Great Lakes Clinical Trials: An independent phase I-IV clinical trial center

By: The Chicago Doctor
December 2, 2015

Every medication currently available by prescription has gone through an extensive clinical trial process. Hundreds of thousands of patients across the country have volunteered to participate in research so that these medications can be available for future generations.  Chicago now has a world-class, internationally-recognized research clinic to run these important programs, located on the Northside of the city – Great Lakes Clinical Trials.

The team at Great Lakes Clinical Trials’ state-of-the-art facility have conducted more than 450 clinical research studies in indications ranging from: Alzheimer’s Disease (AD), Osteoarthritis, Complex Regional Pain Syndrome, Depression, Migraine and Parkinson’s Disease.  Founder Steve Satek, who has over 25 years’ experience and is a well-known specialist in the field of clinical research, brought together seasoned experts to open the clinic.  Their founding philosophy is to remain patient-focused, with impeccable quality.

Great Lakes Clinical TrialsThe team at Great Lakes Clinical Trials includes five board-certified physicians and a neuropsychologist who are focused 100% on conducting clinical research.  This means the clinic does not maintain a private practice.  “We do not have a billing department at Great Lakes Clinical Trials,” commented Satek. “All our trials are free-of charge to our patients and truly complement hospital and private practices across the city.   This allows us to be totally patient-focused and referring physicians are not concerned about losing their patients to another practice.”  The concept implemented by Great Lakes Clinical Trials is that access to research trials should be available to all clinicians across the region.  The referral process should be easy and Great Lakes Clinical Trials takes the necessary steps to keep the referring physicians informed of their patients’ progress throughout the clinical trial.

Alzheimer’s disease is at the forefront of Great Lakes Clinical Trials research. This is an exciting time to be involved in Alzheimer’s research.  There hasn’t been a new Alzheimer’s medication approved since 2003 and the currently available medications only treat the symptoms of the disease.  The new wave of medications being researched are actually ‘disease modifying compounds’ which target the source of disease itself.  With today’s PET scan technology, researchers are able to see who is already at risk of developing the disease and whether the compound is working or not.

Great Lakes Clinical Trials is also actively conducting a trial in major depressive disorder.  The research focuses on a novel medication with an expected immediate onset of action.  “This is also an exciting time in depression research,” said Satek.  “We haven’t seen significant breakthroughs since the days of SSRIs and SNRIs being approved.”

As a private, community-based clinic, Great Lakes Clinical Trials is changing the landscape of research in the Chicago area.  To learn more about the studies being conducted at Great Lakes Clinical Trials and how to refer your patients for participation, visit its website at www.greatlakesclinicaltrials.com or call (773) 275-3500.

You can view the original TheChicagoDoctor.com article here.

Alzheimer's: A Disease On Track to Bankrupt Medicare

by CNBC.com
Nov 10 2015, 11:16 am ET

Leading Alzheimer's researchers are optimistic that effective treatments to significantly slow or even halt the symptoms of this agonizing and ultimately fatal disease will be available within the next five years.

The hope springs from important breakthroughs on several fronts. Advances in high-powered imaging through PET (positron emission tomography) scans are giving researchers better diagnostic tools with which to view the brain. And a renewed interest in different brain proteins is providing greater clues as to which ones are responsible for kick-starting this devastating disease in the first place.

These discoveries have led to a flurry of clinical trials and studies now under way, and that's good news for Alzheimer's patients. Researchers say the work being done today could bring about a host of new drugs to treat the disease better and more effectively than anything currently on the market. These new therapies could potentially stop the progression of the disease before symptoms, like memory loss and confusion, ever start — something that's not possible with the drugs now being prescribed.

Says Dr. Marc Diamond, founding director of the Center for Alzheimer's and Neurodegenerative Diseases at the University of Texas Southwestern and one of the leading voices on Alzheimer's research: "It's an incredibly exciting time right now."

