El Faro Health and Therapeutics Now Enrolling Participants from Rio Grande Valley Community in Global Alzheimer’s Platform Foundation® Bio-Hermes Alzheimer’s Study

Despite highest incidence of dementia, this is the first-ever Alzheimer’s clinical study in Starr County

Rio Grande City, TX (February 2, 2022) –El Faro Health & Therapeutics will begin screening volunteers for its first-ever clinical trial in Rio Grande City, TX. The Bio-Hermes Study, sponsored by the Global Alzheimer’s Platform Foundation® (GAP), seeks volunteers with or without memory concerns to help assess blood and digital tests that could help predict the presence of amyloid plaques in the brain.

Dr. Falcon, a family physician, regional heath authority and Baylor College of Medicine Trustee, and his son Dr. James Falcon, founded El Faro to provide access to research opportunities and mitigate the impacts of Alzheimer’s for families in their native Rio Grande Valley. El Faro recently joined GAP-Net, a global consortium of over 100 clinical trial sites, working to find a cure for Alzheimer’s and Parkinson’s disease. GAP-Net membership gives the site unique access to resources that aid in trial management, recruitment, and success.

“El Faro offers people in Starr County desperately needed access to Alzheimer’s resources, education, and research opportunities. That begins with GAP’s Bio-Hermes study,” said Dr. Antonio Falcon. “The Alzheimer’s public health crisis happening in Starr County and in communities like ours across the nation highlights why we need to direct our attention to providing clinical trials in underrepresented communities.”

Bio-Hermes is the first-ever platform study to compare results of blood and digital biomarker tests, including digital cognitive and voice assessments, with the results of brain amyloid PET scans and traditional cognitive tests. GAP’s Bio-Hermes study database will allow scientists to assess the ability of each biomarker, or combination of biomarkers, to indicate the accumulation of amyloid in the brain – the hallmark of Alzheimer’s. Use of biomarkers could lead to earlier and more frequent detection of Alzheimer’s disease, affording those affected an opportunity to seek early intervention, including participation in clinical trials for Alzheimer’s prevention or treatment.

Understanding Alzheimer’s disease is particularly important in a community like Starr County – which is 97% Hispanic – with the highest prevalence of Alzheimer’s in the country at nearly 23% and has severely lacked local, accessible research opportunities before the opening of El Faro. Nationally, Hispanics are 1.5 times more likely to have Alzheimer’s or other dementias but are also less likely to be diagnosed due to misdiagnosis, lack of accessibility, language barriers, and certain health factors. As a result, Hispanics are often diagnosed later in the disease progression, with fewer options for treatment and research.

“El Faro will be a case study in how to bring complex clinical trials and resources to rural communities, especially traditionally underrepresented communities,” said John Dwyer, President of GAP. “In working with El Faro to enroll in Bio-Hermes, we are demonstrating to the world that it is possible to make progress toward true equity in Alzheimer’s research through partnering with local leaders and their communities.”

The Bio-Hermes study is unique in that the sponsor has committed to holding the trial open until at least 20% of participants are Hispanic and Black. The study, on schedule to be completed in April, is on track to meet this goal. This is unheard of in Alzheimer’s research, and medical research more broadly. In fact, the Bio-Hermes goal is four times the national average for enrollment from traditionally underrepresented communities.

The Bio-Hermes study offers volunteers a study-related PET brain scan at no cost. PET scans are particularly valuable for the Alzheimer’s community as they are the gold standard for a diagnosis and allow individuals critical information to help take charge of their own brain health, however they are prohibitively expensive.

Volunteers for the Bio-Hermes study must be between 60-85 years old and have someone who can participate with them as a study partner. The study includes two visits with site staff and one visit to a local imaging center over the course of three months, with the potential for a follow-up phone call (if needed).

El Faro will address the disproportionate levels of Alzheimer’s in the Rio Grande. GAP’s collaboration with Dr. Falcon and local partners is one further example of GAP’s commitment to diversity and inclusion in clinical research.

About the Global Alzheimer’s Platform Foundation® (GAP)

The Global Alzheimer’s Platform Foundation® (GAP) is a person-centric nonprofit dedicated to?accelerating?the delivery of innovative therapies for neurological disorders by reducing the?duration?and cost of clinical trials. Research centers?across the US, Canada, and Europe?are part of the growing GAP Network (GAP-Net). GAP supports?GAP-Net research centers by assisting with?study start up and recruitment activities,?promoting?diversity in research studies, and?offering?international clinical trial infrastructure, resources, and programs that champion brain health and the citizen scientists who make research possible.

