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Saturday, December 6, 2025

'Walz faces political jeopardy over Minnesota fraud controversy'

 Minnesota Gov. Tim Walz (D) is facing a challenging political future as he finds himself at the epicenter of a growing fraud scandal in his home state. 

The controversy, which focuses on hundreds of millions of dollars allegedly stolen from a federally funded nutrition program, has led to more than 50 convictions. The New York Times gave the story national attention last week, highlighting statements from federal prosecutors that as much as $1 billion in taxpayer money may have been stolen in separate plots.

It has even Walz’s longtime allies wondering if the governor should walk away from a reelection bid for a third term as governor. 

“The governor, I think, has done a very respectable job, a good job, in Minnesota for the years that he’s been here. But he clearly is vulnerable and in my view, he is riskier than any Democratic candidate that might run,” said Ember Reichgott Junge, a former Minnesota Democratic state senator and a political analyst in the state.

Reichgott Junge said fraud “happened on his watch” and that Walz “can’t erase that.” While she said the governor is taking steps to rectify it, including audits, those investigations will “probably uncover more.”

“So this issue is going to continue to surface through the next year,” Reichgott Junge added, saying it’s a “significant issue” in the state and noting it is “in the headlines virtually every other day.”

A second longtime ally of Walz’s in the state told The Hill that the controversy is “obviously not great” for the governor and calls into question not only his gubernatorial reelection for a third term but a possible presidential bid. 

“The challenges are that Minnesota has a very low tolerance for fraud, waste and abuse. It’s a very low threshold, and that’s one of the reasons the state has worked so well for so long,” the ally said. “It’s clearly a real vulnerability.”

The ally noted polling that shows Walz’s disapproval ratings rising in the state. A Minnesota Star Tribune poll out this summer showed that Walz had a 49 percent disapproval rating and that it had climbed almost 7 points since a similar poll was taken in 2022. 

“Even suburban dads would bring it up to me over the summer,” the ally said.

It was only 16 months ago when Walz, 61, vaulted onto the national political scene as then-Vice President Kamala Harris’s running mate.

Walz first emerged as a dark horse contender for the No. 2 slot and ended up winning the position over other prospects such as Pennsylvania Gov. Josh Shapiro (D) and Arizona Sen. Mark Kelly (D). He saw his profile jump in the weeks ahead of Aug. 6, 2024, when Harris made the call — and particularly after a viral cable news interview in which he derided some Republicans as “weird.”

Walz’s star faded somewhat after Harris’s loss to President Trump. The Harris-Walz ticket only won the state of Minnesota by 4 percentage points, and it lost Shapiro’s swing state of Pennsylvania, in addition to Wisconsin and Michigan.

“I think we all had high hopes for him, but I don’t think he was a very effective running mate at the end of the day,” one top Democratic strategist said. “It never seemed like he was comfortable in the role beyond his rollout.” 

The Minnesota governor at the beginning of this year was still seen as a potential future Democratic presidential contender, however, and he and Trump have regularly sparred with one another.

Trump over the last week has brought up the Somali controversy and signaled an interest in increasing his deportation efforts in the state by focusing on Somali immigrants.

The president has also come under criticism himself over his remarks about Somali immigrants.

During a Cabinet meeting Tuesday, Trump said he did not want immigrants from Somalia to stay in the U.S.

“We can go one way or the other, and we’re going to go the wrong way if we keep taking in garbage into our country,” Trump said in comments that also targeted Rep. Ilhan Omar (D-Minn.), who came to the United States from Somalia. 

A day later, the president said that “Somalians should be out of here. They’ve destroyed our country” and said that Minnesota had become a “hellhole” as a result. 

Walz, seeking to go on offense, fired back at Trump, saying Thursday that it was “unprecedented” for a United States president to make that kind of attack. “We’ve got little children going to school today who their president called them garbage.” 

Reached by The Hill on Friday, the governor’s office pointed to the work Walz’s team is doing to combat fraud. 

That work includes ordering a third party audit of Medicaid billing at the Department of Human Services, creating a centralized fraud investigations unit at the Minnesota Bureau of Criminal Apprehension as well as funding additional auditors and internal control specialists.

The governor’s office is also securing new statutorily mandated requirements for high-risk Medicaid programs including expanded background checks on providers and enhanced financial transparency disclosures and more frequent site visits. 

A source close to Walz’s reelection campaign added that “Minnesotans understand that Trump is using this issue to unfairly attack Gov. Walz.”

