News

July 23, 2018

Gina Kolata, The New York Times

For Scientists Racing to Cure Alzheimer’s, the Math Is Getting Ugly

A July 23, 2018 New York Times article reported on a new and groundbreaking Eli Lilly Alzheimer’s disease clinical trial. The study tests combination therapies to combat the protein beta amyloid. The article features John Dwyer, President of the Global Alzheimer’s Platform Foundation. Dwyer shares that, while the science has never been more promising, locating trial participants is a seemingly insurmountable obstacle. Experts such as Dr. Daniel Skovronsky, a senior vice president of clinical and product development at Lilly, and researchers across the country talk about their work and the innovative research, including this study, to end the disease.

Read the full article online here.


July 22, 2018

Kelly Song, CNBC

Top Alzheimer’s Researchers Hope That Near-100 Dementia Drugs in Trials Are Moving Closer to a Breakthrough

  • The search for a drug to treat Alzheimer’s disease, the most common form of dementia, has been marked by clinical trial failures.
  • A new report from top researchers says the number of drugs advancing through clinical phase two and phase three trials provides reason to believe that breakthroughs may be in the current pharmaceutical pipeline.
  • The dementia scientists are worried that the history of failures has left the health-care system unprepared to diagnose and treat
    patients if a breakthrough Alzheimer’s drug becomes available.
  • Fifty million people worldwide and six million Americans are living with Alzheimer’s, and the number is expected to rise sharply.

Kelly Song | @ksong18

CNBC.com July 22, 2018


The search for an Alzheimer’s disease cure has been dogged by pharmaceutical failures, but a network of the world’s top dementia scientists released a report on Sunday saying that the number of drugs making it to phase two and phase three of clinical trials encourages them to believe that a blockbuster may be among compounds in the current development pipeline.

“The topline is the numbers,” said UsAgainstAlzheimer’s acting president Drew Holzapfel. “Almost 100 drugs are in the final stages of drug development. … Despite so much national news about failures this year.”

Dr. Jeff Cummings of the Lou Ruvo Center for Brain Health in Las Vegas and a founding member of Researchers Against Alzheimer’s has spent years studying the disease. His annual report on Alzheimer’s drug trials highlights the long history of failures, but he remains confident drug breakthroughs will ultimately be discovered.


Cleveland Clinic Center for Medical Art and Photography

Dr. Jeff Cummings of the Lou Ruvo Center for Brain Health in Las Vegas and a founding member of Researchers Against Alzheimer’s has spent years studying the disease. His annual report on Alzheimer’s drug trials highlights the long history of failures, but he remains confident drug breakthroughs will ultimately be discovered.

The number of drugs in phase two clinical trials has increased 17 percent over the past year, from 58 to 68 drugs, according to the report from nonprofit UsAgainstAlzheimer’s and its affiliate of top scientists, ResearchersAgainstAlzheimer’s. The group forecasts eight of those drugs could make it to the market over the next five years.

Numbers present a mixed picture of drug progress

While the researchers focused on the positives, the report’s overall findings don’t represent a massive change in Alzheimer’s drug landscape. The eight drugs in phase two trials that could come to market is consistent with 2017 report’s forecast for potential market entrants. And the twenty-five Alzheimer’s drugs in phase three testing that are predicted to launch in the next five years represents a 7 percent decline from the 2017 level, according to the report. The overall number of phase three drugs declined by three percent year over year.

Holzapfel said that while the number of drugs in phase three declined, the small level of the decline is encouraging. Given the number of failures in the recent past he reads it is a positive that those running trials are not pulling back more significantly. And the increase in the phase two trials also indicates the potential for a larger phase three pipeline in the near future.

The most disappointing number that has defined the search for an Alzheimer’s cure is 99.6 percent. That is the failure rate for drugs that have been in past development pipelines and has been highlighted in an annual report from Jeff Cummings, director of the Cleveland Clinic Lou Ruvo Center for Brain Health, and a founding member of ResearchersAgainstAlzheimer’s. There were over 100 phase two and phase three clinical trials in 2017, according to Cummings report. It has been 14 years since the last drug was approved to treat Alzheimer’s, and that drug treated symptoms but did not attack the evolution of the disease.


