Moe Alsumidaie’s Post

NEW PAPER: Baseline Mismatch Negativity Amplitude Predicts Direction & Magnitude of Ketamine Effect in Healthy Volunteers - A “Disordinal” Effect This research study from our team at Cognision was conducted in collaboration with EEG/ERP Biomarker Qualification Consortium. PREPRINT: https://lnkd.in/gwmdrnhF BACKGROUND: Mismatch negativity (MMN) is a component of the auditory event-related potential (ERP) that is elicited during a passive oddball paradigm where task-irrelevant infrequent deviants are presented in a stream of more frequent standard stimuli. MMN is believed to index a pre-attentive stage of auditory information processing closely linked to N-methyl-D-aspartate receptors (NMDAR). Ketamine is thought to act primarily as an NMDAR antagonist, has been used in clinical trials to model the symptoms of schizophrenia and is increasingly used in the clinic to treat depression. Various studies have reported that ketamine reduces MMN amplitude which, in turn, might reflect reduced function of NMDAR-mediated neurotransmission. Nonetheless, there is growing evidence showing MMN amplitude either having high variability or, paradoxically, moving in the opposite direction after ketamine in different individuals. METHODS: We analyzed results from three independent ERP studies to test the hypothesis of a cross-over interaction (“disordinal” drug effect) between the duration-deviant MMN at baseline (without ketamine) and the direction and magnitude of the ketamine effect. To rule out regression to the mean (RTM), a statistical phenomenon that may also partially explain this cross-over interaction, we separately estimated RTM using a drug-free test-retest study. RESULTS: Our results are the first to statistically demonstrate the existence of a disordinal drug response to ketamine, where the direction and magnitude of ketamine-induced changes in MMN amplitude can be predicted by baseline MMN amplitude. CONCLUSIONS: These new insights may contribute to novel precision medicine approaches to treatment of CNS disorders. ⭐️ Contact our team to learn more about implementing EEG/ERP biomarkers in clinical trials. #neuroscience #mentalhealth #pharmaceuticals #clinicaltrials #biomarkers #precisionmedicine

Breakthroughs in Parkinson’s disease treatment are accelerating, and Tavapadon is emerging as a potential game-changer. Interim results from the Phase 3 open-label extension trial (TEMPO‑4) demonstrate sustained motor improvements with a reassuring long-term safety profile — no new safety signals were observed. AbbVie has filed a New Drug Application based on the TEMPO program, positioning Tavapadon as the first oral D1/D5 partial agonist for Parkinson’s disease. Innovation extends beyond dopamine. Solengepras (CVN424), a once-daily oral non-dopaminergic GPR6 inverse agonist from Cerevance, showed encouraging functional and non-motor benefits in the Phase 2 ASCEND trial for early PD. Its pivotal Phase 3 ARISE trial (≈330 patients, adjunctive therapy) is underway, with topline results expected H1 2026. cerevance.com These developments suggest a more hopeful landscape for Parkinson’s care. Patients may soon have access to oral therapies that address both motor and non-motor symptoms, while clinicians can look forward to more options to tailor treatment. For researchers and the industry, the progress of D1/D5 and GPR6 programs shows that Parkinson’s drug development is embracing novel, mechanism-driven approaches. Long-term durability and real-world effectiveness are still being evaluated, but the momentum is clear: a new generation of Parkinson’s therapies is on the horizon. #ParkinsonsDisease #Neurology #DrugDevelopment #Tavapadon #Solengepras #InnovationInPD https://lnkd.in/d7h9a-xe

Australia greenlights Leqembi—but only for genotype-defined early Alzheimer’s patients, embedding precision neurology into real-world access. The TGA approved lecanemab for adults with early Alzheimer’s who are APOE ε4 non-carriers or heterozygotes, reversing its earlier rejection. The decision reflects Phase 3 Clarity AD data showing a 33% slower cognitive decline at 18 months in this population, with ARIA observed in 17% (symptomatic 2%). Access now depends on genetic testing, amyloid confirmation, and MRI monitoring, prioritizing centers with diagnostic capacity and elevating the role of Medical Affairs in guiding risk stratification and HCP education. Strategically, this underscores a global pivot toward precision-titrated Alzheimer’s care, where genetic and biomarker stratification is central to regulatory, commercial, and payer strategies. Manufacturers must navigate operational complexity, cost management, and service infrastructure, while payers weigh whether genotype-driven segmentation meaningfully improves cost-effectiveness. For patients, clinicians, and health systems, early adoption will hinge on integrating testing, monitoring, and therapy into a cohesive care pathway. Will genotype-defined access become the new standard for disease-modifying Alzheimer’s therapies—or remain an Australia-specific compromise to balance safety, efficacy, and system readiness? 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞: https://lnkd.in/diyzHkPY #alzheimers #precisionmedicine #biotech #neurology #drugdevelopment Jane Grogan

