Author: Rachael Hansford

Accelerated Approval in Huntington’s disease?

Posted on December 12, 2024 by - Huntington's disease, Movement Disorders

uniQure announces alignment with FDA on key elements of Accelerated Approval pathway for AMT-130 in Huntington’s disease

  • U.S Food and Drug Administration (FDA) agrees that data from ongoing Phase I/II studies compared to a natural history external control may serve as the primary basis for a Biologics License Application (BLA) for Accelerated Approval
  • FDA agrees that the composite Unified Huntington’s Disease Rating Scale (cUHDRS) may serve as an intermediate clinical endpoint for Accelerated Approval

10 December 2024: – uniQure N.V., a gene therapy company advancing therapies for patients with severe medical needs, has announced that the company reached agreement with the U.S Food and Drug Administration (FDA) on key elements of an Accelerated Approval pathway for AMT-130.

“We are very pleased to reach agreement with the FDA on core components of an Accelerated Approval pathway for AMT-130,” said M.D., Chief Medical Officer of uniQure. “Our alignment reflects the strength of our data and collaborative discussions with the staff and senior management at FDA’s Center for Biologics Evaluation and Research (CBER). This is an important milestone for the Huntington’s disease community as it puts us on the most rapid and efficient pathway to deliver a potentially life-changing therapy to people living with this devastating neurodegenerative disorder. We have initiated BLA readiness activities and look forward to further engaging with the FDA in the first half of 2025 to discuss our statistical analysis plan and the technical CMC requirements.”

As part of uniQure’s Regenerative Medicine Advanced Therapy (RMAT) Type B meeting held in late November, the FDA agreed that data from the ongoing Phase I/II studies, compared to a natural history external control, may serve as the primary basis for a BLA submission under the Accelerated Approval pathway, avoiding the need for an additional pre-submission study. The FDA also agreed that cUHDRS may be used as an intermediate clinical endpoint and that reductions in neurofilament light chain (NfL) measured in cerebrospinal fluid (CSF) may serve as supportive evidence of therapeutic benefit in the application for accelerated approval.

The FDA granted uniQure RMAT designation for AMT-130 in May 2024, stating that preliminary clinical data from the ongoing Phase I/II studies indicate AMT-130 has the potential to address unmet medical needs for the treatment of Huntington’s disease. In July 2024, uniQure presented interim data at 24 months showing durable, dose-dependent slowing of disease progression based on the cUHDRS of treated patients compared to a propensity-weighted natural history. These data also showed reductions in CSF NfL, a measure of neurodegeneration, in treated patients at 24 months compared to baseline.

About the Phase I/II Clinical Programme of AMT-130
uniQure is conducting two multi-centre, dose-escalating, Phase I/II clinical studies to explore the safety, tolerability, and exploratory efficacy signals of AMT-130 for the treatment of Huntington’s disease. In the U.S. study, a total of 26 patients with early manifest Huntington’s disease were randomised to treatment (n=6 low dose; n=10 high dose) or an imitation (sham) surgical procedure (n=10). Treated patients received a single administration of AMT-130 through MRI-guided, convection-enhanced stereotactic neurosurgical delivery directly into the striatum (caudate and putamen). The study consists of a blinded 12-month core study period followed by unblinded long-term follow-up of treated patients for five years. An additional four control patients crossed over to treatment.

The European open-label Phase Ib/II study of AMT-130 enrolled 13 patients with early manifest Huntington’s disease (n=6 low dose; n=7 high dose). A third cohort is enrolling an additional 12 patients across sites in the U.S. and EU. This cohort is randomised to explore both doses of AMT-130 in combination with immunosuppression, using the current, established stereotactic administration procedure. Additional details are available on http://www.clinicaltrials.gov (NCT0543017, NCT04120493).

AMT-130 was granted the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation, the first for Huntington’s disease.

Vamorolone for Duchenne Muscular Dystrophy

Posted on December 10, 2024 by - Neuromuscular

10 December 2024: The National Institute for Health and Care Excellence (NICE) has approved vamorolone (Agamree, Santhera) as a treatment option for Duchenne Muscular Dystrophy (DMD) in individuals aged 4 years and over, following a revised pricing agreement with the manufacturer. Despite initial rejection in March due to uncertainties in evidence and cost-effectiveness, further analyses and a revised discount secured its approval. This follows MHRA approval in January.

