BREAKING STORY -- Alzheimer’s disease patients now have another medication option that may help slow the progression of the disease, and Citizens Memorial Hospital (CMH) patients played a role in the drug’s approval. The Food and Drug Administration approved Kisunla (donanemab) July 2 for the treatment of early-stage Alzheimer's disease. Kisunla (donanemab) is the first FDA-approved drug for which patients at CMH in Bolivar, Missouri, participated in the clinical research trial that led to FDA approval. Through Missouri Memory Center and CMH Research Department, 15 patients have participated in clinical research studies for the drug since March 2021. “This is the second drug treatment for Alzheimer’s disease that the FDA has approved in less than a year,” said Curtis P. Schreiber, M.D., board-certified neurologist and medical director of Missouri Memory Center and CMH Research Department in Bolivar. “What makes this drug approval even more exciting is that we had, and still have, patients at Missouri Memory Center who participated in the clinical research study. Their participation helped provide the necessary evidence that the drug is effective in significantly slowing cognitive and functional decline in patients with early symptomatic Alzheimer’s disease.” Eli Lilly and Company International filed for FDA approval last year. The company presented full study results at the Alzheimer’s Association International Conference in Amsterdam, Netherlands, in July 2023. “We are rapidly progressing in the field of Alzheimer’s testing and treatment, and it is exciting to have yet another option for slowing the progression of Alzheimer’s disease,” said Dr. Schreiber. “With the availability of these drugs, it is even more important to diagnose Alzheimer’s disease early.” Free cognitive screenings are available on the third Friday of every month at Missouri Memory Center in Bolivar. Call 417-327-3530 for more information or to schedule an appointment. The Missouri Memory Center at CMH continues to provide specialized care to people in our region with memory concerns, including Alzheimer’s disease. The CMH Research Department has opportunities for patients interested in participating in clinical trials studying new treatments for Alzheimer’s disease. For more information about the CMH Neurology & Headache Center, Missouri Memory Center or CMH Research Department, call 417-328-7781 or email [email protected]. For more information about Lilly’s Kisunla, visit https://bit.ly/3W8ixxe.
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President/CEO @ Midwest Spine & Brain Institute | Founder HyperCharge Performance, Longevity and Recovery Clinics | Wellness at the Speed of Light Podcast Host | Recharging the Human Battery Radio Show Host | Speaker
Is Eli Lilly’s recently FDA endorsed Alzheimer’s drug a true game changer? My interest in Alzheimer’s disease (AD) goes back to the mid 1990s to when I was doing research at the Neuropathology Lab at Albert Einstein in the Bronx under Dr Dennis Dickson, but also seeing it affect my own family. AD is a devastating public health concern globally. In the U.S., an estimated 6.9 million Americans aged 65 and older are living with Alzheimer's in 2024, a number projected to nearly double to 13.8 million by 2060. Alzheimer's disease was the fifth-leading cause of death among people aged 65 and older in 2021. Globally, over 55 million people were living with dementia in 2020, with this number expected to almost double every 20 years, reaching 78 million in 2030 and 139 million by 2060. There is an urgent need for effective treatments and support systems for patients and caregivers worldwide. This week, the FDA Panel Endorsed Eli Lilly's donanemab, a monoclonal antibody designed to slow early symptomatic Alzheimer's progression, confirming its safety and efficacy. Donanemab targets the N3pG epitope in brain amyloid plaques, hallmarks of Alzheimer's linked to cognitive decline. By binding these plaques, donanemab facilitates their clearance through microglial phagocytosis, potentially slowing disease progression. In the Phase 3 TRAILBLAZER-ALZ 2 study with 1,736 early Alzheimer's patients: ✅Primary Endpoint - A 35% slowing of decline on the Integrated Alzheimer's Disease Rating Scale in participants ✅Secondary Endpoints: A 36% slowing of decline on the Clinical Dementia Rating and a 40% reduction in the decline of daily living activities. ✅Amyloid Clearance: Donanemab reduced amyloid plaque levels by 84% at 18 months, compared to a 1% decrease in the placebo group. 