Latest news with #SHINE
Yahoo
16-07-2025
- Health
- Yahoo
Cognition Therapeutics' Positive Clinical Data from Zervimesine (CT1812) Phase 2 Study in Dementia with Lewy Bodies (DLB) will be Presented in a Podium Presentation at AAIC
- Zervimesine-treated participants tested 86% better on behavioral outcomes (NPI 12), 52% on activities of daily living, 91% on cognitive fluctuations, and 62% on motor symptoms as compared to placebo - - Additional presentations highlight positive clinical and biomarker effects of zervimesine in the low p-tau217 population in Phase 2 Alzheimer's disease study - PURCHASE, N.Y., July 16, 2025 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc., (the Company or Cognition) (NASDAQ: CGTX), a clinical stage company developing drugs that treat neurodegenerative disorders, announced that James E. Galvin, MD, MPH will present results from the Phase 2 'SHIMMER' study of zervimesine (CT1812) in dementia with Lewy bodies (DLB) during an oral presentation at the Alzheimer's Association International Conference (AAIC). Dr. Galvin is director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and was the COG1201 SHIMMER study (NCT05225415) director. The presentation will take place on July 29, 2025 in the 8:00 a.m. ET Featured Research Session. 'The results of the Phase 2 SHIMMER study give hope to the millions of people living with DLB and their healthcare teams, who struggle to treat this complex disease,' stated Dr. Galvin. 'My colleagues and I believe that there is great potential in a once-daily oral medication that slows disease progress while simultaneously reducing the severity and frequency of some of the most troublesome symptoms of DLB.' DLB is the second most common cause of dementia, affecting approximately 1.4 million Americans. People living with DLB experience a variety of symptoms, which typically include neuropsychiatric features such as hallucinations, delusions and agitation; cognitive impairment; Parkinsonian movement disorders; REM sleep behavior disorder; and fluctuations in attention and awareness. Currently no disease-modifying therapeutics are approved for DLB. Anthony Caggiano, MD, PhD, Cognition's CMO and head of R&D added, 'Zervimesine's broad neuroprotective mechanism is illustrated by the favorable results observed in the Phase 2 SHIMMER study in DLB. In the SHIMMER study, zervimesine treatment slowed the progression of DLB's diverse symptomology, with a meaningful impact on neuropsychiatric, motor, functional, and cognitive measures. Results from the Phase 2 'SHINE' study in people with Alzheimer's disease add further evidence to zervimesine's neuroprotective properties. We look forward to presenting results from both studies at AAIC.' The SHINE study was a signal-finding trial that showed zervimesine treatment preserved cognitive and functional abilities better than placebo in people with mild-to-moderate Alzheimer's disease. This impact was more robust in participants with lower levels of p-Tau217, who experienced a 95% slowing of cognitive decline at six months as measured by ADAS-Cog 11 compared to placebo. Cognition will present clinical efficacy results and new proteomic findings from this Alzheimer's study at AAIC. Dr. Galvin's slide presentation as well as Cognition's three posters will be available on the Cognition Therapeutics website in accordance with the conference's embargo policy. Cognition at AAIC: Featured Research Session: • Baseline Characteristics and Results of the Phase 2 COG1201 SHIMMER Study of Zervimesine (CT1812): 8:00-8:45 a.m. on July 29 Posters: • Zervimesine (CT1812) Treatment Benefits Patients with Lower Baseline Plasma p-tau217 Across the Mild-to-Moderate AD Spectrum: (#106858) July 27 • Exploratory CSF proteomic analysis of a pre-specified pTau217 subgroup from the SHINE clinical trial identifies biomarkers correlated with cognitive improvement in Alzheimer's disease patients treated with zervimesine: (#102120) July 27 • An exploratory proteomics plasma biomarker analysis of the SHIMMER Phase 2 clinical trial to assess the pharmacodynamic effect of the sigma-2 receptor modulator zervimesine in dementia with Lewy bodies patients: (#106855) July 27 About the SHIMMER Study in Dementia with Lewy BodiesThe SHIMMER study (COG1201; NCT05225415) is an exploratory double-blind, placebo-controlled Phase 2 clinical trial that enrolled 130 adults with mild-to-moderate DLB, who were randomized to either daily oral doses of zervimesine (100 mg or 300 mg) or placebo for six months. A total of 88 participants were randomized to the two treatment arms and 42 to the placebo arm. Assessments were conducted throughout the study using a number of tools, including the Neuropsychiatric Inventory (NPI) to measure changes in hallucinations, anxiety and delusions; the Clinician Assessment of Fluctuation (CAF) to measure the frequency and duration of cognitive fluctuations; the Montreal Cognitive Assessment (MoCA) and Cognitive Drug Research Battery (CDR), which track cognitive performance; and the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, an objective assessment of parkinsonism. The SHIMMER study is supported by a grant award from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million (R01AG071643) and was conducted in collaboration with James E. Galvin, MD, MPH, director of the Comprehensive Center for Brain Health at the University of Miami Miller School of Medicine and the Lewy Body Dementia Association (LBDA). About the SHINE Study in Mild-to-Moderate Alzheimer's Disease The SHINE study (NCT03507790) is a double-blind, placebo-controlled