Archive for category: News

In a study conducted in Shanghai, China, researchers have discovered a promising blood biomarker that could aid in the early detection of mild cognitive impairment (MCI), often considered a precursor to Alzheimer’s disease (AD). The study, which involved participants from the Heqing Community, has shed light on the potential role of red blood cell distribution width (RDW) in identifying individuals at risk of cognitive decline.

MCI, characterized by subtle cognitive deficits that do not significantly impact daily functioning, affects a substantial portion of the elderly population in China. Epidemiological investigations have shown that the prevalence of MCI among urban Chinese adults aged 60 and 65 is 15.5% and 20%, respectively, with approximately one-third of these individuals progressing to dementia. 

The study, led by a team of dedicated physicians, recruited 750 participants aged 65 and above who underwent cognitive assessments using the Montreal Cognitive Assessment (MoCA) and Clinical Dementia Rating (CDR) scales. Among them, 550 individuals voluntarily underwent blood examinations, which revealed a significant association between increased RDW and MCI.

Interestingly, the study also found that female gender and low education levels were risk factors for MCI. This finding aligns with previous evidence suggesting that the sex-specific pathophysiological mechanisms behind AD risk are influenced by the menopause transition, a midlife neuroendocrine transition state unique to females. Additionally, years of education have been linked to the prevalence of MCI in prior studies.

Further analysis of the cognitive domains assessed by MoCA revealed that RDW was negatively correlated with scores in all domains, with the strongest correlation observed for attention. This finding suggests that attention impairment could serve as a sensitive marker for MCI, a notion supported by binary regression analysis showing that impaired attention had the greatest weight among the cognitive domains in MCI.

The study’s findings have significant implications for the early detection and management of cognitive impairment. RDW, a readily available and inexpensive hematologic measure, could offer valuable insights into an individual’s risk of developing MCI and, potentially, AD. By identifying those at risk early on, healthcare professionals can implement targeted interventions and support strategies to mitigate cognitive decline and improve quality of life.

Reference

Yang, Juan; Sui, Haijing; Song, Haihan; Jiao, Ronghong; Zhao, Xiaohui.

Red Cell Distribution Width is Related to Mild Cognitive Impairment: A Cross-Sectional Study of Community Residents. Neurology India 72(1):p 64-68, Jan–Feb 2024.

DOI: 10.4103/ni.ni_211_22

Canada: A recent population-based cohort study of 2.2 million female teenagers showed that teen pregnancy may be a readily identifiable marker for subsequent risk of premature mortality in early adulthood. The findings were published online in JAMA Network Open on March 14, 2024.

The US Food and Drug Administration has cleared first transcranial magnetic stimulation (TMS) device, NeuroStar, adjunct to first-line treatment of major depressive disorder for individuals aged 15 to 21.

NeuroStar is the first and only transcranial magnetic stimulation (TMS) treatment FDA-cleared for this age group, making it the fourth FDA-cleared indication for NeuroStar.

“The prevalence of depression in adolescents and young adults has been accelerating since the COVID-19 pandemic. The current treatment options available for adolescents are extremely limited, compared to those available for adults,” according to Dr. Kenneth Pages, Medical Director of TMS of South Tampa. “NeuroStar’s TMS therapy now offers a promising first-line treatment for adolescents, backed by real-world data and impressive response rates consistent with response rates for adults. This advancement has the potential to set a new treatment paradigm for how we address depression in our youth.”

The FDA’s decision to grant clearance for this new indication is based in part on analyzing real-world data collected through NeuroStar’s proprietary TrakStar® platform. This platform provided crucial insights into the treatment’s effectiveness and safety profile in adolescents. Among the 1,169 adolescents in the data analysis, 78% achieved clinically meaningful improvement in their depression severity. The FDA reviewed the comprehensive data set from TrakStar, along with clinical data from the published literature, and concluded that NeuroStar TMS was substantially equivalent in terms of safety and effectiveness when used as an adjunct to antidepressant therapy over antidepressant therapy alone in this population.

“Receiving FDA-clearance to treat the adolescent segment aged 15 and up is a treatment solution that is long overdue in the mental health industry,” said Keith J. Sullivan, President and CEO of Neuronetics. “We are excited to offer NeuroStar TMS therapy as a new option for young people and for their concerned parents who have struggled to find a treatment they can be confident in. As a company, we will be focused on driving even more awareness and education about NeuroStar given that this new clearance grows our total addressable market in MDD by 35%.”

NeuroStar is harnessing the versatility of its coil design, enabling providers to address the treatment needs of adolescents with MDD symptoms immediately, all without requiring additional hardware upgrades or purchases.