“Often times we talked about trials as failed trials. They’re not failed trials, they’re advancing our knowledge of the science. We are learning from past trials and learning how to attack the disease.”

-Drew Holzapfel, acting president, UsAgainstAlzheimer’s


At least one recent trial has increased hopes for progress in Alzheimer’s drug development. Biogen reported a Alzheimer’s drug breakthrough in early July with positive clinical trial results for BAN2401, the first anti-amyloid drug to achieve statistically significant results at a later stage of Alzheimer’s, 18 months. Still, Biogen’s drug is far from coming to market, with a phase three trial not expected until late 2019 or 2020. And Biogen officials stressed that the results showed the drug could slow the cognitive decline associated with Alzheimer’s, but it did not stop the decline or reverse it.

Alzheimer’s drug research has been criticized for a narrow focus on the protein beta amyloid, including Biogen’s BAN2401, but Holzapfel says progress is being made targeting other Alzheimer’s treatments. There was a 20 percent increase in the number of symptomatic drugs in phase three. Symptomatic treatments can make patients feel better, but they are often temporary and reversible. They do not change the evolution of a disease, such as disease-modifying agents, which is the intention of amyloid drugs. Researchers also note that more trials are focusing on another protein, tau. Among phase two drugs, 11 are targeting the tau protein, a 57 percent increase from a year ago. The number of drugs targeting amyloid is still higher, at 12, but increased less (20 percent).

Holzapfel said that because Alzheimer’s is a multi-factor disease, the most effective treatments will require a cocktail of drugs rather than a single breakthrough.

The focus on past failures may leave health-care providers unprepared for drug breakthrough

The new report from Alzheimer’s researchers includes a concern that the long history of failures with dementia drugs has left health-care systems unprepared for a potential breakthrough. The report said that health-care systems are not keeping pace with the science and are risking a situation where those living with Alzheimer’s disease are unable to access an identified cure.

“The lack of new products in the market has led the health-care systems to be complacent in this area,” Holzapfel said. “Many places don’t feel like there are good treatments, so as a result they delay helping patients and families prepare for the progression.”

Holzpafel previously worked for Pfizer, which announced early in 2018 it was ending its neurological drug research efforts, which critics of the search for an Alzheimer’s drug said supported their view that a cure remains far away.

There is still a lack of proper diagnoses being made for many patients, and a shortage of diagnostic and imaging equipment. There also needs to be an improvement in access to specialists. The waiting time to reach a neurologist can be so long it deters those seeking help, Holzapfel said. As a result, health-care systems also need to increase primary care provider training so they can step in and perform some of the functions of specialists. In the long-term, there also must be a focus on increasing interest in Alzheimer’s study across the medical industry.

Clinical trials also require better infrastructure. The Global Alzheimer’s Platform (GAP) has found a “crippling shortage of clinical trial sites capable of performing pending clinical trials,” which could cause years of delays. There are 200 qualified Alzheimer’s trial sites in North America, but the volume needed would require 500 trial sites, according to Holzapfel, who is also a board member of GAP. The sites required are exceeding current capacity by 230 percent.

Holzapfel is pushing for more funding for health-care systems and clinical trials, despite the history of failures: “Often times we talked about trials as failed trials. They’re not failed trials, they’re advancing our knowledge of the science. We are learning from past trials and learning how to attack the disease.”

He said the “constant drumbeat of failure” also harms clinical trials by making individuals less open to taking part in them, because they associate the search for an Alzheimer’s drug with failure. Increasing the number of individuals in trials has been repeatedly cited by top researchers as one of the keys to finding successful drugs.

It is not only the scientists associated with Sunday’s report who remain optimistic. Earlier this year, the annual Brain Prize worth €1 million was awarded to researchers focused on amyloid targeting. They said the reason the Alzheimer’s drug effort has failed so far is that drugs are delivered at a stage when the disease has already progressed too far. In comments to the press they expressed confidence about finding a successful drug within five years and Alzheimer’s will disappear as a major problem for society within a decade.

