (AD). The RewinD-LB trial sought to replicate the findings of the earlier trial, but focused only on people with DLB and no evidence of AD.

In the main phase of RewinD-LB, researchers did not find the same kinds of positive results as they did in the original trial. However, the researchers learned that the drug capsules used in the main phase of the trial were not delivering the same level of drug as they did in the prior Phase 2a trial, possibly explaining the discrepancy in findings.

After the main phase of RewinD-LB, all participants were offered a chance to take the study drug in a phase of the trial called an open-label extension. In the extension phase, all volunteers take active drug; there is no placebo group. The open-label extension is scheduled to last for 32 weeks, and the researchers are now reporting results from the halfway point – 16 weeks.

What are we learning from the extension phase?

During the first 16 weeks of the extension phase, some volunteers took the same capsules as used in the main phase. These are the “old” capsules. Other volunteers took new capsules that delivered the expected amount of the study drug – “new” capsules.

Measures of cognition were repeated at the 16-week time point. Volunteers who were taking the “old” capsules continued to worsen. But for volunteers taking the “new” capsules, the worsening was markedly slowed, suggesting that the study drug is effective at slowing cognitive and functional decline when delivered at the intended dose level. When measuring from the beginning of the main phase of the study, volunteers taking “old” capsules had a worsening of approximately 1.5 points on the Clinical Dementia Rating Scale – Sum of the Boxes (CDR-SB) through the first 16 weeks of the extension phase, whereas volunteers taking the “new” capsules declined by only approximately 0.7 points.

What is next for this study?

While the results through the halfway point of the extension phase look quite promising, the full extension will last 32 weeks, and all volunteers have now been switched to the “new” capsules for the remainder of the extension. At the end of the 32 weeks, cognitive and functional measures will be repeated. In addition, biomarker testing will be repeated at the end of the extension phase (it was not done at the 16-week point).

Scientists are eagerly awaiting the results of the full extension phase; the additional data will help to place the current results in context.

LBDA looks forward to bringing you the full results as soon as they are made public by the study team.

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