About El Faro Health and Therapeutics

El Faro Health and Therapeutics is a clinical research site primarily engaged in Alzheimer’s disease research and treatment. It is the first private clinical research site in Starr County, TX, the county with the highest Alzheimer’s prevalence in the nation. El Faro is affiliated with the Global Alzheimer’s Platform Foundation Network (GAP-NET) with access to international clinical trial infrastructure and innovations in the research field.

Dr. Antonio Falcon is an esteemed health care provider in his native Rio Grande City and across the U.S. – with more than 44 years of experience as a family physician treating a myriad of diseases, including dementia and Alzheimer’s. He was a member of the United States-Mexico Border Health Commission, a Commissioner for the Texas Parks and Wildlife Commission, and a Board Member for the Texas Medical Foundation Institute for Health Quality. Dr. Falcon was named Family Physician of the Year by the Texas Academy of Family Physicians in 2015. He also was recently appointed as a trustee to the Baylor College of Medicine, his alma mater. Dr. Antonio Falcon will lead El Faro with his son Dr. James Falcon, a physician in Texas who served as an emergency medical physician in the United States Army – both domestically and while deployed to combat zones.

Medicare Coverage-In-Clinical-Trials Policy For Alzheimer’s Drugs Could Stifle Access For Years

GAP President John Dwyer spoke to Pink Sheet about the CMS NCD proposal.

The Centers for Medicare and Medicaid Service’s proposal to allow Medicare to pay for amyloid-directed monoclonal antibody drugs for Alzheimer’s only when they are used in randomized controlled clinical trials could significantly curtail access to the drugs for at least four years, according to John Dwyer, president of the Global Alzheimer’s Platform Foundation and co-founder of UsAgainstAlzheimer’s.

Dwyer discussed the practical challenges posed by the coverage with evidence development requirement in the Medicare draft national coverage determination in an interview with the Pink Sheet. The Global Alzheimer’s Platform Foundation works on speeding the delivery of innovative Alzheimer’s disease therapies by enhancing the efficiency of clinical trials. Funding for the work comes from philanthropies and pharmaceutical firms.

The NCD, if finalized in its current form, would restrict access to Biogen, Inc. and Eisai Co., Ltd.’s currently marketed Aduhelm (aducanumab) and drugs in development from Eli Lilly and Company (donanemab), Eisai (lecanemab) and Roche Holding AG (gantenerumab). It was released on 11 January.

CMS has emphasized that it welcomes public comments on the draft, which suggests the agency might change its
mind about the requirement.

“My estimate is this is going to add a minimum of four, maybe up to six or seven years’ delay for any volume of patients to get on this therapy or any of its sister therapies if they go through with this,” Dwyer said.

“In my professional experience you will not get the first CMS study as described in this proposal even started until the fourth quarter of 2023,” he pointed out. “Basically, it takes two years to start one and then, who knows how many years we’ll need to enroll and track what constitutes clinical benefit to satisfy Medicare,” which “is not clearly stated [in the NCD] and that is not a trivial question.” He also noted CMS emphasizes it wants data showing the safety and efficacy of the drugs in the Medicare population, including African Americans and Latinos who are underrepresented in clinical trials. But that is notoriously difficult to achieve and will slow enrollment and completion of studies even further, Dwyer maintained.

CMS’s proposed requirement that trials be conducted in hospital outpatient centers presents further challenges
because “major hospital systems have not traditionally been fast or successful at recruiting underrepresented
populations, even though some are nestled in African American or Latino communities,” he said. CMS has said, “’We want to ensure equity and access here,’ but the math doesn’t work, and the locations don’t work.” Furthermore, whether enrollees would be responsible for a copay on treatment “is yet to be determined.”

It is unclear whether clinical trials being planned by Biogen and Lilly would meet CMS’s standards for qualifying studies under the NCD, Dwyer noted. Biogen is gearing up for a confirmatory randomized controlled trial that it is required to conduct under Aduhelm’s accelerated approval.

The company plans to begin patient screening for the study in May, with a primary completion date of approximately four years after the study begins – almost twice as fast as the original timeline specified by the FDA.

