Great Lakes Clinical Trials Contributes to Successful Migraine Research Program

Great Lakes Clinical Trial staff, under the direction of Medical Director, Jeffrey Ross, MD, are pleased to share the results of Alder Biopharmaceuticals' migraine research program which were released earlier today.  A press release has been issued entitled,

Alder Announces Eptinezumab Significantly Reduces Migraine Risk Meets Primary and All Key Secondary Endpoints in Pivotal PROMISE 2 Phase 3 Trial for Chronic Migraine Prevention

The highlights of the press release include:

Jeffrey Ross, MD
Medical Director

• Highly statistically significant results with rapid prevention beginning Day One
• 50%, 75%, 100% responder rates by month one sustained for three months
• 15% of patients had no migraines for a full three months

To view a full copy of the press release click HERE.

"Our clinic is an independent and unbiased research facility for the testing of investigational medicals for a variety of diseases, including migraines.  Our primary service is for our medical staff to work closely with our patients and determine if a new medication works or not, and assess its safety." commented Steve Satek, Great Lakes Clinical Trials President.  "When we hear positive results from research programs which we conducted on such as this Alder Biopharmaceuticals migraine program, it reaffirms our company's mission to advance the science of medicine and  improve the quality of life and health of patients around the world.

All services at Great Lakes Clinical Trials are provided at no cost and are conducted by board-certified physicians.  No insurance required.  For a full listing of studies currently being conducted at Great Lakes Clinical Trials, visit our Studies page by clicking here.

Help Preserve Memories: Participate in Research

If you or someone you know is over the age of 60 and has a family history of Alzheimer's disease, you can help join the fight to find a cure for future generations.

Great Lakes Clinical Trials is committed to finding a cure for Alzheimer's Disease, but this cannot be done without the participation of our senior community in clinical trials. 

Bill Gates Donates $100 Million to Help Find a Cure for Alzheimer's Disease

"My family history isn’t the sole reason behind my interest in Alzheimer’s. But my personal experience has exposed me to how hopeless it feels when you or a loved one gets the disease. We’ve seen scientific innovation turn once-guaranteed killers like HIV into chronic illnesses that can be held in check with medication. I believe we can do the same (or better) with Alzheimer’s."
Bill Gates, 2017

For more information about Bill Gates' commitment to fight Alzheimer's, click here.

 

To learn more about how you can participate in a research study at Great Lakes Clinical Trials, click the button below.

Pre-Diabetes: Are You at Risk?

By ABC NEWS  July 30, 2017

Is diabetes knocking at your door? It is for millions of Americans. In fact, it's the fourth-leading killer in the country. But with proper identification of those with a condition dubbed "pre-diabetes," the full-blown version of the illness can be turned away.

An estimated 16 million Americans have pre-diabetes, on top of the 17 million estimated to have already developed diabetes. Pre-diabetes, a term coined earlier this year as part of an ongoing prevention campaign, describes a condition previously known as impaired glucose tolerance.

Those with the condition have blood glucose levels higher than they should be but are not yet high enough to be classified as diabetes. The higher levels put them at greater risk of developing not only diabetes, but also stroke and heart disease.

While pre-diabetes has been around for years under a different moniker, a growing body of research uncovering its considerable threat encouraged health officials to push for greater awareness and recognition.

"If you tell people that they don't have diabetes yet, they think 'Oh good.' They take that loophole," says Anne Daly, past-president of health care and education for the American Diabetes Association, based in Alexandria, Va. "We don't want people to take that loophole."

Who Is at Risk?

The good news is that with quick intervention a future full of insulin shots can be avoided. Among those at the greatest risk of developing pre-diabetes, and full-blown diabetes, include:

• Those with a family history of diabetes, as well as those who have had high blood sugar while pregnant — a condition known as gestational diabetes.
• Those who belong to minority groups that are disproportionately affected by diabetes, including African Americans, Native Americans, Latinos and Pacific Islanders.
• Those who are overweight or obese.
• Those with high blood pressure or blood fats.
• Those who are sedentary or inactive.

To ward off the the disease, health officials recommended specifically that overweight people over the age of 45 be screened for pre-diabetes.

Keeping Diabetes at Bay

A major message of the government-backed campaign, however, is that diabetes need not be an inevitable conclusion after a pre-diabetes diagnosis.

"Progression to type 2 diabetes can be prevented by lifestyle modification," says Dr. Joann E. Manson, chief of the division of preventive medicine at Brigham and Women's Hospital in Boston, Mass. "Most importantly, lose weight and become physically active."