👉🏽Notable adverse events included brain swelling/microhemorrhages in 24% of donanemab patients vs 2.1% for placebo. However, benefits outweighed risks for early-stage patients. This endorsement highlights early intervention's importance and paves the way for combination therapies. Eli Lilly continues exploring donanemab's potential, including preventing symptomatic Alzheimer's in preclinical stages. Further Thoughts: One exciting avenue may be the potential combination of donanemab with transcranial photobiomodulation (tPBM). This non-invasive therapy uses near-infrared light to stimulate brain cells, potentially enhancing cognitive function and reducing inflammation. Combining donanemab with tPBM could increase efficacy and reduce side effects, offering a more comprehensive approach to Alzheimer's treatment. 28 years ago we released this 👉🏽 Neurobiology of Aging Volume 17, Issue 5, September–October 1996, Pages 733-743 Glycation and microglial reaction in lesions of Alzheimer's disease Authors: Dennis W. Dickson, Stefano Sinicropi, Shu-Hui Yen, Li-Wen Ko, Linda A. Mattia, Richard Bucala, Helen Vlassara #Alzheimers #Donanemab #FDAApproval #ClinicalTrials
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Valsartan: more than a decade of experience Henry R Black 1, Jacqueline Bailey, Dion Zappe, Rita Samuel Affiliations expand PMID: 19911855 DOI: 10.2165/11319460-000000000-00000 Abstract Valsartan is a nonpeptide angiotensin receptor antagonist that selectively blocks the binding of angiotensin II to the angiotensin II type 1 receptor. The efficacy, tolerability and safety of valsartan have been demonstrated in large-scale studies in hypertension, heart failure (HF) and post-myocardial infarction (MI). This review focuses on what was learned from the valsartan clinical research programme and other comparative trials published from 1997 to the present. Many studies have demonstrated the efficacy of valsartan in lowering blood pressure (BP) in a variety of patient populations (including elderly, women, children, obese patients, patients with diabetes mellitus, patients with chronic kidney disease [CKD], patients at high risk of cardiovascular [CV] disease, African Americans, Hispanic Americans and Asians) and in improving outcomes in CV disease and CKD. In hypertension, valsartan exhibits dose-dependent efficacy in reducing both systolic and diastolic BP over the once-daily dose range of 80-320 mg; doses as high as 640 mg/day have been studied and found to be efficacious and safe. BP control can be enhanced with a more consistent 24-hour BP-lowering profile by using single-pill, fixed-dose combination therapy with valsartan plus hydrochlorothiazide (HCTZ). The cardioprotective benefits of valsartan have been demonstrated in large-scale outcome trials and include significant reductions in CV morbidity and mortality in HF, following MI, and in patients with co-morbid hypertension and coronary artery disease and/or HF; reductions in HF hospitalizations; and reductions in the incidence of stroke. The magnitude of these effects is comparable with that demonstrated with angiotensin-converting enzyme (ACE) inhibitors; however, valsartan has a more favourable tolerability profile, with a significantly lower incidence of cough and only rare reports of angio-oedema, both class effects of ACE inhibitor use. Consistent with its angiotensin receptor-blocking effects, valsartan also reduces circulating levels of biochemical markers that are associated with angiotensin II-mediated endothelial dysfunction and CV risk (e.g. high-sensitivity C-reactive protein or oxidized low-density lipoprotein).