“Trump has overplayed his hand and Minnesotans aren’t going to go for it,” the source said. 

Allies say Trump’s comments will ultimately help Walz, but Republicans are looking to go on the attack. More than a dozen GOP candidates have entered the gubernatorial race to oppose him. 

“Our election will be decided by the purple Minnesotans, if you will, and everyone is paying attention to this,” said Annette Meeks, a longtime Republican activist. “Everyone is paying attention to this.”

“To use one of my favorite Bush words, he’s bigly damaged,” Meeks said, referring to former President George W. Bush. 

Still, she added, “I don’t think it’s a fatal blow.”  

Democratic strategist Eddie Vale said it’s also too soon to tell what impact the scandal has on Walz. 

“I think it’s very much an open question of if the laws of political gravity return or have been permanently altered by Trump,” Vale said. “In the past it certainly would be something they need to deal with but as Trump is tearing down parts of the White House funded with corporate bribes and backing truckloads of crypto into his family’s accounts it’s going to be much harder to make things like this stick.” 

A KTSP/Survey USA poll out in September showed that those who participated were evenly split on Walz: 47 percent approved of his performance as governor, and 47 percent disapproved. Six percent said they had no opinion. 

Reichgott Junge said Walz’s problem is that many Minnesota voters will likely see the controversy over the fraud as landing on his desk.

“The buck stops with the governor, I’m sorry it just does,” Reichgott Junge said, adding that while people don’t blame him directly for the fraud, running for a third term is risky. 

“The governorship is important in Minnesota,” Reichgott Junge said. “It’s our only stopgap really between the Trump administration and a divided legislature. So if we lose the governorship then we lose a lot. 

“And who knows what could happen if we lost that governorship."

https://thehill.com/homenews/state-watch/5635849-walz-political-future-fraud-scandal/

Newsom Pleads With Dems To Be More "Culturally Normal"

 by Steve Watson via Modernity.news,

California Governor Gavin Newsom is dishing out advice to his fellow Democrats: pretend to be normal while he plots a White House run.

Newsom, who’s been eyeing a 2028 presidential bid after loser Kamala Harris’ electoral wipeout, took to the stage at The New York Times DealBook Summit in New York City, urging his party to ditch the judgmental elitism that’s alienated everyday Americans.

“I think there’s a broader narrative that [Democrats] ought to address, that is, we have to be more culturally normal,” Newsom said, adding “We have to be a little less judgmental.”

He went on to stress the need for Democrats to grasp “the importance and power of the border, substantively and politically,” acknowledging how open borders and lax enforcement have fueled voter backlash.

In the same breath, Newsom unleashed on Fox News, comparing it to Soviet-era propaganda, saying “You got Pravda, the primetime lineup at Fox, just going on and on [in defense of Trump].”

He then slammed Trump as a “man-child,” declaring that the the President “called someone the ‘R word’ or piggy, and somehow it’s just ‘Trump being Trump.’ Nothing normal about this… It’s unbecoming to the president of the United States.”

Newsom then explained his own Trump-mimicking social media account antics were “approved” by him to “wake everybody up” to the “normalization of deviancy.” He accused Fox of criticizing his posts but never uttering a “damn word” about Trump’s rants.

The comments come as Newsom warns that Trump is “trying to wreck this country,” a claim that rings hollow given California’s ongoing crises under his watch, from rampant homelessness and crime to devastating wildfires that have scorched communities like the Pacific Palisades.

A Berkeley poll earlier this year found 54% of registered voters believe Newsom prioritizes his presidential ambitions over fixing the state’s problems, with only 26% saying he’s focused on governance.

X users mocked Newsom’s call for Democrats to feign “normalcy,” highlighting the irony of a governor whose policies have driven businesses and residents out of California in droves.

This isn’t the first time Newsom’s slimy posturing has drawn fire. Florida Rep. Anna Paulina Luna recently blasted the governor for his online antics during an appearance on the PBD Podcast.

Host Patrick Bet-David noted, “You’re either a great troll or you’re trying to be. Like Newsom is dying to be Trump, but he’s not. Newsom is trying to be Trump. Newsom’s not Trump, right? Nowhere near him. But everything he does, he’s trying to be — the Trump of the left.”

Luna recounted a joke she made on a Comedy Central show: “I was on a show recently. I think it was on Comedy Central, it was like an evening talk show. And they’re talking about the ‘No Kings’ protests and I made a joke and I was like, ‘Well if you’re talking about Gavin Newsom it would be the ‘No Queens’ protest.’”

