• Lexington
  • Rockbridge
  • Buena Vista
  • Sports
  • Business
  • Regional
  • In-Depth Reporting
  • About Us
Facebook Twitter Instagram
Rockbridge Report
Rockbridge Report
Facebook Twitter Instagram YouTube LinkedIn
  • Lexington
  • Rockbridge
  • Buena Vista
  • Sports
  • Business
  • Regional
  • In-Depth Reporting
  • About Us
Tuesday, October 3
Rockbridge Report
Home»All Topics»Business»New details emerge on drug that may slow Alzheimer’s disease

New details emerge on drug that may slow Alzheimer’s disease

December 5, 20195 Mins Read

By Marilynn Marchione

SAN DIEGO (AP) — A company that claims to have the first drug to slow mental decline from Alzheimer’s disease made its case to scientists Thursday but left them sharply divided over whether there’s enough evidence of effectiveness for the medicine to warrant federal approval.

Excitement and skepticism have surrounded aducanumab since its developers stopped two studies earlier this year because it didn’t seem to be working, then did a stunning about-face in October and said new results suggest it was effective at a high dose.

During Thursday’s presentation at an Alzheimer’s conference in San Diego, the developers convinced some experts that the drug deserves serious consideration. But others were dubious.

New results were released on the experimental medicine whose maker claims it can slow the decline of Alzheimer’s disease, the most common form of dementia. (AP Photo)

Changes made during the study and unusual analyses of the data made the results hard to interpret. And the newly released results showed the drug made only a very small difference in thinking skills in one study and none in the other.

Alzheimer’s patients and families are desperate for any help, no matter how small, adding pressure on the Food and Drug Administration to approve something.

But with conflicting results, “I don’t see how you can conclude anything other than that another trial needs to be done,” said the Mayo Clinic’s Dr. David Knopman, who was involved in one of the studies.

Laurie Ryan, a dementia scientist at the National Institute on Aging, agreed: “We need more evidence.”

Other doctors who consult for the drug’s developers cheered the results. Dr. Paul Aisen, a dementia specialist at the University of Southern California, said they were “consistent and positive” in showing a benefit at a high dose — “a truly major advance.”

“This is an important moment for the Alzheimer’s community.” – Maria Carrillo, chief science officer at the Alzheimer’s Association

Aducanumab aims to help the body clear harmful plaques, or protein clumps, from the brain. Cambridge, Massachusetts-based Biogen is developing it with Japan’s Eisai Co.

In afternoon trading, the companies’ stocks were up roughly 4%.

The stakes are high for approval or denial.

More than 5 million people in the U.S. and millions more worldwide have Alzheimer’s. Current drugs only temporarily ease symptoms and do not slow the loss of memory and thinking skills.

But approving a drug that isn’t truly effective could expose patients to financial and medical risks and give other drugmakers less incentive to develop better treatments.

The makers of aducanumab undertook two studies, each enrolling about 1,650 people with mild cognitive impairment or mild dementia from Alzheimer’s.

Charles Flagg, who is stricken with Alzheimer’s disease, works on a word puzzle while sitting with his wife Cynthia at their home in Jamestown, R.I. Flagg is participating in a study on the drug Aducanumab. (AP Photo)

Those with a gene that raises their risk of the disease were started on a lower dose because they are more likely to suffer inflammation in the brain from medicines that target plaque.

But as the studies went on and concern about this side effect eased, the rules were changed to let such patients get a higher dose.

A Biogen vice president, Samantha Budd Haeberlein, said more people got the higher dose in one study, and that helps explain why it succeeded and the other one failed.

But the new analyses were done on partial results, and with methods not agreed upon at the outset, which makes any conclusions unreliable, independent experts said.

Also, the drug’s benefits may have looked more impressive than they really were because patients in the placebo group worsened more in the positive study than in the one that failed.

“It’s hard to know exactly what happened here,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation. “I don’t see how the FDA could approve it.”

Questions also arose about the size of any benefit.

The drug did not reverse decline, only slowed the rate of it compared to the placebo group by 22% in one study. Yet that meant a difference of only 0.39 on an 18-point score of thinking skills.

“It’s a very small amount,” Fillit said.

Charles Flagg, who is stricken with Alzheimer’s disease, sits for an infusion while participating in a study on the drug Aducanumab at Butler Hospital in Providence, R.I. (AP Photo)

Still, Maria Carrillo, chief science officer at the Alzheimer’s Association, said it was “the largest reduction that we’ve seen to date,” adding: “It may mean that they remember their loved ones a little longer.”

The drug “is worthy of significant, rigorous exploration” and review by the FDA, she said. “This is an important moment for the Alzheimer’s community.”

Some doctors and patients who helped test the drug are convinced it helped.