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Denovo Biopharma's ENLIGHTEN trial has shown promising results for the treatment of treatment-resistant depression (TRD). Liafensine, a triple reuptake inhibitor developed by Denovo, was found to be effective in treating TRD patients using their DGM4™ predictor. The trial enrolled 197 patients with TRD, using DGM4™ to guide randomization. DGM4-positive patients treated with liafensine showed significant improvement over placebo after 6 weeks. Liafensine was well tolerated with an excellent safety profile consistent with previous trials involving over 2,200 subjects. Over 23 million Americans suffer from major depressive disorder (MDD), and 30% have TRD, which is notoriously challenging to treat. With few approved medications and poor outcomes, TRD remains a significant medical need. The results of this trial represent a breakthrough in precision medicine for CNS diseases, as it is the first time a genetic biomarker has been used to select TRD patients likely to benefit from liafensine. Denovo is actively seeking a global partner to expedite the development of liafensine, aiming to provide this treatment to millions of patients in need. This milestone for Denovo validates their innovative biomarker approach and represents hope for those struggling with TRD. Wen Luo
Denovo Biopharma’s Revelation: Precision Treatment for Depression’s Grip
https://www.clinicaltrialvanguard.com
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📌 New Case Western Reserve University study finds diabetes drug may reduce risk for colorectal cancer Excerpt: A #groundbreaking study by researchers at Case Western Reserve University suggests a class of medications used to treat type 2 diabetes may also #reduce the #risk of #colorectal #cancer (CRC). The findings, published today (Dec. 7, 2023) in the journal JAMA Oncology, support the need for clinical trials to determine whether these medications could prevent one of the deadliest types of cancers. Eventually, the medications may also show promise in warding off other types of cancer associated with obesity and diabetes. 🔸 “Our results clearly demonstrate that #GLP-1 #RAs are significantly #more #effective than popular anti-diabetic drugs, such as Metformin or insulin, at #preventing the development of CRC,” said Nathan Berger, the Hanna-Payne Professor of Experimental Medicine at Case Western Reserve School of Medicine and the study’s co-lead researcher. 🔸 Glucagon-like peptide-1 receptor agonists, or GLP-1 RAs, are medications to treat type 2 diabetes. Usually given by injection, they can lower blood-sugar levels, improve insulin sensitivity and help manage weight. They’ve also been shown to reduce the rates of major cardiovascular ailments. Importantly the protective effect of GLP-1 RAs are noted in patients with or without overweight/obesity. 🔸 “To our knowledge,” said co-lead researcher Rong Xu, “this is the first indication this popular #weightloss and #antidiabetic class of drugs reduces incidence of CRC, relative to other anti-diabetic agents.” 🔸 Using a national database of more than 100 million electronic health records, the researchers conducted a population-based study of more than 1.2 million patients. These individuals had been treated with anti-diabetic agents from 2005-19; the CWRU team examined the effects of GLP-1 RAs on their incidence of CRC, as compared to those prescribed other anti-diabetic drugs. 🔸 #Population-#based #research means matching as many people as possible with the same characteristics—sex, race, age, socio-economic determinants of health and other medical conditions—to accurately compare the drug’s effects. Among 22,572 patients with diabetes treated with insulin, there were 167 cases of CRC. Another 22,572 matched patients treated with GLP-1 RAs saw 94 cases of CRC. Those treated with GLP-1 RAs had a 44% reduction in incidence of CRC. 🔸 In a similar comparison of 18,518 patients with diabetes treated with Metformin, compared to 18,518 patients with diabetes treated with GLP-1 RAs, had a 25% reduction in CRC. “The research is critically important for reducing incidence of CRC in patients with diabetes, with or without overweight and obesity,” Berger said. Read ➡ https://lnkd.in/dKuYE65M #colorectalcancer #diabetesmedication
New Case Western Reserve University study finds diabetes drug may reduce risk for colorectal cancer
https://thedaily.case.edu
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41K I Global Medical Journal I 18th Year I Houston I Istanbul I Clinical Trials I Innovative Therapies I Patient Journey I Ethics