Lilly is planning a Phase III head-to-head study of donanemab versus Aduhelm for plaque clearance, which could have data in the second half of 2022. The company is also seeking an accelerated approval for donanemab from the US Food and Drug Administration.

Instead of moving ahead with the coverage with evidence development requirement, “I strongly believe [CMS] needs to clear off the RCT structure” at least until “they get another study out of the field, like the Lilly head-to- head maybe,” Dwyer said. “But what I really think is give the drug coverage but be very prescriptive on the conditions for prescribing,” including “rigorous MRIs” to detect or address amyloid-related imaging abnormalities (ARIA) if it occurs, he emphasized. Unless it is modified, “I’m reading [the draft NCD] as saying any drug coming out of FDA with accelerated approval irrespective of their data … goes through this process,” Dwyer said. “For industry, why would you go through the trouble of conducting an RCT” on a drug candidate “and spend hundreds of millions, if not $1bn on it, for the luxury and privilege of doing it all over again for CMS?”

Originally posted by Pink Sheet on January 17, 2022.

STATEMENT: Global Alzheimer’s Platform Foundation® Applauds Biogen for 18 Percent Diversity Recruitment Goal for Participants in Aduhelm Confirmatory Trial

Washington, D.C. (January 27, 2021) – John Dwyer, President of the Global Alzheimer’s Platform Foundation® (GAP), a person-centric non-profit organization committed to accelerating the discovery of therapies for the treatment of Alzheimer’s, applauded the announcement today by Biogen Inc. that it would ensure that at least 18 percent of participants in its FDA mandated study will be from diverse populations.

“Clinical trials of Alzheimer’s therapeutics commonly only include 2-3 percent of African American and Latino individuals in the studies. Today’s announcement by Biogen—a leading global biotechnology company—to enroll 18 percent of the trial participants from African American and Latino communities for their ENVISON confirmatory study for Aduhelm, the first and only Alzheimer’s disease modifying treatment to address the disease, is a significant step towards giving these communities access to a drug that treats a disease that ravages their families and friends. It should be the baseline goal for all drug manufacturers across all diseases. We commend the efforts by Biogen to improve equity in medical research and treatment for America’s most vulnerable patients.

Older African American and Latino Americans are twice and one-and-a-half times more likely, respectively, to have Alzheimer’s or other dementias—so Biogen’s announcement today takes direct aim at addressing inequities in health research for these disproportionately affected communities.

This pledge from Biogen comes on the heels of GAP’s own efforts to bring attention to the critical need to improve clinical trial participation for underrepresented groups. GAP’s very own Bio-Hermes trial made an immutable commitment to ensure that 20 percent of the African American and Latino community is represented in clinical trials. Bio-Hermes is on pace to reach or exceed this goal later this year.

For the first time in nearly 20 years, Alzheimer’s patients could access an FDA approved therapy — a therapy for a condition that has no other treatment. At the urging of GAP and other patient groups, Biogen has taken steps to address the access issue by substantially reducing the drug’s price and now has committed to enrolling populations that are more representative of the population living with Alzheimer’s, working to ensure that future Alzheimer’s therapies are inclusive for all affected by this scourge.

It is now time for CMS to reimburse the cost of this drug, as it has for all similarly FDA-approved treatments for various other diseases, so that millions of Alzheimer’s patients might benefit. Do not make us wait any longer.”

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About the Global Alzheimer’s Platform Foundation® (GAP)

‘Not a tolerable situation’: Patient Groups Take Aim at CMS Over Alzheimer’s Coverage Decision

GAP President John Dwyer was quoted in Politico talking about the difficulty of having a diverse population pool in Alzheimer’s clinical trial, and how unlike that is to achieve if the CMS proposal is approved.

Drugmakers and patient advocacy groups are waging a campaign to cast Medicare officials as villains after the program limited coverage of a pricey new Alzheimer’s drug and demanded tougher criteria than the FDA to prove it works.

Their goal is to strong arm the Centers for Medicare and Medicaid Services into covering Aduhelm, the $28,200-per-year drug, for far more people.

