Miami Herald (Sunday)

WHAT TO KNOW ABOUT THE NEW, FDA-APPROVED ALZHEIMER’S DRUG

- BY HANNAH CRITCHFIEL­D Tampa Bay Times

A new drug that appears to slow early Alzheimer’s disease is coming to the market.

The Food and Drug Administra­tion earlier this month approved lecanemab, which will be marketed as Leqembi, for public use.

The decision comes after data published in

The New England Journal of Medicine in November showed that people who took the drug experience­d “moderately less decline on measures of cognition and function.”

However, some patients also experience­d negative side effects like brain swelling and bleeding – meaning people will need to receive regular brain scans after starting treatment.

It’s also unclear if Medicare will cover Leqembi, which is expected to cost tens of thousands of dollars each year.

Leqembi is the second drug of its kind to receive market approval and is expected to be more commercial­ly successful than its predecesso­r, Aduhelm. The controvers­ial treatment, also known as aducanamab, received federal approval in 2021, despite limited results that the drug helped patients.

Here’s what to know:

HOW DOES IT WORK?

Leqembi decreases the amount of amyloid plaque in the brain. The protein deposits have long been hypothesiz­ed to be linked to the progressio­n of Alzheimer’s.

Reduce the plaque, the theory posits, and you’ll slow the effects of the memory disease.

Existing data on Leqembi provides the strongest support for that theory to date. However, the drug, if effective, is not a cure for Alzheimer’s.

“But it can help people retain memories,” said Stefanie Wardlow, a senior program manager at the Florida Alzheimer’s Associatio­n. “So they’re able to enjoy more time.”

The 18-month study published in November, which was funded by its manufactur­ers and involved people aged 50 to 90 with early Alzheimer’s, neverthele­ss concluded by noting that “longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease.”

WHO CAN TAKE LEQEMBI?

The intravenou­s medication is intended for people with mild cognitive impairment or dementia due to Alzheimer’s disease.

People with more advanced Alzheimer’s will likely not be eligible for the treatment.

Given the negative side effects experience­d by some patients involved in the study, people should consult their doctors when considerin­g whether to seek out Leqembi.

WHEN WILL IT BE AVAILABLE?

Leqembi is expected to become available by the end of January, Wardlow said.

People who are interested and eligible should speak to their doctors about how they can access the drug.

The federal government greenlit Leqembi on an accelerate­d approval pathway, a conditiona­l status granted to drugs aimed at serious conditions where there is an “unmet medical need.” The drug must also have enough evidence to suggest there is a “likely” clinical benefit for patients.

The provisiona­l approval means Alzheimer’s patients can start taking Leqembi now while the federal agency continues to review additional data about its effectiven­ess. The Food and Drug Administra­tion will likely decide whether to grant the drug full approval in the fall, Wardlow said.

HOW MUCH WILL IT COST?

Esai, which manufactur­ed the drug in partnershi­p with biotech giant Biogen, has said the treatment will cost $26,500 annually.

It’s unclear if the drug will be covered by the Centers for Medicare & Medicaid Services.

In an April 2022 decision, the agency indicated that it generally will not pay for Alzheimer’s treatments aimed at attacking amyloid plaque until they receive full approval by the Food and Drug Administra­tion, except in clinical trial settings.

Critics, including organizati­ons like the Florida Alzheimer’s Associatio­n, have asked Medicare to reconsider its policy, stating that out-of-pocket costs will make Leqembi inaccessib­le for many people with early-onset Alzheimer’s.

The Satechi Thunderbol­t 4 plug-and-play dock brings everything together in a Mac workstatio­n with ports for everything you could need to be connected.

Satechi describes it as a powerhouse for users of the new Apple M1 processor.

One connection from the compact 7.4-by-3.3-by-1.1inch dock to a computer gives 11 ports in return. They include four traditiona­l USB-A ports (three 3.2 data ports, one SUB 2.0 charging), three Thunderbol­t 4 ports, UHS-II memory card readers, one Gigabit Ethernet and a 3.5mm audio jack port. All are built into an Apple matching dock with an aluminum finish with padded grips, so it stays in place.

All the ports, external hard drives, displays, keyboards, mice, headphones, etc., can be connected and work together. The dock supports up to two external monitors simultaneo­usly.

An AC adapter is included and is excellent to use for an extra power boost.

The Satechi website lists compatible Apple and Microsoft devices. A USB-C connection cable is included. Cost: $299.99 https://satechi.net

There are plenty of streaming apps like Spotify and Apple Music that make listening to music easier than ever. But for true audiophile­s, there’s nothing that compares to the rich sound of records on a turntable. Which is why CNET has tested and rounded up some of the very best record players on the market.

There’s a difference in sound quality that music streaming can’t quite compete with. There’s nothing quite like picking up one of your favorite vinyl records, pulling it out of its sleeve and placing it on a turntable. As the needle drops on to the shiny vinyl, you’re transporte­d by the performanc­es of your most beloved artists.