A Devastating Disease

To truly understand just how catastrophic an illness Alzheimer's is, consider that it is the only cause of death among the top 10 in the U.S. that can't yet be prevented, cured or even slowed. Someone diagnosed with cancer, heart disease or even HIV/AIDS has a better chance of surviving — and having a better quality of life while battling the disease — than a person diagnosed with Alzheimer's.

According to the Alzheimer's Association, there are now 5.3 million Americans age 65 and older living with the disease. The total direct cost to the U.S. economy of caring for those with Alzheimer's: a staggering $226 billion, with half being borne by Medicare.

Delaying the onset of the disease by just five years, research studies show, could decrease Medicare spending by 50 percent. That's an important point to consider, because economists forecast that unless something is done to cure or even slow the symptoms, the number of people with Alzheimer's will rise to 16 million by 2050 and cost the U.S. economy $1.1 trillion. The portion covered by Medicare will balloon to $589 billion.

Closer to home, the financial burden of caring for someone with Alzheimer's can be devastating. According to a recent study by the Annals of Internal Medicine, the cost of caring for a person with Alzheimer's in the last five years of life is $287,038.

That's far higher than the costs incurred for a person who died from cancer or heart disease. The reason: Alzheimer's patients need the kind of care at the end of their lives — bathing, dressing and eating — that's not covered by insurance. This puts a tremendous burden on a spouse or, in many cases, adult children who may be trying to save for their own retirement or have college tuitions to pay.

One point that all the experts we spoke with agree on is that federal funding for Alzheimer's research needs to increase — and soon. Currently, just under $1 billion a year is allocated for Alzheimer's research. That's far less than the $5 billion spent on cancer or the $3 billion on HIV/AIDS research, according to the Alzheimer's Association.

"This is clearly the underfunded and understudied problem of the 21st century," says Dr. Bruce Miller, director of the Memory and Aging Center at the University of California, San Francisco. "We've made a lot of progress in therapies around heart disease, cancer and stroke, and we need to move faster in Alzheimer's research. If we can't find better therapies for an aging brain, as a society we will dramatically suffer."

A Lack Of Effective Drugs

The FDA-approved drugs now on the market and most widely prescribed to treat Alzheimer's — Aricept and Namenda — are helpful but limited, doctors say. "What's available now are symptomatic treatments that simply give a patient maybe six to 12 months of doing just a little bit better," says Dr. Reisa Sperling, a leading Alzheimer's researcher and professor of neurology at Harvard Medical School. Even the newest drug on the market — Namzaric — is basically a combination of two existing drugs and claims only to slow the worsening of symptoms for a while. Like Aricept and Namenda, Namzaric has no effect on stopping or preventing the underlying disease.

But now it seems like the focus — and promise — of Alzheimer's research is beginning to shift. For the past two decades the main target in research has been an influential brain protein called beta-amyloid. Over time this protein can build up outside the brain's neurons and form what's known as amyloid plaque. The hypothesis for decades has been that it's this plaque buildup that ultimately leads to Alzheimer's in certain patients.

As a result, the overwhelming focus in the field has been on beta-amyloid. "For the past 15 or 20 years, if a researcher was not studying beta-amyloid, the chances of getting funding or grant money was quite low," says Dr. Jim Sullivan, vice president of discovery for AbbVie, a pharmaceutical company involved in Alzheimer's research.

The problem with this singular approach is that, in patients with moderate to severe Alzheimer's symptoms, lowering beta-amyloid levels does not make a difference in the severity of the disease or its progression. Further complicating the picture is the fact that, thanks to the brain images now possible with PET scans, it has been proved that individuals can have significant levels of amyloid in their brain and not show signs of Alzheimer's or any other type of dementia.

Leading Alzheimer's researchers are optimistic that effective treatments to significantly slow or even halt the symptoms of this agonizing and ultimately fatal disease will be available within the next five years.

