Search Results for “Alzheimer's” – Page 2 – media

Bodybuilding supplement may help stave off progression of Alzheimer’s

by Rush University Medical Center Graphical abstract. Credit: Cell Reports (2023). DOI: 10.1016/j.celrep.2023.112717 RUSH researchers recently discovered that a muscle-building supplement called beta-hydroxy beta-methylbutyrate, also called HMB, may help protect memory, reduce plaques and ultimately help prevent the progression of Alzheimer’s disease. Results from the study were published in Cell Reports. HMB is not a prescription drug or a steroid, but an over-the-counter supplement that is available in sports and fitness stores. Bodybuilders regularly use HMB to increase exercise-induced gains in muscle size and strength while improving exercise performance. HMB is considered safe even after long-term use, with no known side effects. “This may be one of the safest and the easiest approaches to halt disease progression and protect memory in Alzheimer’s disease patients,” said Kalipada Pahan, Ph.D., the Floyd A. Davis, MD, Professor of Neurology and professor of neurological sciences, biochemistry and pharmacology at RUSH Medical College. Reduces plaques ...
- Source: drugdu
- 115
- July 22, 2023
Eisai, Biogen’s Leqembi May Face Rollout Hurdles Now, but Experts Still Like the Alzheimer’s Drug

After a full FDA approval last week triggered Medicare coverage of Eisai and Biogen’s Leqembi, doctors are still trying to work out the logistics of testing and reimbursement. But at least two experts remain positive about the drug’s efficacy and safety profile.The new Leqembi label carries a boxed warning about the risks of brain bleeding and swelling known as amyloid-related imaging abnormalities (ARIA). But two Alzheimer’s opinion leaders suggested the side effect is manageable typically by extensive monitoring in the first six months, Leerink Partners analysts said in a Wednesday note. But the two experts were split on whether they intend to treat patients with the ApoE ε4 genetic trait. The FDA label requires testing for that biomarker before initiating Leqembi to inform the risk of ARIA. While one expert felt comfortable giving Leqembi to APOE4 carriers as long as the patients are informed of the risk, the other ...
- Source: drugdu
- 101
- July 15, 2023
New program offers hiking adventures for people with younger-onset Alzheimer’s

Starting this July, people diagnosed with Alzheimer’s before age 65 will have a new opportunity to connect with others while exploring the great outdoors through a program called SOAR. The name is an acronym for Shared Outdoor Adventures for Resilience. Offered by the UW Medicine Memory and Brain Wellness Center, SOAR will feature free monthly hikes in the Puget Sound area for small groups of people with younger-onset Alzheimer’s. Each participant brings along a family member or friend. A lifelong recreation specialist from Seattle Parks and Recreation will lead the hikes. Optional transportation is provided. Hikes will be up to 3 or 4 miles. The type of terrain will vary among the different hikes to provide a challenge but still be accessible to a wide range of participants. Volunteer naturalists will join periodically to talk about plants and animals in the region. SOAR will conclude with a nature retreat at ...
- Source: drugdu
- 115
- July 10, 2023
With full Alzheimer’s approval in hand, Eisai and Biogen kick off Leqembi’s launch in earnest

It’s official: Roughly half a year after the FDA granted an accelerated nod to Eisai and Biogen’s new Alzheimer’s disease med lecanemab, the companies have converted that green light into a full-fledged, traditional approval. Now, the drug—also known as Leqembi—is set to unshackle itself from a strict coverage determination by the Centers for Medicare & Medicaid services (CMS). With a full approval in hand, Leqembi has become the first treatment shown to reduce the rate of disease progression and slow cognitive and functional decline in adults with Alzheimer’s under the traditional approval pathway, Eisai Executive Vice President Alex Scott, who oversees government affairs, said in an interview. Those benefits stand across a “broad patient group that’s generalizable to the whole Medicare population,” he added. Leqembi won an accelerated FDA approval in January based on its ability to reduce amyloid beta plaque, a marker of Alzheimer’s disease that’s believed to be ...
- Source: drugdu
- 110
- July 8, 2023
Missed trial protocols, fabricated emails and failed endpoint mar BioXCel’s Alzheimer’s agitation readout

A new treatment for Alzheimer’s disease agitation episodes might be on the horizon, but a principal trial investigator skirting protocol could muddy the waters. As BioXCel unveiled its phase 3 data for its orally dissolving dexmedetomidine (originally Pfizer’s Precedex) formulation in Alzheimer’s-related agitation, the company also disclosed some serious trial missteps in an Securities and Exchange Commission (SEC) filing. After the FDA in December inspected a trial site that enrolled about 40% of study participants, the agency found three big red flags relating to adherence of the trial’s framework, the filing says. For one, the investigator failed to follow the informed consent plan for four trial subjects, chief medical officer Robert Risinger, M.D., told investors on a conference call. In “certain instances” the investigative plan wasn’t followed and sufficient case histories weren’t maintained for some patients. For example, the site reported a serious adverse event for one patient outside of ...
- Source: drugdu
- 105
- July 2, 2023
Eisai, Biogen’s Alzheimer’s disease drug Leqembi passes muster at FDA adcomm