When asked if it was homophobic, she replied, “No he [Newsom] just has feminine tendencies, and it’s totally true. I don’t know, like — he bitches on the internet all the time. It’s like what are you doing, Gavin? You know, you have fires in the Palisades — what’s going on?”

Bet-David agreed, calling Newsom’s vibe “metro.”

Adding fuel to the fire, actress Halle Berry stunned the DealBook crowd earlier that day by slamming Newsom for vetoing a menopause care bill twice, questioning his fitness for higher office.

“Back in my great state of California, my very own governor, Gavin Newsom, has vetoed our menopause bill, not one, but 2 years in a row! But that’s OK, because he’s not GOING to be governor forever!” Berry urged.

She continued, “With the way he’s overlooked women, half the population, by devaluing us in midlife, he probably should not be our next president either! Just saying!”

Berry rallied the audience, stressing “I need every woman in this country to fight with me. But the truth is, the fight isn’t just for us women. We need men too. We need all of the leaders, every single one of you in this room. This fight needs you.”

The Menopause Care Equity Act aimed to boost research and education on women’s health, but Newsom vetoed it citing potential cost hikes for working women. Berry’s raw callout drew gasps, underscoring how even Hollywood elites are turning on him amid whispers of his 2028 aspirations.

Newsom’s “normalcy” sermon exposes the Democrats’ desperation after years of pushing radical agendas on gender ideology, unchecked immigration, and climate hysteria that have alienated the heartland. 

If this is their comeback strategy—masking extremism while California burns—good luck selling that to voters who’ve had enough of the chaos. Trump’s policies are winning because they’re grounded in reality, not performative tweaks.

https://www.zerohedge.com/political/newsom-pleads-dems-be-more-culturally-normal

Beyond Early Detection—Reframing Radiology’s Role in Lung Cancer Care

 a,b ∙ c aprosper@mednet.ucla.edu ∙ d

Introduction

Lung cancer has long stood as the most formidable cancer killer, burdened not only by late-stage diagnoses but also by decades of stigma and fatalism. Today, however, the landscape is shifting. Advances in screening, therapeutics, and survivorship have created a new reality; lung cancer is treatable, survivable, and increasingly understood as a chronic disease for many. The accompanying editorial from the American Cancer Society National Lung Cancer Roundtable [] chronicles this progress and the collaborations that have fueled it. This issue of the Journal of the American College of Radiology builds on that foundation, challenging radiology to expand its role from early detection to system transformation.

Radiology as a Catalyst for Integration

The articles in this issue collectively underscore that radiology is no longer a siloed specialty. Instead, radiology functions as a hub, integrating screening into existing cancer pathways, coordinating care across disciplines, and linking patients to prevention, diagnostics, and treatment. Radiology departments are now touchpoints for tobacco cessation, gateways for biomarker testing, and connectors to survivorship resources. This evolution demands that radiology practices not only interpret images but also develop collaborations to design interdisciplinary systems that reduce fragmentation and improve continuity of care.

Shifting From Volume to Value

A crosscutting theme reflected in these contributions is the move from counting scans to measuring impact. Lung cancer screening is not merely about increasing uptake; it is about ensuring that those who are screened are reached equitably, managed appropriately, and supported holistically. The science of lung cancer screening effectiveness is well established, but its value will be determined by how well programs close gaps for rural patients, underserved populations, and communities historically marginalized by health care. For radiology, this means embedding equity into workflow, reimbursement advocacy, and quality improvement, not as add-ons, but as core metrics of success. In addition, measurement of screening outcomes including adherence, radiation dose, and potential harms remains critical for understanding the net benefit of LCS for high-risk individuals.

Confronting the Human Dimensions of Screening

Perhaps most importantly, the work highlighted here reminds us that lung cancer screening is not simply a technical procedure, it is an emotional and social experience. Patients bring fear, uncertainty, and lived histories of stigma into the radiology suite. Anxiety about scans and results, compounded by stigma tied to smoking, can undermine trust and adherence. Radiology practices have the opportunity to counter these forces by designing environments that prioritize empathy, clarity, and respect. Small but intentional changes in how results are communicated, how patients are greeted, and how teams are trained can profoundly shape patient experience, facilitating ongoing screening participation over time that is essential to the early detection of lung cancer.