The effort comes in response to Medicare’s decision to only cover Biogen’s new treatment for patients enrolled in ongoing clinical trials, effectively cutting off access to the first new Alzheimer’s drug in nearly two decades, which the Food and Drug Administration approved in June despite conflicting trial results. The preliminary decision applies not only to Aduhelm, but the whole class of similar drugs, many of which are in development.https://41f0601d6a5d4b14cc3c2484c7a4f8c8.safeframe.googlesyndication.com/safeframe/1-0-38/html/container.html

“If drugs go through the FDA, get approved and then have to go through another clinical trial process to get coverage, then no one’s going to invest in this space,” said George Vradenburg, the chair and co-founder of patient group UsAgainstAlzheimer’s. “This is just not a tolerable situation. FDA was charged with this decision, they made the decision, CMS should honor it.”

Lee Fleisher, the agency’s chief medical officer and director of the Center for Clinical Standards and Quality, said in a statement after the decision that their goal was to protect Medicare recipients “from an intervention without known benefits.”

The FDA and the Department of Health and Human Services did not respond to requests for comment.

This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. — This image provided by Biogen shows a vial and packaging for the drug Aduhelm. | Biogen via AP

While the various supporters of broader access have not yet coalesced around a single strategy, broad outlines of a plan are already becoming clear.

Advocates are enlisting patients, investors and health professionals to flood CMS with comments opposing its proposal. As of Friday, nearly 80 comments had been submitted, less than a week into the 30-day public comment period following the CMS decision. Many of these comments express concern and frustration with how few patients could receive Aduhelm under the agency’s proposed plans.

Biogen declined to comment on its strategy, but the company told investors that it hoped CMS would revise its decision and cover the drug for patients who mirrored the populations that were already included in clinical trials. Michel Vounatsos, Biogen’s chief executive, said the company had a plan to manage the fallout but declined to elaborate during a call with analysts on Thursday.

Separately, patient groups and pharmaceutical lobbyists plan to pressure Congress, making the case that CMS is stifling innovation and also creating a paradigm that will disproportionately harm patients with low incomes and patients of color.

“On the Hill, a lot of people care about Alzheimer’s,” Vradenburg said. “There will be letters. There’ll be meetings. There’ll be everything we can muster to turn that decision around.”

Harry Johns, the chief executive of the Alzheimer’s Association, said his group plans to lobby the White House, warning that millions of patients will be left without a drug they thought they could soon receive.

“It’s hard for us to believe that this president and this administration wants to be responsible for setting the precedent of not covering a treatment approved by the FDA and, more specifically, causing this kind of difference in coverage that is available for other diseases that would not be for people with Alzheimer’s,” he said.

It is rare but not unheard of for CMS to change trial participation requirements between a draft and final coverage decision. In 2019, CMS proposed requiring hospitals administering CAR-T therapies to track patients in observational studies. Hospitals complained it was too burdensome and CMS relented.

The agency plans to make a final determination on Aduhelm in April.

CMS’ requirements for Aduhelm are even more burdensome, said John Dwyer, president of the Global Alzheimer’s Platform Foundation. The proposed trials must be randomized and conducted at a hospital-based outpatient setting, and the diversity of participants should be representative of the patient population diagnosed, a standard that is nearly impossible to achieve, he added — and certainly not in a timely manner.

“There’s never been an Alzheimer’s study that has closely approximated the percentage of African Americans that have Alzheimer’s or Latinos that have Alzheimer’s in terms of the enrollment,” he said.

In a statement to POLITICO, CMS Administrator Chiquita Brooks-LaSure said that the diverse population requirements were there to rectify past underrepresentation in Alzheimer’s research.

“We are creating every incentive for manufacturers and trial administrators to ensure that the clinical trials recruit diverse participants,” she said. “The equity implications of this decision were a central part of the hard, thoughtful work that went into developing this proposed [coverage].”

Some public health experts and members of Congress have already expressed support for the agency.

“This was the best decision,” said R. Scott Turner, a neurologist and director of the Memory Disorders Program at Georgetown University Medical Center. Turner has been involved in conducting clinical trials for Aduhelm and other anti-amyloid drugs for over eight years but doesn’t believe they should be available beyond a research setting.

“I don’t think it should have been approved by the FDA, frankly,” he said.

FDA granted Biogen’s drug accelerated approval despite mixed results in clinical trials, saying that because Aduhelm reduced the amount of amyloid — a deformed protein thought to be the root of cognitive decline in Alzheimer’s — in participants’ brains, it was “reasonably likely” that it would ultimately slow or stop patients’ cognitive decline.