Approximately 1700 individuals in England with DMD could benefit from this new treatment option. Read the full guidance.

Key Benefits of Vamorolone:

  • Alternative to Corticosteroids: Vamorolone serves as an alternative to traditional corticosteroids like prednisone, which are associated with side effects such as osteoporosis and increased fracture risk.
  • Potentially Safer Profile: Vamorolone’s unique structure reduces adverse effects on growth and bone health, making it a potentially safer option, especially for patients transitioning from other corticosteroids.

The approval is supported by data from the VISION-DMD clinical trial, a phase 2b, double-blind study involving 121 children with DMD aged 4-6 years.

Key findings included:

  • Improved time-to-stand velocity over 24 weeks.
  • Minimal impact on height percentile and bone turnover markers compared to prednisone.

Vamorolone could offer important benefits to patients and their families because of its potential to reduce adverse events associated with current steroid treatments

Helen Knight, Director of Medicines Evaluation at NICE

Episodic migraine in children and adolescents

Posted on December 5, 2024 by - Headache

Teva presents positive efficacy and safety data of AJOVY® (fremanezumab) for the prevention of episodic migraine in children and adolescents from Phase 3 SPACE trial

  • AJOVY® (fremanezumab) significantly reduced monthly migraine days (MMD) and monthly headache days (MHD) versus placebo over a 12-week period in paediatric patients aged 6-17 years [1]
  • Efficacy consistent with fremanezumab pivotal Phase 3 and Real-World Evidence studies in adults with no new emergent safety signals observed
  • Full data presented as a late breaker at European Headache Congress (EHC) 4-7 December in Rotterdam, Netherlands

4 December 2024: Teva Pharmaceutical Industries Ltd presented positive data from its Phase 3 SPACE study evaluating the efficacy and safety of AJOVY® (fremanezumab) for the prevention of episodic migraine in children and adolescent patients aged 6-17 years [1]. The trial showed statistically significant superior efficacy compared to placebo over 12 weeks with a favourable safety profile [1] consistent with that observed in the adult population. 

Migraine is common among children, with an overall estimated prevalence of 7.7 [1]. The prevalence increases from 5% among children aged 5 to 10 years-old to approximately 15% among adolescents [2].  Migraine can cause significant disability in children and adolescents, leading to absence from school, impaired educational performance and missed social activities [2].

This is an important milestone for clinicians and young patients living with episodic migraine who currently have little treatment options available to them. This is the first Phase 3 trial of a CGRP-pathway treatment that has shown statistically superior efficacy with favourable safety and tolerability for the prevention of episodic migraine in children and adolescents.”

Professor Patricia Pozo-Rosich, Headache Unit and Research Group, Head of Section Neurology Department at Vall d’Hebron Hospital and Research Institute, Barcelona, one of the lead investigators

SPACE is a multicentre, double-blind study evaluating the efficacy and safety of fremanezumab in 237 children and adolescents with episodic migraine aged 6-17 years. The paediatric study participants had been diagnosed with migraine for 6 months or more, with a history of less than 14 headache days a month. The trial included subgroup analyses by age (6 -11 years and 12 -17 years) and by sex [1].

Highlights from the SPACE data showed that over 3 months fremanezumab achieved: [1]

  • Significant reduction in monthly migraine days (MMD) vs placebo (-2.5 vs -1.4; p=0.0210)
  • Significant reduction in monthly headache days (MHD) vs placebo (-2.6 vs -1.5; p=0.0172)
  • Significantly higher number of children achieving a 50% response rate vs placebo (47.2% vs 27.0%; p=0.0016)
  • Benefits were similar in both the age subgroups and between boys and girls

Fremanezumab also demonstrated a favourable safety profile, and was well tolerated with no safety signals: [1] 

  • Proportion of children reporting ≥1 adverse events (AEs) was similar between the treatment group vs placebo (55% vs 49%)
  • Proportion of patients with serious adverse events (SAEs) and AEs leading to treatment discontinuation was low at ≤3% and ≤1% respectively

“Over the last 30 years, the incidence of childhood migraine has increased but there has been little innovation in licenced treatments to manage this debilitating condition in children.” said Eric A. Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer, Teva Pharmaceuticals. “We’ve already seen the benefits of AJOVYin adultsand the SPACE trial has confirmed that children with episodic migraine can also benefit from AJOVY. This is a significant step forward for the care of migraine in children and adolescents who are having to live with this high burden.”