Roche announced that the FDA has cleared its Elecsys pTau181 blood test, designed to identify individuals aged 55 and older with early signs of cognitive decline who do not exhibit Alzheimer's-related amyloid #pathology. https://lnkd.in/dzktQTku #Alzheimers #dementia #diagnostics #FDA #neurology #pharmaceuticals #productapprovals #regulatoryaffairs

Preclinical common data elements: a practical guide for use in epilepsy research: ... data quality is improved, meta-analyses for preclinical epilepsy research can be more easily conducted and evaluation of translational therapies ...

🚀 Breakthrough in Essential Tremor Treatment Announced by AbbVie! A significant advancement has emerged for millions affected by upper limb essential tremor. AbbVie’s Phase 2 ELATE trial revealed promising results for onabotulinumtoxinA (BOTOX®), showing a statistically significant reduction in tremor symptoms compared to placebo. This condition impacts up to 60 million people worldwide, often disrupting daily life and causing psychological distress. Current treatment options have been limited, making these findings especially impactful. Highlights from the trial include: ✔️ Achievement of the primary endpoint with notable improvements in the Tremor Disability Scale-Revised at week 18 ✔️ Successful fulfillment of all six secondary endpoints, indicating broad therapeutic potential ✔️ A safety profile consistent with known effects, with mostly mild to moderate and transient muscular weakness While regulatory approval for this indication is still pending, these results signal a promising new direction in managing essential tremor. Detailed findings will be presented at the International Congress of Parkinson’s Disease and Movement Disorders, marking a pivotal moment in movement disorder therapy. Patients and clinicians are encouraged to stay informed as this innovative treatment pathway continues to evolve. #AbbVie #BOTOX #ClinicalResearches #EssentialTremor #HealthcareInnovation #MedicalResearch #MovementDisorders #Neurology #PatientCare #PharmaceuticalCompanies #RegulatoryAgencies #MarketAccess #MarketAccessToday

🚀 Big Milestone for atai Life Sciences & Beckley Psytech: FDA Grants Breakthrough Therapy Designation to BPL-003 Exciting news in mental health therapeutics: Atai Beckley just announced that the U.S. FDA has granted Breakthrough Therapy Designation (BTD) to BPL-003, their proprietary intranasal formulation of mebufotenin (5-MeO-DMT), for the treatment of treatment-resistant depression (TRD). Why is this such a big deal? 👉 Breakthrough Therapy Designation is one of the most significant regulatory milestones in biotech. It’s reserved for therapies addressing serious or life-threatening conditions where early data show substantial improvement over existing treatments. Beyond the recognition itself, BTD brings closer FDA collaboration, more intensive guidance, and the possibility of faster development and review timelines. 👉 Perhaps most importantly, it dramatically improves a program’s probability of success. Historical data show that drugs with Breakthrough Therapy Designation have an approval success rate of ~76% — roughly 7x the industry average for a newly clinical stage drug — highlighting just how pivotal this moment is for BPL-003. 👉 The designation follows compelling Phase 2b results: a single dose of BPL-003 produced rapid and clinically meaningful reductions in depressive symptoms within 24 hours, with effects sustained over 8 weeks. Most patients were ready for discharge just 90 minutes post-dose, a paradigm-shifting feature that could make interventional psychiatry treatments more scalable and accessible. 👉 With Phase 3 trials expected to start in 2026, BPL-003 now joins a small and distinguished group of leading biotech companies recognized by the FDA with BTD. This is also a clear signal that the psychedelic therapeutics field is maturing from early promise to clinical and commercial reality. For the millions struggling with treatment-resistant depression — a condition that affects a third of all people with depression — this milestone is more than regulatory validation. It’s a strong sign that faster-acting, longer-lasting, and more scalable mental health treatments are within reach. Congratulations to the teams at Atai Beckley on achieving this critical milestone. Moments like this show how bold science, rigorous development, and smart regulatory strategy can come together to reshape the future of mental health care. #MentalHealth #Psychedelics #Pharma #Innovation #Spravato #TRD #InterventionalPsychiatry #atai #BPL003 #compasspathways #Biotech #MentalHealth #Neuropsychiatry #CNS #Neuroscience #depression #psychiatry #psychology #Pharma #therapy #mdd #treatmentresistantdepression #beckley #atai #suicidality #suicide #mdma #ibogaine #dmt #psilocybin #lsd #5meodmt #5meo #BreakthroughTherapy