The hope springs from important breakthroughs on several fronts. Advances in high-powered imaging through PET (positron emission tomography) scans are giving researchers better diagnostic tools with which to view the brain. And a renewed interest in different brain proteins is providing greater clues as to which ones are responsible for kick-starting this devastating disease in the first place.

These discoveries have led to a flurry of clinical trials and studies now under way, and that's good news for Alzheimer's patients. Researchers say the work being done today could bring about a host of new drugs to treat the disease better and more effectively than anything currently on the market. These new therapies could potentially stop the progression of the disease before symptoms, like memory loss and confusion, ever start — something that's not possible with the drugs now being prescribed.

These findings have ignited renewed interest in other cognitive culprits; chief among them is another brain protein, called tau. Unlike beta-amyloid, which forms and builds up outside the neurons in the brain, tau develops inside the neurons. From there it can do its damage by traveling to neighboring cells and acting as a sort of virus that corrupts the normal protein of these other cells. For this reason, researchers believe tau may play an even more direct and influential role than beta-amyloid in the development of Alzheimer's and other forms of dementia.

Diamond of the University of Texas describes the relationship between these two proteins this way: "If [beta-amyloid] unlocks the barn door and let's the tau out, then tau is the horse that goes running off," he says. "It's the progression of tau as it moves through your brain that actually causes Alzheimer's dementia, but it's the [beta-amyloid] that sets you up to get that pathology."

Searching For A Better Treatment

If the past several decades were focused on developing drugs that might improve life for patients with symptoms of Alzheimer's, current research is all about arresting — or even preventing — the disease before the first symptoms ever appear. Says Miller of UC San Francisco: "We know now that prevention of this disease is feasible and something our field will conquer."

In other diseases, such as certain types of cancer or heart disease, genetic screenings are often the first line of defense. However, that approach is hotly debated when it comes to screening for Alzheimer's. "I don't think we should be screening for the presence of beta-amyloid in the general population until we have something effective to offer people," says Sperling.

In the case of individuals with a family history of Alzheimer's, the testing may be warranted, Miller says. But he adds it still leads to an uneasy choice. "There are those individuals who might argue that it's a person's right to know if they're going to get the disease," he says.

And then there are doctors who argue that giving people this information does not improve the quality of life but in fact worsens it, because there are no effective treatments to stop the disease, he adds.

In the meantime, multiple studies and trials involving both tau and beta-amyloid are now under way to figure out how to prevent Alzheimer's. On the tau front, pharmaceutical company AbbVie and C2N Diagnostics are in Phase 1 of a clinical trial to test a tau antibody in patients with progressive supranuclear palsy (PSP), a neurological disease closely related to Alzheimer's. Early next year, the company will start Phase 1 testing of the antibody with Alzheimer's patients. The goal, says Sullivan, is to slow down the progression of the disease by blocking the spread and accumulation of tau in the brain.

At Harvard, Sperling is the project leader for a clinical study that is exploring if lowering beta-amyloid buildup in otherwise healthy patients with no memory loss can prevent Alzheimer's from developing down the road. The so-called A4 study (Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease) is a public/private partnership between the National Institutes of Health (NIH) and pharmaceutical company Eli Lilly and will include approximately 1,000 people ages 65 to 85 over the next three and a half years.

Half the group will receive the drug being tested, and half will get a placebo. Every six months, patients will undergo cognitive testing to see if there is any difference in their memory and recall. At three points during the study, they will have a brain PET scan to see if their amyloid buildup has changed.

"This is analogous to what we do with cholesterol, by trying to do things that keep it in check so that we can prevent heart attacks and strokes before they happen," Sperling says.

Whether it's through the tau protein or beta-amyloid, preventing Alzheimer's is the major focus of researchers today. "I think our best bet with Alzheimer's is to act before there are symptoms," she says. "Because by the time that happens, there's more than just a head full of amyloid. There's already loss of key neurons and brain shrinkage that we're not going to be able to bring back."