Medications, such as metformin, may be used in some instances to lower blood sugar. But some experts emphasize the importance of diet and exercise over medical intervention.

"We know that losing weight is effective," says Daly. "In order to create a calorie deficit, which is how you lose weight, you've got to decrease what's coming in the door and increase what's going out the door. You need to work on both sides of that energy equation. You can try to be a couch potato and eat like a bird, but it isn't going to work."

For those who are baffled about getting started on an effective diet and exercise program, Daly recommends consulting a dietitian or other health-care professional for help.

Adds Daly, "If we identify more people with pre-diabetes, it is likely we can prevent heart attacks and strokes by the bucket full, by implementing lifestyle change to decrease medical risk factors that are an accident looking for an place to happen."

Click here for a link to the original article.

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Great Lakes Clinical Trials is currently seeking volunteers with type 2 diabetes, pre-diabetes and other complications related to diabetes such as diabetic neuropathy and fatty liver disease, to participate in our research studies.  Our research is led by board-certified physicians and registered dieticians and is provided at no cost to you. 

For more information you can visit our study information pages here or simply complete the fields below and one of our research staff will be in touch with you shortly. 

Managing the Holidays With Diabetes

For people with diabetes or even pre-diabetes, holiday parties present challenges. There’s a great deal of temptation to sway from a diet and eat large holiday meals, sample sugary desserts, and to increase alcohol consumption over the holiday season.  How can you manage the temptation without risking your health? 

The American Association of Diabetes Educators provide useful tips for patients in managing their condition.  Clinic on the image to the right to access the AADE Holiday Toolkit -- an informational resource that provides not only tips on how to manage the holiday temptations, but also how to prepare diabetic friendly meals. 

As the Toolkit say, "If you follow these strategies, you can maintain your blood sugar levels and enjoy the parties and gatherings along with everyone else. But, just like everything else with diabetes, you have to take a few extra steps!

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Great Lakes Clinical Trials is currently seeking volunteers with type 2 diabetes, pre-diabetes and other complications related to diabetes such as diabetic neuropathy and fatty liver disease, to participate in our research studies.  Our research is led by board-certified physicians and registered dieticians and is provided at no cost to you. 

For more information you can visit our study information pages here or simply complete the fields below and one of our research staff will be in touch with you shortly. 

NOW ENROLLING! Breakfast Egg Research Study for Patients with Pre-Diabetes

Great Lakes Clinical Trials is looking for male and female volunteers for a research study involving the daily consumption of eggs (12 per week) at breakfast compared to non-egg breakfast foods. 

What is the objective of the study?
The purpose of this study is to evaluate the effects of eating eggs on metabolic health in people with increased risk of developing type 2 diabetes. 

What is my time commitment to the study?
You will be asked to visit our clinic on 7 occasions over approximately 3-4 months.  The study visits will last between 30 and 180 minutes.

Is there a study stipend?
There is no cost for participation in this study.  All study breakfast foods, tests and procedures are free of charge and we do not bill insurance.  For your participation, you will receive up to $575. 

You may be able to participate if you are:

1.     between 18-74 years old

2.     currently diagnosed as having pre-diabetes or if you are at risk for developing type 2 diabetes, as indicated by having at least 3 of the following 5 conditions:

• overweight
• elevated triglycerides
• low HDL-C (high-density lipoprotein-cholesterol)
• high blood pressure (or are on a blood pressure lowering medication)
• elevated glucose

3.     willing to consume study-related breakfast foods 6 days per week during two 4-week test periods

Note that other entry criteria will apply and can be discussed with our study staff.  Lab values, blood pressure and weight measurements will be verified at your first clinic visit.

If you are interested in joining this trial, please call our center directly at (773) 275-3500 to speak with one of our staff today or visit www.greatlakesclinicaltrials.com/eggstudy

Steve Satek to Provide Opening Address at 2017 AWARE for ALL - Chicago

Given the vital importance of clinical research in advancing understanding of the causes and cure for Alzheimer's Disease, mental health disorders, pain disorders and general health, Great Lakes Clinical Trials is excited to have a presence at AWARE for All: Chicago - Clinical Research Education Day.

