Alzheimer's disease Archives - Page 2 of 3

MoCA offers certification on cognitive assessment for early Alzheimer’s detection

Online training and certification is available for the 30-question Montreal Cognitive Assessment (MoCA) used to detect the earliest stages of Alzheimer’s and other cognitive disorders.

“Our goal has always been to offer the most advanced screening tools for the earliest detection of cognitive disorders,” MoCA test inventor and neurologist Dr. Ziad Nasreddine said in a news release. “Research has shown additional training to be helpful in reducing common administration errors and improving standardization, which limits risks for clinicians and patients, and improves quality of care.”

The test, which usually takes about 10 minutes to complete, is available in paper and digital formats and is widely used in clinical, research, and senior care settings across the globe. MoCA said more than 500 peer-reviewed studies have shown its test to be more sensitive and accurate than other commonly used assessments, including the Mini-Mental Stat…

Athira Pharma shares update on its ACT-AD and LIFT-AD studies of Alzheimer’s candidate ATH-1017

Athira Pharma (NSDQ:ATHA) announced that its lead development candidate, ATH-1017, had balanced baseline characteristics to date in two ongoing late-stage Alzheimer’s studies.

Presenting the data at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston, the company’s chief medical officer Dr. Hans Moebius said that the baseline characteristics are consistent between the ACT-AD and LIFT-AD studies.

Athira expects topline data from the ACT-AD to be available in the first half of 2022.

ACT-AD is a six-month double-blind Phase 2 trial while LIFT-AD is a six-month double-blind Phase 2/3 study.

ATH-1017 is a subcutaneously delivered small molecule drug that can cross the blood-brain barrier. The drug is designed to improve the activity of the hepatocyte growth factor (HGF) and its receptor, MET. The levels of both HGF and MET tend to be reduced in Alzheimer’s patients.

The company’s Aβ- and tau-…

Roche’s amyloid-targeting gantenerumab wins breakthrough therapy designation for Azheimer’s

Roche (OTCQX: RHHBY) has announced that its investigational anti-amyloid beta antibody gantenerumab for Alzheimer’s disease received breakthrough therapy designation from FDA.

The agency has granted the status to a range of investigational Alzheimer’s, including lecanemab from Eisai and Biogen and donanemab from Eli Lilly. Biogen’s aducanumab had also received the designation before FDA approved it in June.

Clinical trial data has shown that gantenerumab significantly reduced brain amyloid plaque, which accumulates in the brains of people with Alzheimer’s.

The so-called amyloid hypothesis has led to the development of scores of failed experimental Alzheimer’s therapies. Biogen‘s (NSDQ:BIIB) aducanumab was the first to win FDA approval based on amyloid clearing.

Showing convincing evidence of cognitive improvement, however, has remained more elusive for drug developers. A Phase 3 trial of gantenerumab did no…

Report: Congressional committees have questions over Biogen’s Alzheimer’s drug

The FDA’s relationship with Biogen is under scrutiny following the controversial approval granted to the company’s Aduhelm Alzheimer’s drug.

According to a report from Endpoints News, the House Energy & Commerce and Oversight committee chairs issued a letter this week requesting that acting FDA Commissioner Dr. Janet Woodcock and the FDA provide very specific information by Sept. 16, having told the agency that the information “was helpful, but significant questions remain.”

Last month, the HHS Office of Inspector General said it would review FDA’s accelerated approval pathway following the controversy surrounding the agency’s approval of the Alzheimer’s drug Aduhelm (aducanumab) from Biogen and Eisai. FDA officials went on to defend the use of the accelerated approval pathway in correspondence in NEJM, arguing that amyloid reduction is a “reasonably likely” surrogate.

The committees requested information regarding the …

Could COVID-19 vaccines guard against dementia?

COVID-19 vaccines could potentially guard against dementia and Alzheimer’s disease, according to an op-ed in WSJ.

COVID-19 infection itself can lead to long-term cognitive decline in some individuals and can accelerate Alzheimer’s symptoms, concluded an Alzheimer’s Association study. An Alzheimer’s Research & Therapy echoed those findings.

Pointing to data suggesting that vaccinations against tetanus and flu lead to reduced Alzheimer’s incidence in seniors, the WSJ article notes that a systemic immune response from vaccines could lower brain inflammation and thus protect brain neurons.

The thesis is not new. For example, a 2001 study in the Canadian Medical Association Journal theorized that prior vaccination against diphtheria or tetanus, poliomyelitis and influenza could protect against Alzheimer’s disease.

And last July, the Alzheimer’s Association published a study making similar claims. Researchers have correlated flu and pneumonia vac…

Aducanumab continues to face scrutiny as Biogen aims to woo neurologists and Alzheimer’s patients

Given the demand for a potential disease-modifying therapy for the disease, early demand for Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) is considerable from patients. Many neurologists, however, continue to view the drug with skepticism.

Fewer than half of neurologists expect they will prescribe the drug in the first six months of availability, according to research from Spherix Global Insights.

Still, many neurologists are receiving a flood of queries about Aduhelm. “We’ve received a lot of inquiries from patients themselves, a lot more referrals from primary care doctors, geriatrics doctors, internal medicine doctors who actually have no idea what aducanumab is, and they just are referring a bunch of patients themselves,” said private-practice neurologist Dr. Roni Sharon in a briefing note with UBS analysts.