— By Susan Caminiti, special to CNBC.com

Great Lakes Clinical Trials - Alzheimer's Research Specialists

What is Complex Regional Pain Syndrome?

Complex Regional Pain Syndrome (CRPS) is a chronic pain condition most often affecting one of the limbs (arms, legs, hands, or feet), usually after an injury or trauma to that limb.  CRPS is believed to be caused by damage to, or malfunction of, the peripheral and central nervous systems.  The central nervous system is composed of the brain and spinal cord, and the peripheral nervous system involves nerve signaling from the brain and spinal cord to the rest of the body.  CRPS is characterized by prolonged or excessive pain and mild or dramatic changes in skin color, temperature, and/or swelling in the affected area.

There are two similar forms, called CRPS-I and CRPS-II, with the same symptoms and treatments. CRPS-II (previously called causalgia) is the term used for patients with confirmed nerve injuries. Individuals without confirmed nerve injury are classified as having CRPS-I (previously called reflex sympathetic dystrophy syndrome).  Some research has identified evidence of nerve injury in CRPS-I, so the validity of the two different forms is being investigated.

CRPS symptoms vary in severity and duration. Studies of the incidence and prevalence of the disease show that most cases are mild and individuals recover gradually with time. In more severe cases, individuals may not recover and may have long-term disability.

"Complex Regional Pain Syndrome Fact Sheet," NINDS. Publication date June 2013.

NIH Publication No. 13-4173

Steve Satek, Great Lakes Clinical Trials President, Rallies the Crowd at the 2015 Chicago Walk to End Alzheimers

Great Lakes Clinical Trials had the honor of being a sponsor of the 2015 Chicago Walk to End Alzheimer's held on September 27th on the Chicago Lakefront.   Over 5,000 walkers participated in the event which aims to raise $1 million for Alzheimer's research.

Erna E. Colborn, President and CEO of Alzheimer's Association, Greater Illinois Chapter introduced Steve Satek, Great Lakes Clinical Trials President at the event.  Steve had the honor of addressing all the participants just before the start of the walk and present a case for increasing participation in clinical trials.

Depression Treatments Inspired By Club Drug Move Ahead In Tests

Experimental medicines related to ketamine, an anesthetic and club drug, are making progress in clinical tests.

Article from NPR.org
May 28, 201511:29 AM ET
Jon Hamilton, Correspondent, Science Desk

Antidepressant drugs that work in hours instead of weeks could be on the market within three years, researchers say.

"We're getting closer and closer to having really, truly next-generation treatments that are better and quicker than existing ones," says Dr. Carlos Zarate, a researcher at the National Institute of Mental Health.

The new drugs are based on the anesthetic ketamine, which is also a popular club drug known as Special K. Unlike current antidepressants, which can take weeks to work, ketamine-like drugs have an immediate effect. They also have helped people with depression who didn't respond to other medications.

The drug that is furthest along is esketamine, a chemical variant of ketamine that has been designated a potential breakthrough by the Food and Drug Administration. Esketamine is poised to begin Phase 3 trials, and the drug's maker, Johnson & Johnson, plans to seek FDA approval in 2018.

Can Ketamine Keep Depression At Bay?

Another ketamine-like drug on the horizon is rapastinel. It has completed Phase 2 studies, which showed "rapid, substantial, and sustained reductions in depressive symptoms," according to the drug's maker, Naurex.

"I think it's highly probable that we'll see some version of one of these treatments being approved in the relatively near future," says Dr. Gerard Sanacora, director of the Yale Depression Research Program. "In my mind it is the most exciting development in mood disorder treatment in the last 50 years."

Sanacora has done consulting work for both Naurex and Johnson & Johnson. He is also an investigator for a study in which esketamine will be given to suicidal patients.

'I Wanted To Live': New Depression Drugs Offer Hope For Toughest Cases

The new drugs come nearly a decade after Zarate and other researchers from the National Institutes of Health published a study showing that ketamine helped most people with major depression in less than two hours. "When we saw the first initial responses you say, wow, this will definitely revolutionize our treatments for mental illness," Zarate says.