 

     Kelly Song  | @ksong18  | kelly.song@nbcuni.com


April 13, 2018

Dane Huffman, Triangle Business Journal

How a Raleigh clinic is helping Alzheimer’s patients

Alzheimer’s clinical trial participants are getting a lift to their appointments at Raleigh Neurology Associates.

The Global Alzheimer’s Platform Foundation, in partnership with Lyft, is providing transportation to participants in an Eli Lilly study testing a therapy to attack plaque in the brain characteristic of Alzheimer’s disease.

Sean Walsh, director of clinical research at Raleigh Neurology Associates, says the new partnership will help the patient experience and increase efficiency and lower costs. Raleigh Neurology is one of 15 participating clinical trial sites.

Atop the list in terms of challenges Raleigh Neurology Associates faces related to Alzheimer’s clinical trials is “getting patients to the site to have research done,” he says. The new partnership between GAP and Lyft will be a “game changer,” he says.

Many Alzheimer’s patients don’t have transportation, Walsh says.


November 13, 2017

Clinical Leader

Can GAP double the number of patients in Alzheimer’s trials?

Curing diseases requires new drugs. Getting those new drugs approved by regulators requires data from successful clinical trials. Those trials depend on patients, and right now getting those patients is a challenge for many sponsor companies. According to research performed on recruitment, 85 percent of trials are delayed due to enrollment issues and more than 30 percent of total trial time is spent simply recruiting patients.

Those issues are present in all therapeutic areas, including Alzheimer’s disease. To mitigate these problems, cut the time of trials, and get needed medicines to patients faster, the Global Alzheimer’s Platform (GAP) Foundation is implementing a new model. The model promises to both accelerate clinical trials and increase patient participation in Alzheimer’s clinical research.

According to GAP, Alzheimer’s disease affects more than 5.4 million Americans and costs taxpayers more than $153 billion per year in Medicare and Medicaid expenses. By the year 2050, it’s estimated that 14 million Americans will be afflicted with the disease. With the aging population we currently have in this country, finding an effective treatment for the disease has never been more important.

Read the full article online here.


November 6, 2017

Kansas City Star

Minority participation in clinical trials can help everyone fight Alzheimer’s

Growing up as an African-American in the South over 75 years ago, my family didn’t have the access to medical care we do today. One event from my childhood changed my life.

My mother went to the doctor’s office. She was quite ill and needed help. The doctor said she had to wait to be seen until after all of the white patients were assisted. It was at that moment I decided to become a doctor.

Since then, times have changed and gotten better, but there’s still a pervasive problem in health care for the African-American community. We are underrepresented in medical research and therefore often last in line when finding effective treatments and therapies for diseases. A particular area that should be of concern to all minority populations is Alzheimer’s disease.

African-Americans are twice as likely to have Alzheimer’s than Caucasians according to the Alzheimer’s Association. The higher rate of prevalence unfortunately translates into a higher death rate. Alzheimer’s deaths increased 55 percent among all Americans between 1999 and 2014, and these deaths increased 99 percent for African-Americans, according to the Centers for Disease Control and Prevention. But this is a point of disparity that we, as a community, can help repair.

Read the full article online here or via PDF here.


May 9, 2017

alzheimersnewstoday.com

Patient advocacy groups welcome 40% increase in Alzheimer’s NIH research funds authorized by Congress

The U.S. Congress last week authorized an additional 40 percent in funds for Alzheimer’s disease (AD) research, boosting the fiscal 2017 total by $400 million to nearly $1.4 billion as part of a $2 billion year-over-year increase for the National Institutes of Health (NIH).

The final package won praise from the nonprofit Global Alzheimer’s Platform Foundation (GAP), a Washington-based entity launched in 2015 by UsAgainstAlzheimer’s and the Global CEO Initiative (CEOi) on Alzheimer’s Disease. GAP works with leading researchers, drug firms, nonprofit groups and governments to slash the time, cost and risk involved in Alzheimer’s clinical trials and speed up approval of innovative medicines and other therapies.

The foundation aims to build a standing global clinical trial platform of willing participants through novel recruitment techniques, coupled with a network of participating high-performance clinical trial sites.