Lundbeck is enhancing its research and development in neurohormonal dysfunctions. A key part of this strategy is the development of Lu AG13909, a first-in-class monoclonal antibody (mAb) that targets the adrenocorticotropic hormone (ACTH). By binding to ACTH with high affinity, Lu AG13909 aims to reduce elevated ACTH levels, potentially providing therapeutic benefits for individuals with neurohormonal dysfunctions. In a recent development, a phase II clinical trial assessing efficacy, safety, and tolerability of Lu AG13909 as a potential treatment for Cushing’s disease, has been initiated. “We are pleased to advance this new approach to potentially treating unmet needs in Cushing’s disease, a condition that, when uncontrolled, is debilitating and increases mortality,” said Johan Luthman, EVP and Head of Research & Development at Lundbeck. With the latest initiated trial, Lundbeck is currently investigating Lu AG13909 for two conditions: Cushing’s disease and congenital adrenal hyperplasia. These ongoing clinical trials underscore Lundbeck’s commitment to innovation and expanding treatment options for people with rare neurohormonal dysfunctions. Lu AG13909: A potential treatment for people with Cushing’s disease Cushing’s disease is a serious condition caused by a pituitary adenoma leading to excessive production of ACTH, which in turn stimulates the adrenal glands to produce high levels of cortisol. This hormonal imbalance results in clinical manifestations such as weight gain, fatigue, muscle weakness, hypertension, diabetes, obesity, and can lead to early death. Lu AG13909, a potential cornerstone in the pharmacological treatment of Cushing’s disease, is an antibody designed to target ACTH with high precision thereby neutralising the actions of ACTH. Consequently, Lu AG13909 is expected to reduce pathologically elevated ACTH signaling and thus provide a therapeutic benefit to patients with Cushing’s disease. This innovative approach may be a significant step forward in managing the disease. Lu AG13909: Unveiling new possibilities for people with congenital adrenal hyperplasia Congenital adrenal hyperplasia is a rare disorder characterized by an enzyme deficiency which disrupts adrenal steroidogenesis leading to cortisol and aldosterone deficiency and consequently increased ACTH levels. The increased ACTH levels stimulate the adrenal glands, leading to adrenal hyperplasia and androgen excess, causing the clinical features of congenital adrenal hyperplasia. People with congenital adrenal hyperplasia are at risk of adrenal crisis, a life-threatening condition. The challenge lies in balancing glucocorticoid replacement therapy and controlling hyperandrogenism, with the risk of long-term consequences of glucocorticoid overtreatment. #neurohormonaldysfunctions #Cushingsdisease #mAb #ACTH #Lundbeck
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New Treatment for Early Alzheimer’s Disease #medicine Kisunla (Donanemab-azbt) just approved by the FDA for the treatment of early symptomatic Alzheimer's Disease (AD). https://lnkd.in/dpuJFisA Why is this important? Kisunla slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study and reduced participants' risk of progressing to the next clinical stage of disease by up to 39%. Kisunla is the first and only amyloid plaque-targeting therapy that used a limited-duration treatment regimen based on amyloid plaque removal; nearly half of study participants completed their course of treatment with Kisunla in 12 months. Once-monthly infusions of 30 minutes reduced amyloid plaques on average by 84% compared to the start of the study. Highlights from clinical trial In the TRAILBLAZER-ALZ 2 Phase 3 study, people who were the least advanced in the disease experienced the strongest results with Kisunla. Trial participants were analyzed over 18 months in two groupings: one group who was less advanced in their disease (those with low to medium levels of tau protein) and the overall population, which also included participants with high tau levels. Treatment with Kisunla significantly slowed clinical decline in both groups. Those individuals treated with Kisunla who were less advanced in their disease showed a significant slowing of decline of 35% compared with placebo on the integrated Alzheimer's Disease Rating Scale (iADRS), which measures memory, thinking, and daily functioning. In the overall population, the response to treatment was also statistically significant using the iADRS at 22%. Among the two groups analyzed, participants treated with Kisunla had up to a 39% lower risk of progressing to the next clinical stage of disease than those taking placebo. Among the overall population of participants, Kisunla reduced amyloid plaques on average by 61% at 6 months, 80% at 12 months, and 84% at 18 months compared to the start of the study. What is Kisunla? Donanemab (LY3002813) is a humanized IgG1 monoclonal antibody targeted against an epitope at the N-terminal of a specific type of amyloid beta (Aβ) - pyroglutamate Aβ - which is found only in the brain amyloid plaques associated with AD. It works by inducing microglial-mediated clearance of existing Aβ plaques with the intent of slowing the progressive decline in cognitive function associated with AD. #pharmaceuticals #healthcare
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Professor of Neurology, Advocate of precision medicine in neurodegenerative diseases, co-founder of Regain Therapeutics, evaluating treatments to correct proteinopenia.