Several scientists disagreed with the assessment, including those on FDA’s external advisory panel for neurological drugs; three of them resigned in protest. Only one, David Knopman, responded to POLITICO for comment, saying that he agreed with CMS’ proposed decision.https://41f0601d6a5d4b14cc3c2484c7a4f8c8.safeframe.googlesyndication.com/safeframe/1-0-38/html/container.html

CMS, in explaining why it limited coverage, said that because there has never been a trial demonstrating that reducing amyloid meaningfully improves patients’ health outcomes with Alzheimer’s, there was “insufficient evidence” that Aduhelm would be reasonable and necessary for Medicare beneficiaries.

Pharmaceutical advocates told POLITICO that by effectively overruling the FDA, CMS could chill investment in drug development.

“Alzheimer’s is an area that has just been littered with the carcasses of failed efforts,” said one pharmaceutical lobbyist, who asked for anonymity to speak freely about the industry. “Back in 2018, Pfizer just abandoned the field entirely … [Eli] Lilly has sunk hundreds of millions of dollars here. So I would definitely never underestimate that your adding these obstacles has real impact.”

The CMS decision goes beyond Aduhelm. All similar drugs would be subject to the same requirements, which critics say would make it difficult even for drugs that perform better during clinical trials.

John Murphy, the chief policy officer at the Biotechnology Innovation Organization, an industry group, said that CMS “has gone well beyond its statutory mandate.”

“This is the epitome of the agency throwing the baby out with the bathwater,” Murphy said. “CMS is purposely turning one product into a pariah to stand up on a pedestal, and doing it at the expense of all future development of other products yet to come and patients who desperately need innovation in this disease state.”

Eli Lilly and Genentech both have similar anti-amyloid Alzheimer’s drugs in the pipeline, in addition to a second offering from Biogen. Both companies expressed concern that CMS’ proposal would deny patients access to forthcoming drugs.

“CMS is writing off an entire class of medicines before multiple products have even been reviewed by FDA, positioning itself and not FDA as the key arbiter of clinical evidence,” Nicole Longo, a spokesperson for the Pharmaceutical Research and Manufacturers of America, said in a statement after the agency’s proposal was released. The group declined to comment about its advocacy efforts.

The fact that CMS is considering requiring a randomized trial makes industry and patient groups wary of the delay in getting the drug to patients, and lobbyists note that novel treatments are often flawed as a result of being first.

“Innovation is incremental oftentimes and we have to show a willingness to be flexible,” Murphy said. “Right now, [CMS is] just backdoor disapproving the drug.”

Originally posted by Politico.com on January 17, 2022.

Global Alzheimer’s Platform Foundation® (GAP) Condemns CMS Preliminary Coverage Decision on First Disease Modifying Drug for Alzheimer’s as Repudiation of President’s Promise to Advance Treatments for Alzheimer’s for all Americans

GAP calls for a traditional National Coverage Determination for ADUHELM consistent with past CMS decisions which will ensure access and equity for all patients stricken with Alzheimer’s.

Washington, D.C. (January 11, 2022) – John Dwyer, President of the Global Alzheimer’s Platform Foundation® (GAP), a person-centric non-profit organization committed to accelerating the discovery of therapies for the treatment of Alzheimer’s, issued the following statement on the announcement today by the Centers for Medicare and Medicaid Services (CMS) of a preliminary proposal to cover U.S. Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED) – which means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials.

“CMS’s preliminary decision to delay and restrict coverage for the first disease modifying drug for Alzheimer’s is unprecedented, reckless, and stands in direct opposition to the President’s personal commitment to better address the Alzheimer’s public health crisis in the U.S. and improve access to life prolonging Alzheimer’s therapies for all Americans.

The FDA – the established authoritative body responsible for evaluating the safety and efficacy of newly developed drugs – granted accelerated approval to ADUHELM because it concluded the drug was “reasonably likely” to provide clinical benefit. This process was approved by Congress, and the FDA has employed it hundreds of times to accelerate access to cancer, HIV and other therapies. CMS has never refused to cover a drug approved through this mechanism when coverage was for use consistent with the FDA label.

This preliminary ruling throws patient access out the window for most Americans. 13 percent of Black and Hispanic Americans over the age of 65 are thought to have Alzheimer’s or related dementias. These communities are two-to-three times and one-and-one-half times more likely to develop the disease, respectively. Without access to the only approved disease modifying treatment for Alzheimer’s, disease prevalence amongst Black and Hispanic Americans will increase unabated, reaching 6 million individuals by 2060. Additionally, at a time when Americans are being hit hard by the COVID-19 pandemic and the resulting economic impacts, this decision fails to bring a sense of economic and health security back to a country in need. The average American can’t afford to pay high out-of-pocket costs for a medicine like ADUHELM when their wallets are already being drained by everyday costs.