The Imperative of Innovation and Implementation

From predictive analytics and artificial intelligence-enabled surveillance to pragmatic trials of surveillance intensity, this issue also illustrates how innovation must go hand in hand with implementation. New tools and technologies will not matter if they are not deployed in ways that are usable, affordable, and aligned with patient needs. The future of lung cancer-related screening lies not only in refining imaging technology but also in embedding those advances into sustainable, patient-centered systems that work across varied practice settings—from academic centers to rural clinics.

The Articles

The first set of articles realistically assesses our ability to identify either individuals eligible for screening due to smoking exposure or individuals with environmental exposures associated with lung cancer []. The next set of articles explores leveraging the higher adherence mammography screening to increase lung cancer screening []. The next group of articles describes community-based interventions to increase lung screening as well as how state-level policy can support increased screening and diagnosis [].
Lung cancer screening is not entirely benign. We provide a series of articles discussing the harms of screening including “scanxiety” and managing radiation dose [].
The final set of articles deals with some of the remaining issues in screening such as system operability, difficulties in collaboration across the specialties in rural practices, and cannabis use among those undergoing lung screening [].

A Moment of Responsibility

Together, the articles in this issue paint a clear picture: lung cancer screening has matured from a research intervention into a public health imperative. The question is no longer whether lung cancer screening saves lives—it does—but how we ensure that its benefits are realized broadly, equitably, and with dignity. Radiology is uniquely positioned to lead this charge.
The challenge before us is to transform lung cancer care from one defined by stigma and loss to one characterized by survivorship and hope. Doing so requires radiology to embrace its expanded role—not just as detectors of disease, but as architects of systems, stewards of equity, and champions of patient dignity. The work captured in this special issue shows that the path forward is not only possible but already under way.

Gene Therapy Also Effective in Younger Children With Inherited Blood Disorders

 The gene therapy exagamglogene autotemcel (exa-cel; Casgevy) -- already approved for patients 12 years and older with transfusion-dependent beta-thalassemia (TDT) and sickle cell disease (SCD) -- led to durable clinical benefits in kids ages 5 to 11 years, two phase III trials showed.

Among the evaluable children with TDT in the CLIMB THAL-141 study, all six achieved transfusion independence for 12 or more consecutive months, with a mean transfusion-free duration of 19.8 months (range 14.0-22.5 months), reported Haydar Frangoul, MD, of the Sarah Cannon Research Institute and TriStar Centennial Children's Hospital in Nashville, Tennessee, during a press briefing in advance of the American Society of Hematology annual meeting.

Twelve of the 13 children included in the study stopped red blood cell (RBC) transfusions at a mean of 1.3 months after exa-cel treatment, with the duration of transfusion independence ranging from 2.3 to 22.5 months.

In the CLIMB SCD-151 study, all four evaluable children with SCD were able to go 12 or more consecutive months without experiencing severe vaso-occlusive crises (VOCs) or being hospitalized for severe VOCs.

None of the 11 participants in the SCD study had a VOC after exa-cel infusion, with VOC-free duration ranging from 3.2 to 24.1 months.

"Pediatric and adolescent participants have fewer VOC events after exa-cel than adult participants, consistent with treatment prior to the onset of chronic organ damage, including chronic pain," Frangoul said.

The efficacy of exa-cel was the same in patients ages 5 to 11 years compared with those ages 12 to 17 years, he noted, adding that exa-cel "has the potential to provide a one-time functional cure for children aged 5-11 years with TDT or sickle cell disease."

Exa-cel is the first FDA-approved therapy utilizing CRISPR/Cas9, a type of gene editing technology through which patients' hematopoietic stem cells are modified. It was approved for patients ages 12 and older with SCD in December 2023, and for the same age group with TDT in January 2024.

Frangoul noted that data from the CLIMB THAL-111 and CLIMB SCD-121 trials among patients ages 12 to 17 showed reactivation of the synthesis of hemoglobin F to levels that "are known to eliminate the need for transfusion in patients with TDT, and VOCs in sickle cell disease." He and his colleagues hypothesized that based on exa-cel's mechanism of action, efficacy was expected to be similar across all ages.

CLIMB THAL-141 included patients ages 2 to 11 years with TDT. Mean age at the time of screening was 7.4 years, 12 of the 13 children had an intact spleen, and the median annualized volume of historical packed RBC transfusions was 232.3 mL/kg.

CLIMB SCD-151 included SCD patients ages 2 to 11 with a history of two or more severe VOCs per year for the previous 2 years before enrollment, as well as hydroxyurea failure unless hydroxyurea intolerant. Mean age was 8.5 years, median number of severe VOCs per year was three, and median number of hospitalizations for severe VOCs per year was two.