Is lowering glucosylceramide in GBA1-associated Parkinson's disease beneficial? A well-designed and executed clinical trial indicates the answer is No. https://lnkd.in/gkJVWPbQ This is the hypothesis tested in a nutshell: Since high CSF glucosylceramide, due to low glucocerebrosidase activity (the lysosomal enzyme encoded by GBA1), accelerates clinical worsening, lowering glucosylceramide through the glucosylceramide synthase inhibitor venglustat, which also reduces "toxic" α-synuclein aggregates, should be good for people with Parkinson's associated with a GBA1 mutation. The results of the MOVES-PD Trial are in. This 52-week randomized, double-blind clinical trial allocated 110 PD-GBA patients to venglustat, 111 to placebo (mean age, 59 years; disease duration: 6.5 years). Venglustat lowered glucosylceramide but increased (worsened) the MDS-UPDRS parts II and III by 7.3 (SE 1.4) vs. placebo, 4.7 (1.3), a 2.6-point difference in favor of placebo. The temptation is to blame other factors (e.g., a negative symptomatic effect, a greater placebo effect, or pharmacokinetic shortcomings), not to reject the trial hypothesis. Yet, in this case, although the intervention met target engagement, the clinical outcome was opposite to that hypothesized. Thus, the hypothesis should be rejected. Further supporting the conclusion that the hypothesis is false, these results mirror those in mice overexpressing α-synuclein (Thy1-aSyn line 61 and AAV-aSyn GBA) in which venglustat lowered glucosylceramide, reduced soluble and membrane-bound α-synuclein, and worsened motor function. https://lnkd.in/gYWNns38 Clinical trials should be conducted to test hypotheses, and results interpreted without emotions. The venglustat trial result is not “disappointing” or “unexpected," as the authors describe. It was the result of a well-executed trial. We now should look for an alternative hypothesis.
Safety and efficacy of venglustat in GBA1-associated Parkinson's disease: an international, multicentre, double-blind, randomised, placebo-controlled, phase 2 trial
thelancet.com
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Donanemab (Kisunla): A Promising Treatment for Alzheimer's Disease Donanemab, also known by its brand name Kisunla, is a monoclonal antibody used for the treatment of Alzheimer’s disease. It is designed to slow down the decline in memory, thinking, and daily functioning associated with Alzheimer’s. Here are some key points about Donanemab: Mechanism Of Action The monoclonal antibody Donanemab targets amyloid plaques in the brain, which are thought to contribute to Alzheimer’s symptoms. By helping the body remove these plaques, it slows the progression of the disease. FDA Approval Donanemab received FDA approval on July 2, 2024, as a treatment for adults with early symptomatic Alzheimer’s disease (including those with mild cognitive impairment) and confirmed amyloid pathology. Clinical Trial Results In the TRAILBLAZER-ALZ 2 clinical trial, it is significantly slowed Alzheimer’s disease progression by more than 20% at 76 weeks. Patients in earlier stages of the disease showed the most significant improvements. Common Side Effects Headache and swelling in brain areas (with or without small spots of bleeding) occurred in at least 10% of patients. Serious Side Effects Serious allergic reactions (swelling of face, difficulty breathing, hives) and infusion-related reactions (sweating, headache, nausea, chest pain) may occur. Donanemab represents a promising advancement in Alzheimer’s treatment, and its approval provides hope for patients and their families. Source: Medical News Today
Donanemab
https://newpetc.com
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