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Time of India
an hour ago
- Time of India
What is Leqembi? The first Alzheimer's treatment approved today in Saudi Arabia
Leqembi targets beta-amyloid plaques in the brain, aiming to slow Alzheimer's progression in patients with mild cognitive impairment The Saudi Food and Drug Authority (SFDA) announced today the official approval of Leqembi, the first Alzheimer's treatment available in Saudi Arabia. This approval marks a significant milestone in addressing Alzheimer's, a progressive brain disorder that affects memory and thinking skills. Leqembi is specifically indicated for patients experiencing mild cognitive impairment or mild dementia caused by Alzheimer's, who have either no copies or just one copy of a particular gene variant known as apolipoprotein E4 (ApoE4). How Leqembi Works: Targeting the Root Cause Leqembi represents an innovative approach to treating Alzheimer's. Unlike many existing therapies that only ease symptoms, this drug aims to slow the actual progression of the disease. It is a biologic therapy developed using monoclonal antibody technology, a sophisticated method that creates lab-produced molecules designed to target specific proteins in the body. In this case, Leqembi works by targeting beta-amyloid proteins, which tend to build up in the brains of Alzheimer's patients and form sticky clumps called plaques. These plaques are widely believed to contribute to the cognitive decline seen in the disease. by Taboola by Taboola Sponsored Links Sponsored Links Promoted Links Promoted Links You May Like Patrocinio: Unsold Furniture Liquidation 2024 (Prices May Surprise You) Unsold Furniture | Search Ads Learn More Undo Specifically, brain plaques, known as amyloid plaques, are abnormal clumps of protein fragments called beta-amyloid that build up in the brain, especially in people with Alzheimer's. These plaques interfere with the normal communication between nerve cells (neurons), disrupting brain function. By helping reduce the formation of these harmful plaques, Leqembi seeks to protect brain function and slow cognitive decline over time. The treatment is given through an intravenous infusion every two weeks, allowing the drug to circulate and act within the brain. Proven Effectiveness Backed by Clinical Studies Before approving Leqembi, the SFDA thoroughly reviewed evidence of its safety, effectiveness, quality, and compliance with regulatory standards. Clinical trials revealed that Leqembi significantly slows the progression of Alzheimer's disease compared to a placebo. The effectiveness was measured using established clinical scales that assess memory, thinking, and daily functioning abilities. However, like all medications, Leqembi can cause side effects. The most commonly reported include: Headaches Reactions related to the infusion process Amyloid-related imaging abnormalities (ARIA), a term that refers to unusual changes detected in brain MRI scans. These abnormalities may include swelling (cerebral edema) or tiny brain bleeds (microhemorrhages). Because ARIA can only be detected through brain scans, careful monitoring is essential throughout treatment. Safety First: The Need for Careful Patient Monitoring The SFDA stresses the importance of ongoing patient monitoring during treatment. Before starting Leqembi, patients must be tested for their ApoE4 gene status, as this influences the risk of side effects. Those with two copies of the ApoE4 gene are not currently eligible for the treatment due to a higher likelihood of complications. Additionally, the pharmaceutical company responsible for Leqembi is required to track how the drug performs once it is in use (post-marketing surveillance). They must regularly submit updated reports on safety and effectiveness to the SFDA. A comprehensive risk management plan is also mandatory to ensure the treatment is used safely and responsibly. Advancing Healthcare with Biotechnology in Saudi Arabia The approval of Leqembi reflects the SFDA's commitment to expanding access to advanced and high-quality medical treatments, especially those developed through cutting-edge biotechnological methods. Biotech therapies like Leqembi represent a rapidly growing field in medicine, offering new hope for diseases that previously had limited treatment options. About the SFDA Established in 2003 under the Council of Ministers' resolution, the Saudi Food and Drug Authority is an independent regulatory body directly reporting to the President of the Council of Ministers. Its main mission is to safeguard public health by ensuring the safety and quality of food, medicines, biological and chemical substances, medical devices, and cosmetics. The SFDA oversees all procedures related to these products, aiming to protect both human and animal health throughout the Kingdom.