Phase 2 signal-finding trial that enrolled 153 adults with mild-to-moderate Alzheimer's disease who were evenly randomized to receive either placebo or one of two doses of CT1812 (100 mg or 300 mg), which was taken orally daily for six months. The primary endpoint was safety and tolerability. The key secondary endpoint of cognition was ADAS-Cog 11. Exploratory endpoints included change in MMSE, ADAS-Cog 13, ADCS-ADL and -CGIC as well as pre-specified subgroup analyses included a comparison of cognitive and functional changes in participants with plasma p-tau217 levels above and below the median. The SHINE study was supported by two grant awards from the National Institute on Aging of the National Institutes of Health (NIH) totaling approximately $30 million. About Zervimesine (CT1812)Zervimesine (CT1812) is an investigational, oral, once-daily pill in development for the treatment of CNS diseases such as Alzheimer's disease and dementia with Lewy bodies (DLB). While these diseases have different symptoms, both are associated with the buildup of certain proteins in the brain – Aβ and ɑ-synuclein. As these proteins bind to neurons, they can damage and ultimately destroy the neurons. This results in a progressive loss in a person's ability to learn, recall memories, move efficiently, or communicate. These diseases progress relentlessly and ultimately result in death. If zervimesine can interrupt the toxic effects of these proteins, it may be able to slow progression of disease and improve the lives of those suffering from Alzheimer's and DLB. Zervimesine has been generally well tolerated in clinical studies to date. Zervimesine has been granted FDA Fast Track designation in Alzheimer's disease. The USAN Council has adopted zervimesine as the United States Adopted Name (USAN) for CT1812. About Cognition Therapeutics, Therapeutics, Inc., is a clinical-stage biopharmaceutical company discovering and developing innovative, small molecule therapeutics targeting age-related degenerative disorders of the central nervous system and retina. We currently are investigating our lead candidate, zervimesine (CT1812), in clinical programs in dementia with Lewy bodies (DLB) and Alzheimer's disease, including the ongoing START study (NCT05531656) in early Alzheimer's disease. We believe zervimesine and our pipeline of σ-2 receptor modulators can regulate pathways that are impaired in these diseases that are functionally distinct from other approaches for the treatment of degenerative diseases. More about Cognition Therapeutics and our pipeline can be found at Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. All statements contained in this press release or made during the conference, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding our product candidates, including zervimesine (CT1812), and any expected or implied benefits or results, including that initial clinical results observed with respect to zervimesine will be replicated in later trials and our future clinical development plans, and statements regarding our clinical trials of zervimesine and any analyses of the results therefrom, are forward-looking statements. These statements, including statements relating to the timing and expected results of our clinical trials involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as 'may,' 'might,' 'will,' 'should,' 'expect,' 'plan,' 'aim,' 'seek,' 'anticipate,' 'could,' 'intend,' 'target,' 'project,' 'contemplate,' 'believe,' 'estimate,' 'predict,' 'forecast,' 'potential' or 'continue' or the negative of these terms or other similar expressions. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: competition; our ability to secure new (and retain existing) grant funding; our ability to grow and manage growth, maintain relationships with suppliers and retain our management and key employees; our ability to successfully advance our current and future product candidates through development activities, preclinical studies and clinical trials and costs related thereto; uncertainties inherent in the results of preliminary data, pre-clinical studies and earlier-stage clinical trials being predictive of the results of early or later-stage clinical trials; the timing, scope and likelihood of regulatory filings and approvals, including regulatory approval of our product candidates; changes in applicable laws or regulations; the possibility that the we may be adversely affected by other economic, business or competitive factors, including ongoing economic uncertainty; our estimates of expenses and profitability; the evolution of the markets in which we compete; our ability to implement our strategic initiatives and continue to innovate our existing products; our ability to defend our intellectual property; the impacts of ongoing global and regional conflicts on our business, supply chain and labor force; our ability to maintain the listing of our common stock on the Nasdaq Capital Market; and the risks and uncertainties described more fully in the 'Risk Factors' section of our annual and quarterly reports filed with the Securities & Exchange Commission and are available at These risks are not exhaustive and we face both known and unknown risks. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, we operate in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that we may face. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Contact Information:Cognition Therapeutics, Casey McDonald (media)Tiberend Strategic Advisors, Mike Moyer (investors)LifeSci Advisorsmmoyer@ This press release was published by a CLEAR® Verified individual.