It’s imperative that CMS recognize the error in its ways and alter this ruling come April when a permanent decision on the matter is expected. The Biden Administration has failed to live up to its word and is jeopardizing the health of the American people to presumably lower costs. We must hold them accountable.”

Global Alzheimer’s Platform Foundation® Applauds Biogen for Reducing Cost of ADUHELM

GAP Renews Its Call for CMS to Cover the New Class of Drugs for the Treatment of Alzheimer’s

Washington, D.C. (December 20, 2021) – John Dwyer, President of the Global Alzheimer’s Platform Foundation® (GAP), a person-centric non-profit organization committed to accelerating the discovery of therapies for the treatment of Alzheimer’s, issued the following statement on the announcement today by Biogen Inc. that it would reduce the cost of their Alzheimer’s treatment ADUHELM® by nearly 50%. This cost-reduction is the first of several steps that are required to effectively give access to the first FDA approved therapy for Early Alzheimer’s, a disease that afflicts millions of Americans.

“Biogen’s announcement that it would be lowering the cost of ADUHELM by 50% opens the door for treatment access for all Alzheimer’s patients – especially those in medically underserved communities that are disproportionately affected by Alzheimer’s.

GAP has been in the vanguard of patient advocacy groups calling for Biogen to reduce the price of ADUHELM. The price change announced Monday is nearly unprecedented, and we want to thank Biogen for listening to patients, their caregivers, and the entire Alzheimer’s community.

Over 80 percent of those eligible for ADUHELM and similar therapies in the U.S. receive their health insurance through Medicare. But Medicare is still evaluating whether ADUHELM will be covered under its policy. With this price change, the time has come for Medicare to also listen to the needs of Alzheimer’s patients. ADUHELM is an FDA approved treatment – the first in nearly 20 years for people with early Alzheimer’s, a progressive and fatal disease – and it’s imperative that it be covered under Medicare programs.

Numerous similarly FDA approved therapies for cancer, HIV, multiple sclerosis, and other diseases were afforded coverage by CMS, allowing physicians, patients, and their families to make informed decisions as to whether the drug was right for them, without fear of having payment for the treatment denied by Medicare.

To make matters worse, recently the Centers for Medicare & Medicaid Services (CMS) took the unprecedented step of blaming Alzheimer’s patients for a planned Part B premium increase. The fine print of the CMS announcement cited numerous items that might also be causes of the increase. If the CMS actuary believes ADUHELM costs are a primary reason for the premium increase, then logic dictates that Biogen’s reduced price and low estimate of patients on the drug in 2022 requires CMS to reverse its planned increase while covering ADUHELM. 57 million Medicare beneficiaries are going to experience a premium increase that is financially unwarranted and that stigmatizes Alzheimer patients.

For the first time in nearly 20 years, Alzheimer’s patients have an FDA approved therapy — a therapy for a condition that has no other treatment. Biogen has substantially reduced the drug’s price. It is now time for CMS to cover this drug, as it has before for other diseases, so that millions of Alzheimer’s patients might benefit. Do not make us wait any longer.”

Atlanta Metro Communities Gain Access to Renowned Alzheimer’s Research Network Through Local Clinical Trial Site

iResearch Atlanta will join the Global Alzheimer’s Platform Foundation®’s network (GAP-Net) of clinical trial sites working to bring new treatments to those living with the disease and and improve equity in research.

Contact: Peter Buonanno – [email protected] – 704.989.5501

WASHINGTON, D.C. (December 7, 2021) – The Global Alzheimer’s Platform Foundation® (GAP) announced that iResearch Atlanta will join its network of clinical trial sites (GAP-Net), a team of leading academic and private research sites collaborating to accelerate the delivery of innovative therapies for neurological disorders by reducing the duration and cost of clinical trials and improving equity in trial recruitment. As a GAP-Net member, iResearch Atlanta will continue to make a difference in its local community as they conduct research studies of new treatments and therapies medications for illnesses affecting the Atlanta community, including Alzheimer’s disease.