Since then, many other studies have confirmed that ketamine usually works even when other drugs have failed. "At this point I think it's incontrovertible that the drug has clear, robust rapid antidepressant effect," Sanacora says. Studies suggest that effect usually lasts for a week or so.

But ketamine itself has shortcomings. It can cause hallucinations, and it's a drug that is frequently abused.

Also, from the perspective of drug companies, ketamine is problematic because it is already available as an inexpensive generic drug. So companies including Naurex and Johnson & Johnson began searching for compounds they could patent that would have a similar effect in the brain.

If esketamine and repastinel reach the market, they could be blockbuster sellers. Johnson & Johnson included esketamine on a list of drugs with potential annual sales of more than $1 billion.

In the meantime, many psychiatrists are already prescribing ketamine to severely depressed patients who haven't been helped by other drugs, even though ketamine hasn't been approved by the FDA for that purpose. This sort of "off-label" prescribing is common in psychiatry, Zarate says.

"I don't think it's necessarily irresponsible," says Sanacora, who has prescribed off-label ketamine to some of his own patients. But it's important that patients who get the drug understand that it's still experimental and are warned of potential risks. He also recommends that patients who want to try ketamine enter a clinical trial.

One looming question about all the ketamine-like drugs is whether they will be safe and effective after months or years of use. "Maintaining is going to be key," Zarate says.

Premier Pain Specialists - A Great Lakes Clinical Trials Partner

A new video has recently been produced describing the activities at Premier Pain Specialists.  We collaborate closely with Dr. Kiran Chekka and his Premier Pain team on ALL our pain research projects at Great Lakes such as hip/knee pain, fibromyalgia, migraine and Complex Regional Pain Syndrome (CRPS).  Premier Pain Specialists is the largest private pain clinic in the State of Illinois and we are very lucky to be working with such a quality team.  If you want to learn more about our pain research programs, call us at (773) 275-3500 or fill out a contact form by clicking here.

Premier Pain Specialists in Chicago offers 8 locations throughout the Chicago metropolitan area.  All of the doctors are Board Certified and Fellowship Trained, offering both medication management and interventional procedures.

Great Lakes Clincial Trials Hosts ACRP Certification Preparation Course

On Saturday, August 1, 2015 Great Lakes Clinical Trials hosted a certification preparation course for the Association of Clinical Research Professionals (ACRP). 

"I'm proud that Great Lakes Clinical Trials was able to host this important event," commented Steve Satek, GLCT President.  "Great Lakes Clinical Trials is committed to the conduct of quality clinical research, which aligns well with the mission of ACRP and the certification process."

The day-long event, held in the Great Lakes Clinical Trials Conference Facility in Chicago,  brought together research colleagues from across the globe to help in prepare for ACRP Certification.   Certification is the formal recognition of clinical research professionals who have demonstrated the knowledge, skills, and abilities to perform ethical and responsible clinical research by passing one of three role-specific certification exams based on international standards.

ACRP offers 3 certification programs:

• Certified Clinical Research Associate (CCRA):  A CRA monitors the administration and progress of a clinical trial on behalf of a sponsor. A CRA must be independent of the investigative staff conducting the research at the site or institution. The CCRA credential is awarded to a CRA who has passed the standardized ACRP CRA Certification exam.
   
• Certified Clinical Research Coordinator (CCRC):   A CRC works at a clinical research site with study subjects under the immediate direction of an investigator whose research activities are conducted under GCP Guidelines. The CCRC credential is awarded to a CRC who has passed the standardized ACRP CRC Certification exam.
   
• Certified Principal Investigator (CPI):  A PI holds a doctoral-level degree (PhD, PharmD, DNP, DO, MD, DDS or equivalent degree) and serves as the primary, sub-, or co-investigator on a clinical trial. A PI accepts responsibility for the safe and ethical conduct of a clinical trial. The CPI credential is awarded to a PI who has passed the standardized ACRP PI Certification exam.