Teva continues to study the impact of fremanezumab in pediatric patients with chronic migraine and its long-term safety.

References

[1] Hershey, A., et al. Efficacy and Safety of Fremanezumab for the Preventive Treatment of Episodic Migraine in Children and Adolescents: a Phase 3, Randomised, Double-Blind, Placebo-Controlled Study. Presented at European Headache Congress (EHC); 4-7 December 2024, Rotterdam. AL026.

[2] Pediatric Migraine, An Update. Greene, Kaitlin. et al; Neurology clinics, Volume 37, Issue 4, 815-833. August 31, 2019.  https://doi.org/10.1016/j.ncl.2019.07.009

About SPACE

SPACE is a multicentre, randomised, double-blind, placebo-controlled, parallel-group study comparing the efficacy, safety, and tolerability of subcutaneous administration of fremanezumab versus placebo over a 12 week period for the preventive treatment of episodic migraine in 237 paediatric patients aged 6 to 17 years. 

About AJOVY®

AJOVY® is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.

A link between gut bacteria and Alzheimer’s disease?

Posted on December 1, 2024 by - Alzheimer's Disease, Dementia

1 December 2024: A study by researchers at Florida State University’s Gut Biome Lab has revealed a potential link between an infection caused by gut bacteria and the progression of Alzheimer’s disease.

The research found that the bacteria Klebsiella pneumoniae — a common bacteria notorious for causing hospital-acquired infections — can migrate from the gut into the bloodstream and eventually into the brain. This bacterial invasion may lead to increased inflammation in the brain and impair cognitive functions, mimicking symptoms seen in Alzheimer’s patients. The work was published in The Journal of Infectious Diseases.

“Hospitalisations and ICU stays, combined with antibiotic exposure, may lead to a further decline in microbiome diversity that leaves older adults at high risk not only for digestive issues but also for extra-intestinal pathologies such as neurodegenerative disorders through a dysregulation of the gut-brain axis,” said Ravinder Nagpal, an Assistant Professor in the FSU College of Education, Health, and Human Sciences and the Director of the Gut Biome Lab.

The study is the first to show a direct correlation between K. pneumoniae infection and Alzheimer’s pathology, fueling the emerging field that investigates how infectious agents may trigger or aggravate Alzheimer’s disease. It also paves the way for future research into how to treat harmful infectious agents in vulnerable populations such as the elderly or those recovering from sepsis.

The research suggests that when antibiotics disrupt the gut, it can lead to issues not just in the gut but also in the brain. Using a preclinical mouse model, researchers showed that antibiotic exposure depletes gut bacterial diversity and causes microbiome imbalance, which promotes the proliferation of K. pneumoniae by creating a favourable niche.

When this happens, K. pneumoniae can move from the gut into the bloodstream by passing through the gut lining and eventually reach the brain, triggering neuroinflammation and neurocognitive impairment.

The findings emphasise the potential risk hospital-acquired infections like K. pneumoniae may pose in the development of neurodegenerative diseases.

“Hospital-acquired and septic infections are one of the risk factors that may increase the predispositions to future neuroinflammatory and neurocognitive impairments, especially in older adults,” Nagpal said.

The study highlights the need for innovative therapeutic approaches to combat the rising prevalence of Alzheimer’s disease, in addition to existing amyloid and tau protein therapies. Further research could provide insight into preventive strategies aimed at managing hospital-acquired pathogens and preserving cognitive health in ageing populations.

The research was funded by the Infectious Diseases Society of America and the Florida Department of Health.

The paper was co-authored by graduate researchers Ian Park, Saurabh Kadyan, and Nathaniel Hochuli from the FSU College of Education, Health, and Human Sciences. Additional collaborators included Hazel K. Stiebeling Professor Gloria Salazar; Associate Professor of psychology and neuroscience Aaron Wilber; University of Florida researchers Orlando Laitano, Paramita Chakrabarty, and Philip A. Efron; and Wake Forest University School of Medicine Associate Professor M. Ammar Zafar.