7NEWS
an hour ago
- 7NEWS
Worried about Alzheimer's? Start walking, according to a new 10-year study
If you needed another reason to get your daily steps in, science just handed you one. A new study shows that walking daily can reduce the risk of cognitive decline — especially among those with a genetic predisposition for Alzheimer's disease. Almost 3000 participants between the ages of 70 and 79 reported their daily walking habits over the course of 10 years, according to research presented on Tuesday at the annual Alzheimer's Association International Conference. Those who reported maintaining or increasing their walking habits over the years showed greater improvements in processing speed and executive function. The benefits of walking were especially noticeable among those with a genetic predisposition for developing Alzheimer's disease, according to the preprint, which has not been peer-reviewed or published in a professional journal. 'We know sedentary behaviour increases as you get older, and physical activity decreases,' said senior study author Cindy Barha, an assistant professor of kinesiology at the University of Calgary in Alberta. 'So we recommend reducing your sedentary behaviour by introducing small bouts of walking in between those times you have to be sitting down.' How does Alzheimer's disease work? Alzheimer's disease is a severe form of dementia thought to be caused by a build-up of harmful plaques in the brain that interfere with how the nerve cells communicate, eventually leading to their death, Barha said. As more nerve cells die, people with Alzheimer's can develop progressive memory loss, confusion, personality changes and physical decline. Eventually, the disease can be fatal, and there is no known cure. Genetics are thought to play a major role in the disease. Specifically, genotypes called APOE affect the metabolism of plaque and other fats throughout the bloodstream. One specific kind, APOE4, is known to make it harder for the brain to clear the plaques and is linked to a higher risk of cognitive decline. About 15 to 25 per cent of people have this version of the APOE gene, and the only way to find out is from a genetic test, according to data from the US National Institutes of Health. The mind-body connection Although the new study did not test a uniform walking regimen, Barha suggests walking multiple times daily to break up sedentary behaviour and maintaining consistent walking habits year to year to prevent cognitive decline. 'More research is really needed to determine how many steps that really takes, but more is definitely going to be better,' she said. 'The next steps would be to actually try to figure out the minimum amount of walking for different subgroups, (such as) females versus males, APOE4 carriers versus non-carriers.' A 2022 study found that even people who walked about 3800 steps per day at any speed cut their risk of dementia by 25 per cent. What might be going on between the brain and the rest of the body? Experts have several theories. For one, regular exercise has been shown to help the body produce more of a protein called brain-derived neurotrophic factor, or BDNF, which is like fertiliser for your brain, helping it grow more cells and form new connections, Barha explained. 'We're thinking there's proteins released from the muscle that travel to the brain and, either across the blood-brain barrier or at the blood-brain barrier, start a reaction that eventually leads to increases in BDNF within the brain,' she said. Another theory is that exercise reduces neuroinflammation, a common symptom of Alzheimer's disease. The brain sends immune cells called microglia to attack plaque build-up, but this can backfire, explained Christiane Wrann, an associate professor of medicine at the Cardiovascular Research Center at Massachusetts General Hospital and Harvard Medical School. Chronic inflammation can lead microglia to begin attacking healthy brain cells as well, damaging the brain's connections. 'If you exercise, you actually strengthen the gene expression program that microglia need to function properly,' Wrann said. Does greater risk mean greater reward? The researchers were surprised to find that walking provided the greatest benefit to those with the APOE4 gene compared to those without it. To understand why this is, more research will be needed — but Barha has a theory. 'Before the study started, we think APOE4 carriers had more room to grow in terms of cognition, since they may already have been experiencing some cognitive decline,' she said. 'They also have more room to show improvement.' It's possible that the study itself also motivated participants with APOE4 genes to walk more than they had been beforehand, slowing their rate of decline. 'This is a very strong example (that) it's never too late to start exercising,' Wrann said. 'Every step counts, and it's much better to do an exercise regimen that you actually like, that you can actually stick to.'
Saudi Gazette
an hour ago
- Saudi Gazette
Saudi Arabia approves first Alzheimer's treatment with lecanemab for early-stage patients
Saudi Gazette report RIYADH — The Saudi Food and Drug Authority (SFDA) has officially approved the registration of lecanemab (Leqembi) for the treatment of patients with early-stage Alzheimer's disease, specifically those with mild cognitive impairment or mild dementia, who carry no copies or just one copy of the ApoE4 gene variant. This marks the first approved Alzheimer's treatment in the Kingdom. In a statement, the SFDA noted that lecanemab is a biologic drug based on monoclonal antibody technology, and is the first biologic therapy licensed for Alzheimer's in Saudi Arabia. The treatment works by targeting amyloid beta protein plaques in the brain, a hallmark of Alzheimer's pathology, thereby helping slow cognitive decline. The drug is administered via intravenous infusion every two weeks. The authority said the approval followed a comprehensive evaluation of the drug's efficacy, safety, and quality, with clinical trials showing that lecanemab slows the progression of symptoms compared to placebo, based on established Alzheimer's disease assessment scales. The most commonly reported side effects included headaches, infusion-related reactions, and amyloid-related imaging abnormalities (ARIA) — brain changes detectable via MRI that may involve brain swelling or microbleeds. The SFDA emphasized the importance of ongoing patient monitoring during treatment, particularly for any emerging side effects. Genetic testing is required before initiating therapy to assess patient eligibility and reduce risk of adverse reactions. The authority also required the manufacturer to submit regular post-marketing reports on the drug's effectiveness and safety, and to implement a risk management plan to ensure the treatment's optimal and safe use.