ACRP Certification is making a difference in clinical research, driving site efficiency, establishing professionalism, setting the standard for quality, and defining the future of ethical, responsible clinical research. By committing to ACRP Certification, participants promote professionalism, validating of competence, and dedication to quality standards.

A Simple 3-Part Test May Predict Alzheimer’s

Dementia is a part of aging, but how do doctors separate normal brain decline from the first signs of Alzheimer’s? A new test that any physician can perform in their office may help.

Diseases like Alzheimer’s start years, even decades, before the first symptoms of memory loss shows up. And with rates of those diseases rising, experts say that more primary care physicians—not neurology experts—will have the task of identifying these patients early so they can take advantage of whatever early interventions might be available.

“If we had a simple blood test, a cholesterol test for Alzheimer’s disease, that would help,” says Dr. Ronald Petersen, director of the Alzheimer’s Disease Research Center at the Mayo Clinic, “but we don’t.” But Petersen has a potential solution, and according to a new paper released Wednesday in the journal Neurology, his Alzheimer’s test has promise.

Petersen and his team wanted to develop a test that any physician can administer to patients, without the need for any new technology or expensive equipment. Petersen believes that the test they came up with could become a useful tool for any physician, even those without special training in the brain. “What we are trying to do is give them some help so they can be as efficient as possible without ignoring these important cognitive issues,” he says.

In the first phase of the test, his researchers simply collected information from 1,500 patients’ medical charts—their age, family history of Alzheimer’s, factors such as diabetes or smoking that have been linked to Alzheimer’s, and whether the patient had ever reported problems with memory.

In the next phase they studied the results of the patient’s basic mental exam as well as of a psychiatric evaluation, because depression and anxiety have been connected to Alzheimer’s.  And another factor that emerged as important in developing the disease—how quickly the participant could walk a short distance. “We were a little surprised,” says Petersen. “But what’s nice about it is that it’s a nice non-cognitive, motor factor so it’s looking at another aspect of brain function.”

Petersen suggests that every physician should get this information on their patients at age 65; that way, they can have a baseline against which to compare any changes as their patients age. Only if they show such changes — a slower walk, for example, or worsening signs of depression or memory issues — should they move on to the third phase of the test, which is a blood analysis. That would look for known genetic factors linked to Alzheimer’s, including the presence of certain versions of the ApoE gene.

Currently, the only way to truly separate out those on the road to Alzheimer’s is to conduct expensive imaging tests of the brain, or to do a spinal tap, an invasive procedure that extracts spinal fluid for signs of the amyloid protein that builds up in the disease. “We have either expensive techniques or invasive techniques and it’s not practical to do them from a public health screening standpoint,” says Petersen.

While his test is a possible solution to that problem, he acknowledges that the results need be repeated before it’s recommended on a wide scale to physicians across the country. But those who scored higher on the test of risk factors had a seven-fold higher chance of developing mild cognitive impairment than those with lower scores.

For now, even if doctors identify patients around age 65 who might be at higher risk of developing cognitive impairment, there isn’t much they can do to interrupt the process. But they can direct them toward clinical trials of promising new drugs to address Alzheimer’s dementia, which may slow the cognitive decline considerably.

Alice Park, "A Simple 3-Part Test May Predict Alzheimer’s," Time Magazine, March 18, 2015, http://time.com/3749130/alzheimers-test-dementia/

vTv Therapeutics Initiates Pivotal Phase 3 Trial Evaluating Azeliragon for the Treatment of Patients with Mild Alzheimer’s Disease

Completed Phase 2 Trial Showed Positive Results Combating Alzheimer’s Disease 

High Point, North Carolina (May 19, 2015)

vTv Therapeutics LLC (vTv) today announced  enrollment of the first patients into STEADFAST (Single Trial Evaluating Alzheimer’s Disease Following Addition to Symptomatic Therapy), vTv’s Phase 3 placebo controlled trial of azeliragon, an oral antagonist of the Receptor for Advanced Glycation Endproducts (RAGE) for treatment of mild Alzheimer’s disease. Phase 3 begins following a Phase 2 trial that demonstrated positive results in slowing cognitive decline with 5 mg/day of azeliragon in patients with mild to moderate Alzheimer’s Disease.