Cognitive impairment in HD

Posted on November 30, 2024 by - Huntington's disease

Phase 2 DIMENSION Study fails to meet primary endpoint

Sage Therapeutics announced that its Phase 2 DIMENSION Study of dalzanemdor (SAGE-718) for cognitive impairment in Huntington’s disease failed to meet its primary and secondary endpoints. Dalzanemdor showed no statistically significant or clinically meaningful improvement versus placebo in the Symbol Digit Modalities Test at Day 84 or in secondary endpoints.

The 12-week, double-blind, placebo-controlled study included 189 participants. Dalzanemdor was well-tolerated, with most adverse events being mild to moderate and no new safety signals observed. However, the lack of efficacy has led Sage Therapeutics to discontinue further development of dalzanemdor.

As a result, the ongoing PURVIEW Study, an open-label safety trial of dalzanemdor, will also be closed. Sage Therapeutics expressed disappointment in the outcome but extended gratitude to participants and researchers involved.

Unlocking the blood-brain barrier?

Posted on November 29, 2024 by - Research

Researchers at the Icahn School of Medicine at Mount Sinai have developed an innovative approach—demonstrated in mouse models and isolated human brain tissue—to safely and effectively deliver therapeutics into the brain, providing new possibilities for treating a wide range of neurological and psychiatric diseases.

29 November 2024: Published in the November 25 online issue of Nature Biotechnology [https://doi.org/10.1038/s41587-024-02487-7], the study introduces a first-of-its-kind blood-brain barrier-crossing conjugate (BCC) system, designed to overcome the protective barrier that typically blocks large biomolecules from reaching the central nervous system (CNS).

The blood-brain barrier is a natural protective shield that prevents harmful substances from entering the brain. However, it also blocks the delivery of life-saving drugs, creating a significant challenge in treating conditions like amyotrophic lateral sclerosis (ALS), Alzheimer’s disease, addiction, and many other CNS disorders.

The BCC platform takes advantage of a specialised biological process called γ-secretase-mediated transcytosis to deliver large therapeutic molecules, like oligonucleotides and proteins, directly into the brain through a simple intravenous injection.

“The blood-brain barrier is an essential defense mechanism, but it also presents a significant challenge for delivering drugs to the brain,” says co-corresponding senior author Yizhou Dong, PhD, Professor of Immunology and Immunotherapy, and a member of the Icahn Genomics Institute and the Marc and Jennifer Lipschultz Precision Immunology Institute, at Icahn Mount Sinai. “Our BCC platform breaks this barrier, allowing biomacromolecules, including oligonucleotides, to reach the CNS safely and efficiently.”

The study showed that when the researchers injected a compound called BCC10 linked to specialized genetic tools known as antisense oligonucleotides into mice, it successfully reduced the activity of harmful genes in the brain. In a transgenic mouse model of ALS (a motor neuron disease), the treatment significantly lowered levels of the disease-causing gene called Sod1 and its associated protein. Similarly, a different antisense oligonucleotide linked to BCC10 greatly reduced another gene, Mapt, which encodes the tau protein and is a target for the treatment of Alzheimer’s disease and other dementias.

This development has the potential to advance treatments for a broad range of brain diseases

BCC10 proved to be highly effective at delivering these genetic tools to the brain, improving their ability to silence harmful genes in different models and even in samples of excised human brain tissue studied in the laboratory. Importantly, the treatment was well tolerated in mice, causing little or no damage to major organs at the tested doses, say the investigators.

Despite recent progress in the field, there is still a pressing need for technologies that can bypass the blood-brain barrier and improve the delivery of biomacromolecule-based therapies to the central nervous system via systemic administration. 

“Our platform could potentially solve one of the biggest hurdles in brain research—getting large therapeutic molecules past the blood-brain barrier safely and efficiently,” says co-corresponding senior author Eric J. Nestler, MD, PhD, Nash Family Professor of Neuroscience, Director of The Friedman Brain Institute, and Dean for Academic Affairs of Icahn Mount Sinai, and Chief Scientific Officer of the Mount Sinai Health System. “This development has the potential to advance treatments for a broad range of brain diseases.”

Next, the investigators plan to conduct further studies in large animal models to validate the platform and develop its therapeutic potential.

The paper is titled “Intravenous administration of blood-brain barrier-crossing conjugates facilitate biomacromolecule transport into central nervous system.”