About Adolescent Depression

Adolescent depression is a complex and challenging mental health condition that affects young individuals during the crucial period of adolescence. An estimated 4.3 million U.S. adolescents aged 15-21 are affected by MDD. Depression amongst adolescents can disrupt crucial aspects of development, such as academic performance, relationships with peers and family members, and overall emotional well-being.

NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of MDD in adolescent patients aged 15-21.

The US Food and Drug Administration has approved sotatercept (Winrevair) for treatment of  pulmonary arterial hypertension (PAH) in  adults.

Sotatercept is a novel activin signaling inhibitor which increases exercise capacity and reduce the risk of clinical worsening events for people with WHO group 1 pulmonary hypertension.

WINREVAIR was previously granted Breakthrough Therapy Designation by the FDA. WINREVAIR is the first FDA-approved activin signaling inhibitor therapy for PAH, representing a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH.

“Pulmonary arterial hypertension is a rare, progressive and ultimately life-threatening disease in which blood vessels in the lungs thicken and narrow, causing significant strain on the heart,” said Dr. Marc Humbert, Professor of Medicine and Director of the Pulmonary Hypertension Reference Center at the Université Paris-Saclay and investigator on the Phase 3 STELLAR study. “Based on the Phase 3 STELLAR trial, adding WINREVAIR to background PAH therapy demonstrated significant clinical benefits compared to background PAH therapy alone. This approval is an important milestone, as it offers healthcare providers a novel therapeutic option that targets a new PAH treatment pathway.”

The approval is based on the Phase 3 STELLAR trial, which compared WINREVAIR (n=163) to placebo (n=160), both in combination with background standard of care therapies in adult patients with PAH (WHO Group 1 FC II or III). Results showed adding WINREVAIR to background therapy increased six-minute walk distance from baseline by 41 meters (95% CI: 28, 54; p<0.001; placebo-adjusted) at Week 24 and significantly improved multiple important secondary outcome measures, including reducing the risk of death from any cause or PAH clinical worsening events by 84% versus background therapy alone (number of events: 9 vs 42, hazard ratio=0.16; 95% CI: 0.08, 0.35; p<0.001).

Healthcare providers should monitor hemoglobin and platelets before each dose of WINREVAIR for the first 5 doses, or longer if values are unstable, and periodically thereafter to determine if dose adjustments are required. WINREVAIR may increase hemoglobin and may lead to erythrocytosis, which if severe may increase the risk of thromboembolic events or hyperviscosity syndrome. WINREVAIR also may decrease platelet count and lead to severe thrombocytopenia, which may increase the risk of bleeding; thrombocytopenia occurred more frequently in patients also receiving prostacyclin infusion. Treatment should not be initiated if platelet count is <50,000/mm3. See additional Selected Safety Information below.

“The Pulmonary Hypertension Association welcomes the development of new therapies for those with PAH,” said Matt Granato, president and chief executive officer, Pulmonary Hypertension Association. “A diagnosis of PAH is a life-changing experience for patients and families due to its chronic, progressive nature. Patients with PAH experience limiting symptoms such as shortness of breath and fatigue. We are excited to see industry research leading to a better understanding of PAH and the development of a medicine in a novel treatment pathway that expands options for the patient community.”

“New treatment options continue to be needed for patients with pulmonary arterial hypertension that support important clinical goals, including increasing exercise capacity and improving functional class,” said Dr. Aaron Waxman, Executive Director of the Center for Pulmonary Heart Diseases at Brigham and Women’s Hospital and investigator on the Phase 3 STELLAR study. “Sotatercept added to background therapy has the potential to become a new standard of care option for patients with pulmonary arterial hypertension.”

WINREVAIR is given once every three weeks by subcutaneous injection and may be administered by appropriate patients or caregivers with guidance, training and follow-up from a healthcare provider. Healthcare providers and patients/caregivers should refer to the Instructions for Use for information on the proper preparation and administration of WINREVAIR. Merck estimates that WINREVAIR will be available for dispensing by select specialty pharmacies in the U.S. by the end of April.

“PAH remains a debilitating disease with high morbidity and mortality,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “This approval of WINREVAIR is an important milestone and a testament to our science-led strategy and focus on the development of innovations that can help people affected by rare diseases like PAH. We are proud to bring this novel medicine to patients.”

Merck offers support to patients who are prescribed WINREVAIR, including information about insurance coverage and help for eligible patients with out-of-pocket costs and co-pay assistance options, through the Merck Access Program.