Time of India
21-06-2025
- Health
- Time of India
BMC squads destroy 50kg stale food in eateries
1 2 3 Bhubaneswar: Food inspection squads of the Bhubaneswar Municipal Corporation (BMC) on Saturday destroyed 50 kg of stale and contaminated food during checking of several hotels and restaurants in the city. The drive was carried out in view of jaundice and diarrhoea cases being reported from several areas. The inspection was carried out at Chandrasekharpur and IRC Village, from where multiple samples were taken for laboratory testing. Some food items, which had gone stale and were stored in unhygienic conditions were destroyed. "The surprise food quality inspection has been on since diarrhoea cases were reported in the city and it will continue. On Saturday, a penalty of Rs 8,000 was imposed on three hotels. They were warned not to serve stale food. If the hotels repeat the practice of serving stale food, they will be slapped with closure notices along with a penalty," said designated food safety officer Satyajit Patel. The Sanitation and Hygiene Inspection for Neat Environment (SHINE) team and food enforcement squad of BMC are carrying out the inspections. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Memperdagangkan CFD Emas dengan salah satu spread terendah? IC Markets Mendaftar Undo The SHINE team was formed in Aug last year to provide more teeth to sanitation enforcement. Earlier, the inspection teams checked eateries at Unit I, Unit II, Rasulgarh and Palasuni areas. "We want to ensure that the vendors don't keep stale food for the next day. The usual practice is leftover food on a given day (till night) is kept to be mixed up with freshly cooked food. This makes them unhygienic," Patel added. Food safety squads said fast food items and some local delicacies are mostly dumped at the source itself. "So far bacterial contamination has been detected in three food samples. Now, we will randomly check panipuri (gupchup) and dahi bara-aludam stalls to find out if the water they use is contaminated," Patel said. Laboratory tests also ascertain if any colour and preservatives that are not permissible in food are used. BMC officials said there are some shops, including eateries, which mostly carry out their business in the evening. Hence, the SHINE team has been asked to move around the eateries in the evening as well.
Irish Examiner
10-06-2025
- Health
- Irish Examiner
Charity hits out at 'fundamentally inaccurate' warnings about draft Mental Health Bill
A row has broken out over the impact of the draft Mental Health Bill with the national charity SHINE saying warnings of negative impacts are 'fundamentally inaccurate'. The draft bill was published last year to much concern from psychiatrists and will be discussed at the first sitting of the Oireachtas Health Committee on Wednesday. The Irish Medical Organisation (IMO) is expected to criticise criteria for involuntary admission, timing of patients' psychosocial assessment, and care plan regulations. Professor Matthew Sadlier, a psychiatrist and chair of the IMO consultants committee, is due to say: 'Effectively, where a patient is found to lack capacity to consent to treatment, the bill would lead to a situation where rather than treating patients, consultants will be required to make an application to the High Court to get permission to do so.' He is expected to warn that patients with serious mental illness could be denied 'the right to timely and often life-saving medical treatment'. He is also due to discuss the practicalities of the proposals and is expected to say, while around 760 psychiatrists are needed, Ireland only has 570 approved posts, with almost 30% unfilled or filled on a temporary basis. However SHINE CEO, Nicola Byrne, has raised concerns about 'deeply stigmatising language and worrying predictions' used in discussions over the last few months. 'Claims that the bill abandons individuals with severe mental illness or removes the ability to intervene when someone is unwell and lacks the capacity to understand their situation or the need for help are fundamentally inaccurate,' she said. "This legislation aims to provide a clearer, more rights-respecting framework for involuntary mental healthcare.' She defended the proposed admission criteria, saying: 'The legislation is designed to intervene when a mental disorder presents specific risks or urgent treatment needs.' There are already 'significant safeguards' in the Bill, she argued. 'What is too often missing from these discussions is the reality that the vast majority of people living with psychosis or schizophrenia are not in crisis, they are studying, working, parenting, volunteering, and contributing to their communities like anyone else,' she said. Read More Suzanne Crowe: People with severe mental illness will be failed by proposed new law