Steve Satek, President of Great Lakes Clinical Trials

Steve Satek, President of Great Lakes Clinical Trials, is proud to provide the Opening Address at this importnat conference. "After participating in past AWARE for All events as a research panelist, I am humbled to have the opportunity to address this program from a more global perspective," commented Mr. Satek.  "The goal of AWARE for All and its organizer CISCRP, falls very much in line with that of Great Lakes Clinical Trials.  We all understand the important role volunteers play in clinical research and this program supports our mission of educating and informing the public about clinical research participation." 

Clinical trials have long been a source of groundbreaking treatment developments, assistance for patients and a small source of additional income for many. AWARE for All is an educational session outlining the process, benefits and options for participation in a variety of clinical trials. The event has free health screenings, as well as information booths from local healthcare professionals and community organizations. Connect with local doctors and patients to learn how you can engage with clinical trials locally. The event begins at 5:00PM, with discussions starting at 6:00PM. There will be free dinner served, as well as giveaways. This event is free to attend however pre-event registration is encouraged.

Presented by: Center for Information and Study on Clinical Research (CISCRP)

Tickets: Free, registration encouraged.
Location: The University of Illinois Chicago Forum, 725 W Roosevelt Rd, Chicago, IL 60608

Date & Time: Thursday, October 26 from 5:00PM – 8:00PM

AWARE for All: Chicago will take place on Thursday, October 26 from 5:00PM – 8:00PM at the The University of Illinois Chicago Forum. For more information:

Visit:  www.awareforall.org

Call: 877-633-4376

Email:  awareforall@ciscrp.org

Living with Diabetic Nerve Pain?

If you have Type 2 Diabetes and are experiencing nerve pain in your feet and/or legs, you may be able to participate in a clinical trial.

An investigational drug is being studied for patients who have diabetic nerve pain (also called painful diabetic peripheral neuropathy or pain associated with diabetic peripheral neuropathy). The purpose of this study is to evaluate if the investigational drug works and determine its safety.

You may be able to participate if you:

• Have pain associated with diabetic peripheral neuropathy in your feet and/or legs
• Are 18-70 years of age
• Have type 2 diabetes

The study team will also review other criteria with you to determine your full eligibility.  You will receive all study-related care and study-related drug at no cost.

This trial will involve 5 visits to our clinic over 6 to 9 weeks consisting of these steps:

• Screening Period (1 clinic visit):  1 to 4 weeks
• Maintenance Period (3 clinic visits):  4 weeks during which you will need to swallow 2 capsules once daily
• Follow-up Period (1 clinic visit):  1 week after the last dose for assessment of side effects and lab tests.

If you are interested in joining this trial, please call our center directly at (773) 275-3500 to speak with one of our staff today or visit www.greatlakesclinicaltrials.com

Great Lakes Clinical Trials Participated in the Arlington Heights Senior Services Expo

Great Lakes Clinical Trials' President, Steve Satek with his mother, Pat Satek

Great Lakes Clinical Trials was proud to meet hundreds of seniors at the 2017 Senior Service Expo located at the state-of-the-art Arlington Heights Senior Center.  GLCT President, Steve Satek, discussed the various memory research studies ongoing at Great Lakes with a special emphasis on the studies that have started at their new location within the Lutheran Home (800 West Oakton in Arlington Heights).      

"I couldn't be happier to discuss the exciting research we are conducting at our Arlington Heights facility," commented Steve. "We partnered with the Lutheran Home to provide direct access to cutting edge research studies for both the residents of the Lutheran Home and Luther Village, as well as for all residents of the surrounding Northwest Suburban communities."

Great Lakes Clinical Trials' research programs in Arlington Heights are for seniors who are generally healthy and are not experiencing significant memory loss.  "We are studying new treatments to help prevent future memory loss," added Steve.  "Now is the time for today's seniors to participate in research and be part of the solution to ending Alzheimer's disease - before the memories are lost."

All research at Great Lakes Clinical Trials is provided free-of-charge, and insurance is not required. Research is conducted by board-certified clinicians.  For more information on the research programs and to learn how to participate, call (773) 275-3500 or click here for more information. 

Great Lakes Clinical Trials Contributes to Successful Rheumatoid Arthritis Study

Great Lakes Clinical Trials, under the direction of our board-certified rheumatologist, Dr. Manish Jain, has contributed to the successful results of our phase 3 Rheumatoid Arthritis clinical trial program.  

"I am proud of our team's work on this program," commented Steve Satek, President of Great Lakes Clinical Trials. "The true heroes of this program are our patients who participated in this program in spite of the uncertainty of risk or benefit.  Without these individuals who volunteered their time and committed to the program, there would be no advancement in medicines, no cures and no promise of a better tomorrow." 