“We are excited to reach this next significant milestone in the development of azeliragon as a potential therapy to slow the decline of cognition and function in patients with Alzheimer’s disease by enrolling our first patients in our phase 3 trial,” said Steve Holcombe, President and CEO of vTv.  “There remains a critical need for the development of new treatments for this devastating disease.  Azeliragon’s novel mechanism allows for targeting a receptor we believe is involved in multiple pathologic processes leading to the development and progression of Alzheimer’s disease.” 

The STEADFAST Study will investigate the efficacy of azeliragon compared with placebo in the treatment of patients with mild Alzheimer’s disease already receiving cholinesterase inhibitors and/or memantine.

vTv is actively recruiting and enrolling new patients for the STEADFAST Study. Physicians and researchers looking for more information about the trial can visit www.livingsteadfast.com or call 336-841-0300 ext 120.

About the STEADFAST Study

STEADFAST is a randomized, double-blind, placebo-controlled Phase 3 study that is investigating the efficacy of Azeliragon as a potential disease modifying therapy for patients with mild Alzheimer’s disease. The trial targets enrollment of 800 patients in the United States and Canada who will receive 18 months of treatment. The protocol is being conducted following agreement with FDA under the Special Protocol Assessment (SPA) process. 

About Azeliragon

A broad range of human pathologic and experimental biologic investigation suggests that RAGE activation contributes to the pathogenesis of Alzheimer’s disease. Sustained Amyloid-β interactions with RAGE at the blood-brain barrier (BBB) and in neuronal and microglial cells, play potentially major roles in amyloid plaque formation, neuroinflammation and chronic neural dysfunction – all hallmarks of Alzheimer’s disease.

Azeliragon, also known as TTP488, is a novel orally active small-molecule antagonist of RAGE. In a double-blind Phase 2 clinical trial where data was collected over 18 months, azeliragon 5 mg/day slowed cognitive decline, as measured by the Alzheimer’s Disease Assessment Scale-cognitive cognition (ADAS-cog), in patients with mild to moderate Alzheimer’s disease.  The effect on cognition, statistically significant in patients with mild-to-moderate disease, was more pronounced in patients with mild Alzheimer’s disease.  Additionally, effects were noted on the Clinical Dementia Rating sum of boxes (CDR-sb), a measure of global impairment, in patients with mild Alzheimer’s disease.     vTv discovered and developed azeliragon using its proprietary drug discovery platform TTP Translational Technology®.

About Alzheimer’s Disease

Alzheimer’s disease, the most common form of dementia, is a progressive neurodegenerative disorder that causes decline in cognition and functional abilities. It is estimated to affect 5 million Americans, representing the 6th leading cause of death. Worldwide, there are currently more than 35 million people with dementia and is expected to increase to over 115 million by 2050.

While current approved therapies for Alzheimer’s disease focus on improving the symptoms of the cognitive dysfunction, there is currently no treatment to slow long-term, cognitive decline and disease progression.

About vTv Therapeutics LLC

vTv Therapeutics LLC is a clinical-stage biopharmaceutical company engaged in the discovery and  development of orally administered small molecule drug candidates to fill significant unmet medical needs. vTv has a pipeline of clinical drug candidates led by programs for the treatment of Alzheimer’s disease and type 2 diabetes as the well as treatment of inflammatory disorders and the prevention of muscle weakness. The Company’s drug candidates were discovered with its high-throughput drug discovery platform, Translational Technology®, which translates the functional modulation of human proteins into safe and effective medicines. For further company information, visit www.vtvtherapeutics.com