One was Charles Flagg, 78, a retired minister from Jamestown, Rhode Island, who received aducanumab until the studies were halted in March. Since he was taken off the medicine, “his cognition, his alertness, his interactions have definitely diminished,” said his wife, Cynthia Flagg.

Biogen stressed the need for an effective treatment and suggested that delaying access to a drug that may work could deprive many people of help while further study is done.

Dr. John Ioannidis, a Stanford University expert on research methods, said patients’ need should not drive the FDA’s decision.

“If we go down that path, we’re likely to introduce a lot of ineffective treatments for diseases that are really common,” he said. “It would be a complete mess.”

Related

Sept. 8, 2023 Newscast

rockbridgereport

The commonwealth’s attorney for Rockbridge Count The commonwealth’s attorney for Rockbridge County and Lexington said he wants victims of sexual assault at Washington and Lee University to seek help from police and prosecutors who can investigate and file criminal charges. 

In the past month, two former W&L students have faced sexual assault charges.

Read Ned Newton’s full story on our website, rockbridgereport.wlu.edu.
Lexington’s City Council has given the go-ahead Lexington’s City Council has given the go-ahead for a developer to begin drafting plans to build apartments off Spotswood Drive. 

The new permit approval comes after months of controversy about the design. 

Read Andrew Arnold’s full story on our website, rockbridgereport.wlu.edu.
A new, 24-hour EMS crew will help in providing bac A new, 24-hour EMS crew will help in providing backup services to Glasgow and other nearby cities and towns.

For more details on the new EMS crew, visit: https://youtu.be/k03HNBKB978.
Buddy, the horse, and Police Chief Angela Greene l Buddy, the horse, and Police Chief Angela Greene led the Lexington Christmas Parade. Buddy is one of the future Mounted Police Unit horses working with the Lexington police. 

Watch Buddy and the latest broadcast of the Rockbridge Report: https://www.youtube.com/watch?v=SDZ4A6xuk-4
A developer sought final city approval this week t A developer sought final city approval this week to build 62 apartment units on Lexington’s Spotswood Drive.

Echelon Resources went before the city’s planning commission Thursday to request a permit allowing the developer company to construct multi-family housing at the Spotswood site. The planning commission will offer a recommendation for approval or denial to the Lexington City Council. The city council will likely have a final vote on the permit in early January.

The proposal received some pushback from Lexington residents who fear the development will significantly increase traffic, impede the local hospital, or strain the city’s water and sewer systems. 

For more details on the Spotswood proposal visit: https://rockbridgereport.academic.wlu.edu/2022/12/08/spotswood-drive-apartment-complex-moves-forward/
Lexington’s city manager is searching for a full Lexington’s city manager is searching for a full-time city attorney. The previous city attorney, Jared Jenkins, no longer serves in the position following his split from Mann Legal Group.

Learn more by visiting the Rockbridge Report website: https://rockbridgereport.academic.wlu.edu/2022/12/08/lexington-replaces-city-attorney/
Two students at Virginia Military Institute and Wa Two students at Virginia Military Institute and Washington and Lee University posted bomb threats on anonymous social media platforms last week.

After investigations, both posts proved to be false alarms. Disciplinary measures for the students are unclear. 

Read the full story here: https://rockbridgereport.academic.wlu.edu/2022/12/08/two-university-bomb-threats-posted-on-anonymous-social-media-proved-false/
Local nonprofits, like the Rockbridge Area Relief Local nonprofits, like the Rockbridge Area Relief Association (RARA) and Washington and Lee’s Campus Kitchen, will provide extra support for families facing food insecurity during the holidays.

Read more about this on the Rockbridge Report website: https://rockbridgereport.academic.wlu.edu/2022/12/08/community-groups-to-offer-food-to-students-and-their-families-during-holiday-break/
“Normal people can’t afford that." Lexington “Normal people can’t afford that."

Lexington is Stacey Dickerson-Suggs’ hometown, but the single mother can’t afford to live here. Virginia house prices are going up about 10% each year. In Lexington, the median price of a home has increased 27% in the past year.

Read more about this on the Rockbridge Report website: https://rockbridgereport.academic.wlu.edu/2022/12/08/lexington-renters-buyers-cant-find-affordable-housing/
Load More... Follow on Instagram
Twitter
My Tweets
Reporters

Luke Fountain

Jenny Hellwig

Jak Krouse

Emma Malinak

Fraley Williams

Producers

Christian Basnight

Jack Hunter

Teddy Jacobsen

Ned Newton

Billy Queally

 

Supervisors

Kevin Finch

Alecia Swasy

Michael Todd

Rockbridge Report
© 2023 ThemeSphere. Designed by ThemeSphere.

Type above and press Enter to search. Press Esc to cancel.

Go to mobile version
 

Loading Comments...