Daily Express
01-06-2025
- Business
- Daily Express
Over 450 Pulau Gaya residents benefit from HRD Corp outreach
Published on: Sunday, June 01, 2025 Published on: Sun, Jun 01, 2025 Text Size: Sim and others at the event. KOTA KINABALU: The Human Resources Ministry (Kesuma) and Human Resource Development Corporation (HRD Corp) have extended skills training and aid to over 450 residents of Pulau Gaya through the 'Sentuhan Kesuma bersama HRD Corp di Bawah Bayu' community outreach programme. Held in conjunction with National Training Week 2025, the event featured hands-on workshops in digital marketing, drop shipping, and floral entrepreneurship for women, youth, and students from Kampung Gaya, Lok Urai, Torong Logong and Kesuapan. Human Resources Minister Steven Sim Chee Keong said the ministry aims to reach 60,000 Sabahans with skills training this year, adding that national progress depends on equipping the people with better skills. HRD Corp also launched a strategic partnership with Universiti Malaysia Sabah (UMS) under the SHINE initiative to establish Malaysia's first lifelong learning hub focused on workforce development and research. The event also saw the launch of an Industrial and Community Training Centre and included RM36,000 in equipment support for local tourism training, alongside RM20,000 in PTA donations, food baskets, and 700 life jackets for islanders. * Follow us on our official WhatsApp channel and Telegram for breaking news alerts and key updates! * Do you have access to the Daily Express e-paper and online exclusive news? Check out subscription plans available. Stay up-to-date by following Daily Express's Telegram channel. Daily Express Malaysia
The Star
01-06-2025
- Business
- The Star
HRD Corp to train 60,000 in Sabah as govt ramps up upskilling for state, says Steven
KOTA KINABALU: The government is ramping up upskilling Sabahans this year, says Steven Sim, starting with HRD Corp's aims to train 60,000 people this year. The Human Resources Minister said this would be a fourfold increase from 15,000 participants in 2024. Speaking at a ministry event with HRD Corp in Pulau Gaya near here, Sim stressed that upskilling Malaysians, especially those in remote areas, is vital for individual empowerment and national development. 'We want every citizen to be equipped with skills that can help them earn a better income. When our people are skilled, the nation progresses too,' he said during the National Training Week (NTW) 2025 event on Sunday (June 1). 'Next week, HRD Corp will launch National Training Week 2025, and we will return to Pulau Gaya to train at least 5,000 residents,' he said. Over 450 residents from Kampung Gaya, Kampung Lok Urai, Kampung Torong Logong, and Kampung Kesuapan participated in the event, attending skills workshops focused on floral entrepreneurship, digital marketing, and dropshipping, alongside motivational talks for students. Sabah Industrial Development and Entrepreneurship Minister Datuk Phoong Jin Zhe, who also attended, said expanding access to training was key to unlocking employment opportunities and attracting major investments. 'Training like this does not just raise incomes, but also helps transform Sabah's economy and uplift communities,' he said. In line with long-term workforce development, HRD Corp also announced a strategic partnership with Universiti Malaysia Sabah (UMS) to establish Sabah Human Capital Initiatives and Nurturing Excellence (SHINE), Malaysia's first lifelong learning hub dedicated to research, training, and talent development tailored for Sabah. Deputy HRD Corp chairman Ahsim Jamat expressed hope that the SHINE model will set the standard for human capital development nationwide. The programme also saw the launch of the Industrial and Community Training Collaboration Centre, which included a RM36,000 boost in training equipment support under HRD Corp's Training Equipment and Facility Enhancement Scheme (ALAT) for local tourism industry players. Sim also presented several corporate social responsibility (CSR) contributions, including 700 life jackets for daily boat passengers, food baskets for 300 families, and a RM20,000 donation to the parent-teacher associations of SMK and SK Pulau Gaya. Also present were Kuching MP Dr Kelvin Yii, UMS registrar Luqman Ridha Anwar, and Jesselton University College president Professor Dr Chin Yuk Fong.