After a daylong discussion among experts on an FDA advisory committee, Eisai and Biogen’s Leqembi is heading into the final stretch of its regulatory review on strong footing.During a Friday meeting, members of the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee took a careful look at the data behind the partners’ Alzheimer’s disease drug. Ultimately, the group voted 6 to 0 that the drug’s Clarity AD study verify its clinical benefit. In the discussion portion of the meeting, advisory committee members described the trial results as “robust,” “meaningful,” “consistent” and “significant.” Now, it’s up to the FDA to decide whether to follow the advisory committee’s guidance. The agency is expected to decide on the application by July 5. Before the Friday discussion, the FDA released its own briefing document that appeared to outline agency support for a full approval. During the meeting, the FDA’s acting director of the ...
- Source: drugdu
- 111
- June 13, 2023
Researchers discover novel ‘Shanghai APP’ mutation in late-onset Alzheimer’s disease

Alzheimer’s disease (AD) is a progressive neurodegenerative disorder affecting tens of millions of people worldwide, and it is the most common cause of dementia. Early-onset AD is typically associated with mutations in the genes APP, PSEN1, and PSEN2, leading to a more aggressive form of the disease with atypical symptoms. In contrast, the newly discovered “Shanghai APP” mutation has been linked to LOAD, which affects a larger population of AD patients. In a study published in Genes & Diseases, researchers from Ruijin Hospital, affiliated to Shanghai Jiao Tong University School of Medicine and other three teams detected the Shanghai APP mutation in a Chinese patient who developed memory decline in his mid-70s. Neuroimaging techniques confirmed the presence of widespread amyloid β deposition, a key hallmark of AD. Using molecular dynamics simulation and in vitro experiments, the team found that the E674Q mutation led to increased processing of APP and production of amyloid β, ...
- Source: drugdu
- 147
- May 16, 2023
Otsuka, Lundbeck’s Rexulti nabs new use in Alzheimer’s disease agitation

After Lundbeck and Otsuka’s Rexulti cleared a key advisory committee hurdle, the FDA has given the drug the go-ahead to treat dementia-associated agitation in Alzheimer’s disease patients With the approval, Rexulti becomes the first drug approved for this use in the United States. The FDA granted the nod based on data from two 12-week studies in which patients showered statistically significant and clinically meaningful improvements on the Cohen-Mansfield Agitation Inventory scale, according to the FDA. The metric looks at the frequency and intensity of dementia-related agitation. In the studies, Rexulti demonstrated a 31% improvement from baseline agitation symptoms compared with placebo. Agitation symptoms cover a wide group of behaviors including pacing, gesturing, profanity, shouting, and physical outbursts, Otsuka said in a release. The symptoms are the leading causes of assisted living or nursing room placement and have been known to be associated with accelerated disease progression, Tiffany Farchione, director ...
- Source: drugdu
- 111
- May 13, 2023
Spherix

U.S. neurologists are “cautiously optimistic” about using Eisai’s Leqembi in Alzheimer’s disease as concerns about safety and the need for the FDA’s full green light for the drug remain high barriers to uptake. That’s according to a new survey and report out by drug launch analyst Spherix Global Insights, which in March asked 73 neurologists working in the U.S. about their use and receptivity of Leqembi, which was partially approved by the FDA at the start of the year. Now launched, the drug finds itself at a strange junction. It still does not have a full FDA approval; that isn’t set to come until early July. While there is another new drug on the market for Alzheimer’s—namely Aduhelm, which Eisai helped create with Biogen—that drug is commercially dead in the water. The Centers for Medicare & Medicaid Services (CMS) refused to cover payments of Aduhelm, which was ...
- Source: drugdu
- 132
- April 14, 2023
FDA Grants Breakthrough Therapy Designation to Pfizer’s Investigational Alzheimer’s Disease Treatment

Pfizer, a global pharmaceutical company, has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to its investigational treatment for Alzheimer’s disease, called PF-05217917. This designation is intended to accelerate the development and review of promising drugs that have the potential to address serious or life-threatening conditions. Alzheimer’s disease is a progressive brain disorder that affects millions of people worldwide, causing memory loss and other cognitive impairments. There are currently no approved treatments that can slow or stop the progression of the disease. Pfizer’s PF-05217917 is an antibody that targets the tau protein, which is believed to play a key role in the development and progression of Alzheimer’s disease. The FDA’s decision to grant Breakthrough Therapy designation to PF-05217917 was based on the results of a Phase 2 clinical trial that involved patients with mild to moderate Alzheimer’s disease. The trial showed that ...
- Source: drugdu
- 250
- March 22, 2023

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