Read the full article online here or via PDF here.


November 26, 2016

Hope to prevent Alzheimer’s? Grab the olive oil and hop on a treadmill

kansas-city-star

By Eric Adler, Kansas City Star

Ann Poehler’s strides quicken on the treadmill. Her feet pound. Her heart races from 150 to 160 beats per minute and more.

A plastic tube jutting from the Prairie Village woman’s mouth feeds carbon dioxide levels to a computer here inside the University of Kansas Alzheimer’s Disease Center. The computer records every respiration while an exercise physiologist coaches her to push harder.

“Can you hang in there like for 15 more seconds?” he urges, making an initial chart of her vitals for an exercise study geared to combat what, for people over 50, is the second-most-feared disease in the United States, just behind cancer. “Good job. Great work. … Hang on.”

At 65, Poehler is cognitively healthy and wants to stay that way. She watched Alzheimer’s rob her grandmother of her memory and life. Now her mother is in a memory care unit.

Like millions of aging Americans, Poehler hopes to escape the cataclysm of the brain-wasting disease that now afflicts some 5.4 million people in the U.S., a number that only promises to grow as baby boomers age, if a cure or preventive is not found.

A national study, published online Monday in the journal JAMA Internal Medicine, offered positive signs on what has long been a bleak landscape. It showed that the rate of dementia in people 65 and older had decreased from 11.6 percent in 2000 to 8.8 percent in 2012 for reasons that, not fully understood, researchers are exploring.

The fact remains that one out of every three people over age 85 in the U.S. — and at least one out of 11 over age 65 — now has clinical Alzheimer’s.

Read the full article online or via PDF here.


September 13, 2016

September 2016 GAP-Net Site Webinar


Aug. 1, 2016

National survey finds that a majority of Americans would consider participating in an Alzheimer’s clinical trial

Shot of a volunteer showing a group of senior women how to use a laptophttp://195.154.178.81/DATA/i_collage/pi/shoots/805700.jpg

A recent online survey conducted by Harris Poll found that nearly 60% of Americans are definitely willing or willing to consider taking part in a clinical trial for Alzheimer’s. This promising statistic is good news for researchers; however, obtaining qualified trial participants has been one of the greatest challenges in getting clinical trials off the ground.

To address this, the Global Alzheimer’s Platform Foundation commissioned a survey to examine Americans’ perceptions about Alzheimer’s disease and to gauge their willingness to participate in clinical trials. The large disconnect between willingness to take part in a clinical trial and actual participation may be attributed to a lack of information provided to the public and a scarcity of easy-to-use tools to begin enrollment in the process.

One solution is for people to join the Brain Health Registry (BHR). BHR is a free, online platform designed to speed the path to cures for Alzheimer’s disease and other brain disorders. BHR gathers data from volunteers who have registered and completed questionnaires and cognitive tests via its website. BHR aims to reduce the cost of patient recruitment for clinical trials by building a large online pool of potential, trial-ready candidates. Join today at www.brainhealthregistry.org.

The Harris Poll survey also asked questions not directly related to clinical trials. Additional findings include:

  • 25% of Americans have/had a family member with the disease.
  • 73% of Americans who do not have Alzheimer’s disease say that if they were to develop the disease, their biggest fear would be not knowing how their family would pay for their care.
  • 28% of Americans believe that health insurance usually covers most of the cost of care for someone with Alzheimer’s disease.
  • 23% of Americans most feared developing Alzheimer’s disease, more than the 18% who said they most feared having a heart attack and 7% who most feared getting shot. 27% most feared another major economic crisis, while 26% said they most feared being targeted in a terrorist attack.

These findings clearly convey that a lot of Americans are aware of and concerned about Alzheimer’s, but that there are also misconceptions. This suggests that even by making the public more aware about the disease, there will be a growing appetite to find a cure.

Tell your friends and family about Alzheimer’s, and encourage them to visit the Brain Health Registry today. Together, we can make Alzheimer’s a distant memory.


June 24, 2016

June 2016 GAP-Net Site Webinar