Music enthusiast­s on the lookout for a new system, with vinyl at its core, now have a lot of options. Not only can you find affordable speakers, but there are also plenty of high-quality turntables, including models with Bluetooth connectivi­ty. Superior analog sound often requires spending more money, but it’s not necessary. If you’re a vinyl enthusiast, you could start with something like the $149 Audio-Technica ATLP60X workhorse, or you could decide to go all out with the new U-Turn Orbit Theory. Any of our best record player picks should provide great sound to have you spinning vinyl for years to

Florida millennial Matt Gaetz, who has 2 million Twitter followers and hosts a podcast, joined with a band of fellow Republican­s recently to make life difficult for nowSpeaker Kevin McCarthy from the earliest moments of the new Congress.

And as for previous years, Burgat points to New York Democrat Alexandria Ocasio-Cortez’s ability to extract concession­s from party leaders.

“You can kind of skip to the front of the line with a national brand,” he said. “She was a player in negotiatin­g whether Speaker Pelosi got the gavel back, and that’s why the Select Committee on the Climate Crisis effectivel­y happened.” come.

Best record player for the money: Fluance RT82

CNET take: The Fluance RT82 offers

Seniority often rules on the Hill, along with old adages: pay your dues, wait your turn. But there’s a reason for some of that, said Ohio Democrat Marcy Kaptur, who became the longest-serving woman in congressio­nal history at the start of this term.

“We’ve moved into an era of a lot of instant food, instant oatmeal and instant communicat­ion, but building a nation isn’t everything you could want except an onboard preamp, so if you have a receiver or amplifier with a dedicated phono input, this is the model to get. instant. You have to dig in. It’s like growing a tree,” she said.

While some see generation­al divides as crucial to understand­ing American politics, not everyone is buying it. Sen. Charles E. Grassley of Iowa, who is set to turn 90 in September, said lawmakers can connect with all ages if they try.

The same goes for getting along with colleagues

We were mightily impressed by the wellthough­t-out inclusions with the Fluance. Autostart on/off, adjustable feet and even a little bubble-level were included with the user in mind. This high-quality turntable had one of the most entertaini­ng sounds of the $300 turntables, with plenty of insight into recordings as well as a healthy bass kick.

Best ultra-budget turntable: Audio-Technica AT-LP60X

CNET take: If you’re just starting out in vinyl or looking for a cheap turntable to give as a gift, the inexpensiv­e AudioTechn­ica AT-LP60X belt-driven turntable offers the warm sound you’ve heard about. Plus, it offers fully automatic operation. It also includes a limited upgrade path with a choice of line or phono output, allowing users to add their own preamp. This automatic turntable option is a great value.

Best turntable under $1,000: U-Turn Orbit Theory

CNET take: The Orbit Theory may look similar to the original Orbit Plus, but this is a vastly superior turntable. Seemingly every component has been upgraded – from a hardwood plinth to a solid magnesium tonearm – and of course, U-Turn charges handsomely for these improvemen­ts at $999.

The record player is assembled in the U.S., while the new arm tube is also manufactur­ed here, and the Orbit incorporat­es almost every must-have feature (save for automatic operation). The model has adjustable feet, speed control, a nifty tonearm lift and almost everything is preinstall­ed at the factory. While the package also comes with a felt mat, I found it sounded better without.

‘‘ IT’S JUST EXCITING TO BE PART OF A NEW CADRE AND A NEW CHANGING OF THE GUARD. Florida Democrat Maxwell Alejandro Frost, 25

on Capitol Hill, as he recalls doing in his early Senate days. “I was 46 years old and everybody else was 75 years old. It’ll be the same this time,” he said.

Hawaii’s Brian Schatz was born in 1972, and he calls himself “young for the Senate.” He used to think bringing younger generation­s to Congress would be a panacea for all of America’s problems.

He doesn’t think that anymore. “I’ve seen almost no correlatio­n between the age of the member and the quality of their service,” he says. “It depends whether you’re talking about Madison Cawthorn, or somebody a little more serious.”

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 ?? AP ?? This image provided by Eisai shows vials and packaging for its medication Leqembi. On Jan. 6, 2023, U.S. health officials approved Leqembi, a new Alzheimer’s drug that modestly slows the brain-robbing disease.
AP This image provided by Eisai shows vials and packaging for its medication Leqembi. On Jan. 6, 2023, U.S. health officials approved Leqembi, a new Alzheimer’s drug that modestly slows the brain-robbing disease.
 ?? Miami Herald file ?? Stress fractures or a herniated disc in the lower back are common injuries in basketball as players hyperexten­d their lower back repeatedly.
Miami Herald file Stress fractures or a herniated disc in the lower back are common injuries in basketball as players hyperexten­d their lower back repeatedly.
 ?? PATRICK SEMANSKY AP ?? The U.S. Capitol Dome is seen from the House carriage entrance on Capitol Hill in Washington.
PATRICK SEMANSKY AP The U.S. Capitol Dome is seen from the House carriage entrance on Capitol Hill in Washington.
 ?? TY PENDLEBURY CNET/TNS ?? The Audio-Technica AT-LP60X offers fully automatic operation.
TY PENDLEBURY CNET/TNS The Audio-Technica AT-LP60X offers fully automatic operation.
 ?? SATECHI TNS ?? One connection from the Satechi Thunderbol­t 4 dock to a computer gives 11 ports in return.
SATECHI TNS One connection from the Satechi Thunderbol­t 4 dock to a computer gives 11 ports in return.

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