Can a diabetes drug slow cognitive decline in Alzheimer’s disease? That’s the central question behind Novo Nordisk’s EVOKE and EVOKE+ trials, where the company is testing oral semaglutide (Ozempic) in patients with early-stage Alzheimer’s. Here’s why scientists and investors are paying attention: The Scientific Rationale: A New Path Beyond Amyloid For decades, Alzheimer’s research was dominated by the amyloid hypothesis. But repeated clinical failures have forced the field to explore broader mechanisms. Semaglutide, a GLP-1 receptor agonist, offers a multi-modal approach: ✅ Reduces neuroinflammation GLP-1 receptors in the brain, when activated, calm microglial overactivation and reduce pro-inflammatory cytokines. ✅ Improves brain insulin signaling Alzheimer’s is sometimes called "type 3 diabetes" due to impaired glucose metabolism in neurons. Semaglutide may restore this pathway. ✅ Enhances vascular health & synaptic plasticity GLP-1 agonists improve blood vessel integrity and may support neurogenesis and synaptic connectivity. The EVOKE Trials: Scientific Design, Not Hype Patient Population: ~3,680 patients aged 55–85 with mild cognitive impairment (MCI) or early-stage Alzheimer’s. All have confirmed amyloid positivity via PET or CSF testing. Treatment: 14 mg oral semaglutide, once daily for 2 years vs. placebo. Primary Endpoint: Not "reversal" but slowing of cognitive decline as measured by the CDR-SB score (a standard clinical tool in AD research). Topline Data Expected: Late 2025 Why It Matters If successful, this trial could redefine how we treat Alzheimer’s which will be not by targeting amyloid alone, but by addressing metabolism, inflammation, and vascular health simultaneously. It’s a high-risk, high-reward scientific pivot, and one of the most closely watched readouts in neurodegenerative drug development. What’s your take on GLP-1 drugs in neurodegenerative disease? #Alzheimers #Semaglutide #Ozempic #Neurodegeneration #ClinicalTrials #GLP1 #Neuroscience #Biotech #neurodegdecoded

🧠 A Major Step Forward in Alzheimer’s Diagnostics The U.S. FDA has approved a new blood test designed to aid in ruling out cognitive decline caused by Alzheimer’s disease — marking an important milestone for early and accessible diagnostics. Developed by Roche and Eli Lilly, the Elecsys pTau181 test measures a specific form of tau protein (pTau181) in the blood — a key biomarker of Alzheimer’s disease. In a clinical trial of 312 participants, it was able to rule out Alzheimer’s 97.9% of the time. Unlike traditional diagnostics that require spinal taps or advanced imaging, this blood test is FDA-cleared for primary care use, making it much easier to help identify whether memory and cognitive symptoms may stem from Alzheimer’s or other causes. This follows another FDA-approved test — Lumipulse, by Fujirebio — which measures a different biomarker ratio (pTau217 and amyloid-β 1–42). Together, these tests represent a growing shift toward faster, cheaper, and more scalable diagnostics in the fight against dementia. However, experts caution that some patients may still fall into a “grey zone” requiring further testing. Full validation and real-world data will be key to understanding accuracy and practical use. Still, this progress signals a transformative moment for early Alzheimer’s detection — and potentially for longevity science more broadly. At www.riskinsight.ch, we conduct longevity research for businesses working at the intersection of aging, biomarkers, and healthspan — helping translate scientific breakthroughs like this into actionable insight. Read the article here: https://lnkd.in/dQ6fwPpe #Longevity #Alzheimers #Diagnostics #Biomarkers #Neuroscience #HealthcareInnovation #Aging

#Alzheimer’s #neuroscience #dementia #medicine #medicalsciences #research https://lnkd.in/gm8Vdbfv Alzheimer’s blood test approved for roll-out The US Food and Drug Administration has approved a blood test to rule out Alzheimer’s in people with cognitive decline. It is the second blood test approved to aid in the diagnosis of Alzheimer’s and the first cleared for use in primary care, such as at the doctor’s office. In a trial of 312 people, the blood test correctly measured Alzheimer’s-related tau proteins to rule out the disease 97.9% of the time, according to the pharma company Roche. But without access to the full trial data, it’s difficult to independently assess the test’s accuracy, says neurologist Ashvini Keshvan. The blood test is unlikely to replace other diagnostic tools, such as sampling cerebrospinal fluid or neuroimaging, but could provide a first step to diagnosing the cause of cognitive decline.