In both studies, exa-cel was administered by intravenous infusion following myeloablative conditioning with busulfan.

Exa-cel's safety profile was "consistent with what we would expect with high-dose busulfan conditioning and autologous stem cell transplant," Frangoul said, adding that it was similar to what was observed in patients ages 12 to 35 in the CLIMB THAL-111 and CLIMB SCD-121 studies.

Frangoul reported that one patient in CLIMB THAL-141 died from pneumonia in the setting of multi-organ failure due to severe vaso-occlusive disease related to busulfan. Fatal veno-occlusive disease is a known risk of busulfan therapy that is known to occur at a higher frequency in children compared with adults, he said.

Disclosures

The CLIMB trials were sponsored by Vertex Pharmaceuticals.

Frangoul reported relationships with Jazz Pharmaceuticals, BioLine, Vertex Pharmaceuticals, Rocket Pharma, and Editas Medicine.

Nerve Stimulation for Epilepsy: Intracranial Versus Extracranial

 Are neurostimulators implanted within the brain a better approach in epilepsy than less-invasive vagus nerve stimulation (VNS)? That depends, a researcher said.

Real-world data from two large electronic health records databases showed that short-term complications were vastly greater with deep brain stimulation (DBS) or responsive nerve stimulation (RNS), both of which involve threading wires into the brain, according to Samhitha Rai, BS, an MD candidate at Case Western Reserve University and the Cleveland Clinic in Ohio.

But long-term mortality -- which her group considered a proxy for seizure control -- became substantially worse for patients treated with VNS compared with the intracranial implants, starting at about 5 years after surgery, Rai reported at the American Epilepsy Society (AES) annual meeting.

"This study, the largest of its kind to date, provides powerful, replicated real-world evidence to guide individualized, shared decision-making for patients with drug-resistant epilepsy," she said.

Based on the findings, Rai characterized RNS/DBS as "high-risk, high-reward" alternatives to VNS, which has been around much longer and has traditionally been the most popular type of neurostimulation therapy for seizure disorders.

VNS involves placing a pulse generator, generally in the chest or back, with leads running to the vagus nerve in the neck. RNS and DBS differ from each other considerably, but in both cases, the implanted device has leads extending into the brain, and thus require much more invasive surgical procedures.

RNS and DBS now have a substantial evidence base as well, but as Rai noted, no rigorous head-to-head trials have compared them, and none are anticipated. Thus, her group pulled data from the massive Epic Cosmos and TriNetX records storehouses to see how they have stacked up in routine care.

Epic Cosmos holds records for some 300 million individuals in the U.S., while TriNetX covers about half that many in the U.S. and 22 other countries. Among them were about 4.2 million in Epic Cosmos and 1.9 million in TriNetX with diagnoses of epilepsy; 21,375 in the former and 13,860 in the latter had received neurostimulation implants. Patients whose records indicated a Parkinson's disease diagnosis, another condition treated with neurostimulation, were excluded. The researchers also went further, using propensity matching to create cohorts within each database of clinically similar patients treated with the two categories of procedures. In Epic Cosmos there were 5,618 in each group, and in TriNetX there were 2,917.

Serious short-term complications were substantially more common with RNS and DBS. This was most notable for hemorrhagic stroke, which occurred within 3 months in 4% of patients in both databases treated with the brain implants, versus 0.2-0.4% of VNS recipients. Ischemic strokes within 3 months in the Epic Cosmos cohorts were seen in 2.7% with RNS/DBS, compared with 2.0% for VNS; in TriNetX, the corresponding rates were 1.4% and 0.6%, respectively. All of these differences were "highly statistically significant," Rai said.

Another proxy for seizure control was emergency department visits, and this analysis, which covered visits over the 5 years after surgery, favored the more invasive procedures. RNS/DBS were associated with rates of 32% in TriNetX and 49% in Epic Cosmos, versus 41% and 58%, respectively, with VNS.

Overall mortality, meanwhile, was almost identical between procedures through year 5, at which point about 94% of patients were still living, but the tracks then began to diverge. By year 8, the differences were statistically significant: survival was about 91% in the RNS/DBS group compared with 88% for patients receiving VNS. Among patients with 13 years of follow-up, the gap was far wider: 86% versus 76%.