The remaining authors, all with Icahn Mount Sinai except where indicated, are Chang Wang, MD; Siyu Wang, PhD; Yonger Xue, PhD; Yichen Zhong, BS (PhD Candidate); Haoyuan Li, MD; Xucheng Hou, PhD; Diana D. Kang, BS (PhD Candidate/Icahn Mount Sinai and Ohio State University); Zhengwei Liu, PhD; Meng Tian, PhD; Leiming Wang, PhD; Dinglingge Cao, PhD; Yang Yu, PhD (Ohio State University), Jayce Liu, BS (PhD Candidate, Ohio State University), Xiaolin Cheng, PhD (Ohio State University), Tamara Markovic, PhD; Alice Hashemi, BS; Brian H. Kopell, MD, and Alexander W. Charney, MD, PhD. 

First UK Neuro Forum

Posted on November 28, 2024 by - Uncategorised

UK Neuro Forum will focus on services and support for neuro conditions

28 November 2024: Andrew Gwynne MP, Parliamentary Under-Secretary of State at the Department of Health and Social Care, has announced today that a new UK Neuro Forum will be set up to find ways to improve care and support for people affected by neurological conditions.

The UK Neuro Forum will hold formal, biannual meetings across the Department for Health and Social Care, NHS England, devolved governments and Neurological Alliances of all four UK nations. Plans for the first forum meeting in early 2025 are in place, with a further meeting in the summer and ongoing bi-annual meetings in future.  

The announcement follows a long-standing campaign led by The Neurological Alliance together with The Neurological Alliance of Scotland, Wales Neurological Alliance and the Northern Ireland Neurological Charities Alliance and supported by over 100 organisations and more than 19,000 people.

It will aim to address unwarranted variation in access to care across the country, and drive person-centred care.

Andrew Gwynne, Minister for Public Health and Prevention, said:

“I am proud to welcome the launch of the UK Neuro Forum. This long overdue forum will help address common concerns and challenges experienced by people affected by neurological conditions, which are too often overlooked. This initiative will unite governments, clinical leaders and campaigners to tackle shared challenges and drive UK-wide collaboration to improve gaps in treatment and care of people with conditions that impact the nervous system.” 

“I am delighted we are announcing the launch of the UK Neuro Forum. Neurological conditions are the leading cause of disability worldwide and affect over 16 million people in the UK. This initiative brings together key stakeholders from across the UK for the first time, and aims to share learning to ensure patients receive the equitable care and treatment they need, with the goal of improving lives. This collaboration will bolster the ongoing work we are delivering through NHS England’s Neurology Transformation Programme.” 

Dr Niran Nirmalananthan, National Clinical Director for Neurology, NHS England

Hearing loss associated with PD

Posted on November 28, 2024 by - Movement Disorders, Parkinson’s Disease

  • Hearing loss is an independent risk factor for Parkinson’s disease, even after adjusting for confounders like age and head trauma.
  • Hearing screening and intervention may be crucial modifiable risk factors for both dementia and Parkinson’s disease.
  • Hearing aid use significantly reduces Parkinson’s disease incidence, but further studies are needed to assess adherence and other influencing factors.
  • The study’s generalisability is limited due to its predominantly White male veteran cohort, and causality remains unclear.

A recent study using electronic health records from over 3 million U.S. veterans has identified hearing loss as an independent risk factor for developing Parkinson’s disease (PD). Published in JAMA Neurology, the research revealed that hearing loss increases PD risk even when adjusting for factors like age, head trauma, and prodromal disorders. Researchers suggested that hearing screening and intervention might be low-cost, low-risk strategies to reduce this risk.

The study analysed data from veterans who underwent audiograms between 1999 and 2022, with a follow-up period averaging 7.6 years. Of the cohort, 20.8% had normal hearing. Veterans with mild hearing loss showed a higher incidence of PD at intervals of 5 to 20 years compared to those with normal hearing. Hearing loss was associated with a 26% increased PD risk over 10 years (hazard ratio: 1.26, 95% CI, 1.2-1.32). The risk grew with the severity and duration of hearing loss.