Demand for an effective Alzheimer’s treatment is considerable. “Family members have been coming in inquiring about the medi…

Cleveland Clinic, Mount Sinai decide to not use aducanumab for the foreseeable future

The drama surrounding the Alzheimer’s drug Aduhelm (aducanumab) from Biogen (NSDQ:BIIB) continues with the Cleveland Clinic and Mount Sinai refusing to use it until more data are available.

The company’s stock dropped 6.79% to $328.16.

After FDA decided to conditionally approve the drug for Alzheimer’s disease, three members of an FDA advisory committee have resigned, and politicians and advocacy groups such as Public Citizen have asked for the resignations of senior FDA officials. FDA recently agreed to narrow the indication for the drug to focus on patients with milder forms of the disease. FDA itself has called for an independent review of its dealings with Biogen leading up to its approval of the drug. Some internal staff members at FDA have also expressed reservations about the approval, according to The Wall Street Journal.

The Cleveland Clinic said its doctors can still prescribe aducanumab but that patients will need to receive the treatment a…

Lilly’s donanemab could outclass aducanumab, but questions remain

FDA’s approval of Biogen’s (NSDQ:BIIB) and Eisai’s (TYO:4523) Alzheimer’s drug aducanumab has resulted in significant gains in those companies’ shares.

But Lilly’s (NYSE:LLY) donanemab could be “perhaps better and cheaper,” concluded a recent investor note from Truist.

Lilly recently announced that it plans to file for accelerated approval for donanemab in the second half of 2021 under the accelerated approval pathway. As a result, Truist has pushed its launch assumption up two years to 2023 and raised its sales projections for the amyloid-plaque clearing drug.

Assuming the amyloid hypothesis is valid, donanemab holds promise as a potential disease-modifying therapy. In a Phase 2 trial, the investigational drug appeared to promote roughly twice the plaque clearance at 18 months as aducanumab did. Earlier studies also suggested that donanemab cleared plaque aggressively. The potential cognitive benefits of that clearance, however, remain unclear.

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The pandemic and cumulative disease burden are ‘existential’ threats, experts argue

Image courtesy of Pixabay

While the pandemic has highlighted the prowess of the pharmaceutical industry, it should also “serve as a major wake-up call,” said Dr. George Yancopoulos, co-founder, president and CSO of Regeneron (NSDQ:REGN), at a panel at the virtual USA India Chamber of Commerce meeting. COVID-19 has underscored the importance of preparing for infectious pandemics and addressing the burden of all diseases, Yancopoulos added.

Society needs new strategies for addressing the disease burden. “By the year 2050, there will be 10 to 20 million Americans with Alzheimer’s disease with no treatment,” Yancopoulos said. While Biogen’s (NSDQ:BIIB) recently-approved aducanumab could be the first disease-modifying therapy, it remains unclear if the drug is effective.

Added to the disease burden are growing rates of obesity, diabetes, cancer and heart disease — “not to mention the potential of seeing th…

Public Citizen demands FDA resignations after aducanumab approval

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

Get the full story from our sister site, Drug Discovery & Development.

Public Citizen demands FDA resignations after aducanumab approval

The nonprofit watchdog group Public Citizen has sent a letter to HHS Secretary Xavier Becerra “to express its outrage” FDA’s recent approval of Biogen’s (NSDQ:BIIB) Alzheimer’s drug aducanumab (Aduhelm).

Public Citizen concluded that the safety and efficacy profile for the drug was unfavorable and asked that Becerra install an FDA commissioner who would consider withdrawing the Aduhelm approval. Public Citizen also called for the resignation or termination of three FDA officials: Acting FDA Commissioner Dr. Janet Woodcock, Center for Drug Evaluation and Research (CDER) Director Dr. Patrizia Cavazzoni and CDER’s Office of Neuroscience Director Dr. Billy Dunn.

The Alzheimer’s Association had backed the FDA approval, but many experts had concluded there was insufficient evidence to merit even conditional approval of the drug. Three members of an FDA advisory committee who had recommended against aducanumab’s approval recently resigned.

In its letter, Public…

Three members of FDA advisory committee resign after aducanumab approval

FDA’s decision to conditionally approve Biogen’s Aduhelm (aducanumab) continues to cause controversy.

Three members of FDA’s Peripheral and Central Nervous System Drugs Advisory Committee have resigned. The most recent include David S. Knopman, a neurologist at the Mayo Clinic (Rochester, Minn.) and Aaron Kesselheim, a professor at Harvard University (Cambridge, Mass.)

Last November, eight committee members disagreed that there was sufficient clinical trial evidence to suggest that the drug was effective against Alzheimer’s. Another was undecided.

The first to resign was Joel Perlmutter, a neurologist at Washington University (St. Louis).

The three have not gone quietly.

In a letter to acting FDA Commissioner Janet Woodcock, Kesselheim called the aducanumab approval the “worst drug approval decision in recent U.S. history.”

Knopman told The Washington Post that he did not “wish to be part of a sham process.”

Perlmutter was mor…