“iResearch Atlanta will help increase the availability of Alzheimer’s clinical trials in a quickly-growing market with a high prevalence of the disease,” said John Dwyer, President of GAP. “The teams at iResearch Atlanta will specifically help bring clinical trials to people from traditionally underrepresented communities in the area.”

Across the country, Black Americans are between two-and-three times more likely to develop Alzheimer’s in their lifetimes. At the local level, 50% of Atlanta residents identify as Black or African American. Additionally, there are an estimated 150,000 people living with Alzheimer’s in Georgia – and that number is expected to increase to 190,000 by 2025. iResearch has a proven capability to fill studies quickly through extensive community engagement and is committed to enrolling participants from a broad demographic range to ensure that future treatments are sensitive and specific to all people.

“iResearch Atlanta is led by dedicated, experienced research professionals who are committed to conducting clinical trials which help bring effective treatments to our local and global communities while ensuring that study participants have a customized and respectful experience,” said Heather Beitz, co-owner of iResearch Atlanta. “Collaborating with other GAP-Net sites who share our values will help us alter the clinical trial landscape in the U.S. through improved and intentional recruitment, and unbiased data collection.”

iResearch Atlanta is a multi-specialty clinical research center in Decatur, GA outside of Atlanta. The center was founded in 2010 by Heather Beitz, Chief Executive Officer and Clinical Operations Director, and Sara Castle, Chief Operations Officer. The center’s team is composed of practitioners with extensive experience in pharmaceutical and medical device research across a wide range of therapeutic areas, including major neurocognitive disorders like Alzheimer’s disease and Parkinson’s disease.

Those interested in enrolling in an Alzheimer’s clinical trial at iResearch can and its reach can visit www.iResearchAtlanta.com or email [email protected].

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About the Global Alzheimer’s Platform Foundation® (GAP)

The Global Alzheimer’s Platform Foundation® (GAP) is a person-centric nonprofit dedicated to accelerating the delivery of innovative therapies for neurological disorders by reducing the duration and cost of clinical trials. Research centers across the US, Canada, and Europe are part of the growing GAP Network (GAP-Net). GAP supports GAP-Net research centers by assisting with study start up and recruitment activities, promoting diversity in research studies, and offering national programs that champion brain health and the citizen scientists who make research possible.

Ixico and GAP Partner Interview

Watch GAP President John Dwyer and GAP’s Senior Advisor, Dr. Lynne Hughes, talk about our Ixico partnership and our Bio-Hermes study.

Orlando Seniors Gain Access to Innovative Alzheimer’s Clinical Trial

Study leaders at new Global Alzheimer’s Network Site Commit to Improving Equity in Florida Alzheimer’s Research

Contact: Peter Buonanno – [email protected] – 408-466-5952

Washington, DC (November 18, 2021) – With enrollment in full swing, the Global Alzheimer’s Platform Foundation® (GAP) has announced that K2 Medical Research will join both their GAP-Network of clinical trial sites the team of leading researchers collaborating on the groundbreaking Alzheimer’s Bio-Hermes Study. Bio-Hermes, which seeks to discover cost-effective Alzheimer’s assessment tools, has made the landmark commitment to enroll at least 20% Black/African American and Hispanic/Latino study participants. This level of commitment to a diverse study pool is rarely achieved in medical research (4x the national average), and the study is well on its way towards meeting the recruitment goal.

Orlando seniors who enroll in Bio-Hermes at K2 will receive a study-related PET scan, the gold standard for an Alzheimer’s diagnosis, at no cost to them. This study provides an opportunity for Orlando’s Black and Hispanic seniors to assess their brain health given that they are less likely to receive a timely Alzheimer’s diagnosis despite being more likely (1.5x and 3x respectively) to develop the disease.

“The addition of the K2 site to Bio-Hermes comes at a critical point in the study’s progression,” said John Dwyer, the President of the Global Alzheimer’s Platform Foundation, the sponsor of the Bio-Hermes study. “As our researchers near the diversity recruitment goal, there is tremendous interest from study participants – especially in central Florida where K2 is located – in Bio-Hermes. K2 will provide access to unique clinical information and research for Orlando area seniors, and we are calling on all of those interested to enroll in the study (whether you are living with Alzheimer’s, have memory concerns, or are completely healthy), Dwyer concluded.