Interestingly, the combination of hearing loss and prodromal PD disorders increased PD risk beyond the expected individual contributions, accounting for up to 21.7 additional PD cases per 10,000 people. Hearing aids appeared to mitigate this risk. When prescribed within two years of hearing loss detection, they significantly reduced the incidence of PD, with benefits observable within a year. The study estimated that treating 462 individuals with hearing aids could prevent one PD case over 10 years.

When prescribed within two years of hearing loss detection, hearing aids significantly reduced the incidence of PD

Despite its insights, the study had limitations. The predominantly White, male veteran cohort limits the generalisability of the findings. Other factors, such as ototoxic drug exposure and adherence to hearing aid use, were not examined. Further research is needed to explore causality, mechanisms, and whether benefits extend to broader populations. These findings underline the potential of hearing interventions in reducing PD risk, particularly in high-risk groups.

Reference

1. Neilson LE, Reavis KM, Wiedrick J, et al. Hearing loss, incident Parkinson disease, and treatment with hearing aids. JAMA Neurol. Published online October 21, 2024. Hearing Loss, Incident Parkinson Disease, and Treatment With Hearing Aids | Movement Disorders | JAMA Neurology | JAMA Network

This is an AI generated article summary.

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Traumatic Brain Injury – more catastrophic in children?

Posted on November 27, 2024 by - Acquired Brain Injury

Study reveals differences in brain pathology between paediatric and adult patients following traumatic brain injury

Prof Willie Stewart
Professor Willie Stewart, Glasgow University

26 November 2024: A study led by Professor Willie Stewart from the University of Glasgow has revealed differences in the brains of paediatric and adult patients’ that might explain the sometimes catastrophic outcomes seen in children following a traumatic brain injury.

In findings published in the journal JAMA Network Open, the researchers found first pathological evidence that the pattern of damage to blood vessels after a severe brain injury appears to be age-dependent. Specifically, in adult brains, vessels showing signs of damage after trauma were often medium or larger sized. In contrast, in paediatric patients, it was typically the smallest sized vessels, or capillaries, that were damaged.

For the study, the researchers studied postmortem brain tissue samples from 81 paediatric patients (aged 3-18 years) and 62 (aged 19 or over) adults who died shortly after sustaining a traumatic brain injury.

In addition to the vascular pathology, severe brain swelling was far more common among the paediatric cases examined, which the authors suggest might be a result of the differences in blood vessel damage seen after trauma. 

Traumatic brain injury represents the leading cause of death and permanent disability in young children and adolescents. Compared to adults, there is an increased risk of catastrophic outcomes in younger patients following TBI, including diffuse brain swelling and so-called ‘second impact syndrome’. However, up until now, the cause of these poorer outcomes in pediatric patients were unclear.

Led by consultant neuropathologist Prof Willie Stewart, Honorary Professor at the University of Glasgow, the study provides crucial first information into important differences in the response of blood vessels in the brain to injury in paediatric compared to adult patients.

Prof Willie Stewart said: “This research has considerable implications in terms of understanding TBI in younger people. In contrast to adults, pediatric patients appear especially vulnerable to catastrophic outcomes, which can arise following all injury severities, including mild TBI or concussion. Given this, further research in this area is needed.

“In the meantime, these findings reinforce the reasoning behind our, ‘If in doubt, sit them out’ approach to concussion management, especially with younger players and in sports like rugby.”

In previous findings from Prof Willie Stewart and collaborators, the researchers found that former international rugby players had an approximately two and a half times higher risk of neurodegenerative disease than expected, with risk of disease varying by subtype, but not by player position. And in the landmark FIELD study, which was funded by The Football Association and The Professional Footballers Association, the research team reported the first data on neurodegenerative risk among former professional footballers. 

These findings reinforce the reasoning behind our, ‘If in doubt, sit them out’ approach to concussion management, especially with younger players and in sports like rugby.

Professor Willie Stewart

In parallel work, also led by Professor Stewart, a specific pathology linked to brain injury exposure, known as chronic traumatic encephalopathy (CTE), has been described in a high proportion of the brains of former contact sport athletes, including former rugby players.

The paper ‘Pediatric traumatic brain injury and microvascular blood-brain barrier pathology,’ is published in JAMA Network Open. The study was supported by the Glasgow Children’s Hospital Charity grant; the National Institutes of Health (NIH); the Department of Defense; and an NHS Research Scotland Senior Fellowship. 

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