Study limitations included the reliance on administrative data. Also, the propensity matching was made for sex, age, ethnicity, race, comorbidities, smoking, BMI, anti-seizure medications, MRI abnormalities, and epilepsy etiology, but that still left considerable room for unmeasured confounders. And an AES attendee pointed out that RNS and DBS are very different procedures and by lumping them together, it was unclear whether the findings were driven primarily by one or the other.

Disclosures

CervoMed Neflamapimod Shows Promise in Dementia With Lewy Bodies

 New data from a phase IIb trial extension study suggested that investigational neflamapimod led to significant improvements on key outcomes in people with dementia with Lewy bodies (DLB).

In the RewinD-LB extension study, neflamapimod reduced plasma glial fibrillary acidic protein (GFAP) levels, which correlated with improved Clinical Dementia Rating-Sum of Boxes (CDR-SB) scores in DLB patients, reported John-Paul Taylor, MBBS, of Newcastle University in England, at the Clinical Trials on Alzheimer's Disease annual meeting.

In topline data released in 2024, neflamapimod did not demonstrate significant effects versus placebo in RewinD-LB. An initial analysis suggested that target plasma drug concentrations were not reached during the double-blind phase of the trial.

The extension phase of RewinD-LB tested a second batch of neflamapimod capsules (Batch B) after it was determined that participants in the double-blind phase did not achieve expected drug concentration levels with Batch A, likely because the capsules were too old, Taylor noted. In the extension phase, Batch A served as a control arm.

In the initial 16-week double-blind period, there was no significant difference in plasma GFAP between neflamapimod (Batch A) and placebo.

At week 16 of the extension phase, participants who received Batch B capsules had a significant drop in plasma GFAP (median change -16.0 pg/mL, P<0.0001). This reduction correlated with improvement in CDR-SB scores (r=o.35, P=0.036), Taylor said.

DLB, an alpha-synucleinopathy characterized by widespread cortical and subcortical Lewy bodies, has no approved disease-modifying treatment. It progresses more rapidly than Alzheimer's disease, and Alzheimer's co-pathology is common in up to 50% of DLB patients.

"In early stages, a major driver of disease expression and progression is dysfunction and degeneration of basal forebrain cholinergic neurons," Taylor said.

Neflamapimod is an oral p38 alpha kinase inhibitor that targets dysfunction and degeneration of acetylcholine-producing neurons. The drug is in clinical development to treat DLB, recovery after ischemic stroke, and frontotemporal dementia.

Data from early research supported advancing neflamapimod to a phase IIb study in DLB, Taylor pointed out. In the phase IIa AscenD-LB study, the drug improved CDR-SB scores and reduced GFAP levels compared with placebo.

The phase IIb RewinD-LB trial evaluated DLB patients with a baseline Clinical Dementia Rating global score of 0.5 (very mild dementia) or 1.0 (mild dementia). Participants had a plasma phosphorylated tau 181 (p-tau181) level under 27.2 pg/mL to minimize the risk of Alzheimer's co-pathology.

When RewinD-LB started, 27.2 pg/ml was estimated to be the optimal p-tau181 cutoff for Alzheimer's co-pathology in DLB patients, Taylor noted. Research now supports a more stringent cutoff of 21.0 pg/mL.

RewinD-LB had two parts: a 16-week placebo-controlled phase and a 32-week open-label phase. The first phase randomized 159 DLB patients to 40 mg of oral neflamapimod three times a day or placebo. In the second phase, all participants received 40 mg of oral neflamapimod three times a day.

CDR-SB score changes were 52% lower in patients who received Batch B compared with those who received Batch A, and 82% lower in patients with plasma p-tau181 under 21.0 pg/mL at baseline, Taylor noted.

This indicates a "significant effect on clinical progression when target plasma concentrations were achieved, most prominently in patients with low likelihood of having Alzheimer's disease co-pathology," he said. The clinical effect was durable to 32 weeks of treatment, he added.

Few participants dropped out of the study due to adverse events. During the placebo-controlled phase, 2.5% of neflamapimod recipients discontinued the study due liver enzyme elevations; in the extension phase, 1.3% did. All liver enzyme elevations were reversible, and none were associated with bilirubin elevation. The only adverse event with more than 10% incidence was falls.

Drug developer CervoMed plans to start a phase III trial of 300 DLB patients in the second half of 2026, Taylor said. The study will focus on DLB patients with plasma p-tau 181 levels under 21.0 pg/ml, he added.

Disclosures

The study was funded primarily by the National Institutes on Aging.

Taylor disclosed a relationship with CervoMed. Some co-authors are CervoMed employees.