“At K2 we believe that, by focusing on the basics of excellent care, we can breathe new life into Alzheimer’s research – improving the clinical trial experience for everyone involved and potentially transforming how studies are designed and managed,” said Dr. Sheila Baez-Torres of K2 Medical Research. “We hear every day from folks of all backgrounds just how impactful their experience at K2 was during their care journey. The Bio-Hermes Study has the potential to improve the quality of care available to traditionally underrepresented folks and participants will be treated with respect and warmth.”

The K2 clinical team – led by founder Sean Stanton and Bio-Hermes principal investigator Dr. Sheila Baez-Torres – has a combined 70+ years of experience in medical research. The leaders of K2 offer clinical trials as a practical part of the health journey for the local community and those living with Alzheimer’s. And they are committed to improving enrollment from people who are traditionally underrepresented in clinical trials to help make sure that all future Alzheimer’s treatments, therapies, and cures are sensitive and specific to all people.

The K2 team has completed over 5,000 clinical trials – in therapeutic areas from Liver Disease to rare diseases and neurodegenerative diseases like Alzheimer’s and Parkinson’s.

“We need people with memory concerns or those who are at risk of developing Alzheimer’s to enroll in clinical trials,” said John Dwyer, President of GAP. “Bio-Hermes is not an ordinary clinical trial. People who enroll will have a personalized and positive experience. We are proud of our progress thus far and are confident that the fantastic researchers at K2 Medical research will contribute to paving the way for a new industry standard in how clinical trials are run and how participants are included.”

Those interested in learning more about the Bio-Hermes study can visit GAP’s landing page or call K2 Medical Research at (407)-500-5252.

### About the Bio-Hermes Study ###

Bio-Hermes is the first-ever platform study to compare the results of blood and digital biomarker tests, including digital cognitive and voice assessments, with the results of brain amyloid PET scans and traditional cognitive tests. GAP’s Bio-Hermes Study database will allow scientists to assess the ability of each biomarker, or combination of biomarkers, to prognosticate the accumulation of amyloid in the brain – a hallmark of Alzheimer’s. Use of biomarkers could lead to earlier and more frequent detection of amyloid in the brain, prompting those affected to seek early intervention, leading to higher quality of care for those living with the disease.

### About the Global Alzheimer’s Platform Foundation® (GAP) ###

Alzheimer’s Research Center Focused on Hispanics Opens in Texas

New GAP-Net site El Faro Health and Therapeutics has opened in Rio Grande City, TX.

The below article was translated from Spanish to English. The original, Spanish version is linked at the bottom.

A new clinical research center to study Alzheimer’s and its impact among Hispanics, the group with the highest prevalence of this disease in the U.S., opened this past Saturday in the border city of Rio Grande, Texas.

With the opening of this research center, El Faro is also launching the first phase of a clinical study about the impact of this disease among Hispanics over the age of 65 residing in this border region, which has a population that is 97% Hispanic.

Doctor Tony Falcon, who developed this research center in collaboration with the Global Alzheimer’s Platform Foundation, explained to EFE that this study will focus on senior Hispanics who speak both English and Spanish, a group that has been insufficiently studied.

“These clinical studies focused on the Hispanic population in Rio Grande will help us to better understand the health and risk factors of this specific group”, said Falcon, who also highlighted that the objective of this research project is to identify “ways to prevent and diagnose early-stage Alzheimer’s among Hispanics.”

Rio Grande is a city located on the banks of the Rio Bravo (as it’s known in northern Mexico), in Starr County, and a large proportion of its adult population speaks both languages, said Falcon.

The prevalence of Alzheimer’s among Hispanics in the United States has raised concerns among experts.

In 2018 the Centers for Disease Control and Prevention (CDC) warned that by 2060 the total number of Hispanics above 65 years will quadruple, and Hispanics will face the largest increase in Alzheimer’s and associated dementia conditions of any ethnic/racial group in the country.

Given that aging is the main risk factor connected to Alzheimer’s disease, it is expected that there will be more Hispanics suffering from this condition in the coming years: roughly 3.5 million in the United States by 2060.

Falcon underscored that, beyond age, other factors can increase the risk of Alzheimer’s among Hispanics, including low socioeconomic status and a larger prevalence of medical conditions such as diabetes, high blood pressure, obesity, and depression.

Hispanics also tend to develop symptoms at a younger age than Whites and other groups.

The doctor of Mexican heritage said he expects this first clinical study will open the way for other studies focused on the Hispanic community.

Originally posted by HolaNews.com on November 13, 2021.

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