Highlights of the press release related to the program is provided below.  Please click here to download a PDF of the full press release.

PRESS RELEASE

AbbVie’s Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis

SELECT-BEYOND, the second study in the robust SELECT program, demonstrated positive results with both doses (15 mg and 30 mg once-daily) meeting the primary endpoints in a difficult-to-treat patient population, over half of whom had previously been treated with two or more biologics

• Both doses achieved low disease activity in over 40 percent of patients at week 12 and over 50 percent of patients at week 24
• The safety profile of upadacitinib was consistent with previously reported studies, with no new safety signals detected
• Upadacitinib, an oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in rheumatoid arthritis in the SELECT program and across multiple immune-mediated diseases

NORTH CHICAGO, Ill., Sept. 11, 2017 – AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-BEYOND clinical trial evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond or were intolerant to treatment with biologic DMARDs (bDMARDs).  Results showed that after 12 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study’s primary endpoints of ACR20 and low disease activity (LDA). All ranked secondary endpoints were also achieved with both doses. Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established. 

“We are very pleased with the positive results for upadacitinib in the SELECT-BEYOND trial. Particularly exciting is the proportion of patients who achieved clinical remission by week 12 and 24, despite having inadequate responses with previous biologic therapies,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “Together with previously reported results from SELECT-NEXT, these data further support the potential for upadacitinib to be a meaningful treatment option for rheumatoid arthritis patients. We continue to build upon our leadership in immunology as we advance the development program for upadacitinib across a broad range of immune-mediated diseases.” 

About the SELECT Study Program

The robust SELECT Phase 3 RA program evaluates more than 4,000 patients with moderate to severe rheumatoid arthritis in six studies. The studies include assessments of efficacy, safety and tolerability across multiple rheumatoid arthritis patient populations. Key measures of efficacy evaluated include ACR responses, disease activity and inhibition of radiographic progression. More information on this trial can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426). 

About Upadacitinib

Discovered and developed by AbbVie, upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of rheumatoid arthritis and other immune-mediated inflammatory disorders. Phase 3 trials of upadacitinib in psoriatic arthritis are ongoing and it is also being investigated to treat Crohn’s disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.

Upadacitinib is an investigational oral agent and is not approved by regulatory authorities. Safety and efficacy have not been established. 

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn. 

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2016 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

References related to the above information can be found in the full press release by clicking here

Great Lakes Clinical Trials Memory Experts Invited to Present at Alzheimer's Association Research Symposium

Great Lakes Clinical Trials is honored to have two of their memory research experts, invited to speak at the 2017 Alzheimer's Association Research Symposium, hosted by the Illinois Chapter.  Dr. Linda Rice, Board-Certified Clinical Neuropsychologist will be joined by Great Lakes Clinical Trials President, Steve Satek, to present at the educational sessions on the topic of "The Genetics of Alzheimer’s Disease. 

Steve Satek

Linda Rice, PhD

"Many people with Alzheimer’s Disease are concerned that they have inherited the condition and may in turn pass it on," commented Mr. Satek.  "Our presentation and discussion outlines the present state of knowledge about the genetics of Alzheimer’s Disease. Genetic risk factors will be described and explained."   Attendees will also learn what researchers know about genetics, age, chromosomes and family history and how these factors are incorporated into the design of Alzheimer’s Disease clinical trials, including the new National GeneMatch research registry.

The theme of this year's symposium is "Educate. Ignite. Integrate."  National, regional and local dementia researchers and experts will present the latest and emerging dementia-related research topics including innovative care practices, technology based care and treatment options, theories and discoveries with a special focus on translating research into care.

WHERE IS IT?
This year’s Symposium is being held at the Swissôtel Chicago, with stunning views of Lake Michigan and the Chicago Skyline, the Swissôtel offers an exclusive destination setting for our full-day Symposium and expo.  The street address of the venue is 323 E Upper Wacker Dr, Chicago, IL 60601.

WHEN IS IT?
November 2, 2017 | 7:30 a.m. - 3:30 p.m.

WHO SHOULD ATTEND?
Physicians, researchers, health care professionals, professional caregivers, students and members of our community looking to enhance skill sets and gain insights on Alzheimer’s and dementia-related topics. CME and CEUs offered. 

REGISTRATION
To register for this event, click HERE to be taken to the Alzheimer's Association website.

ABOUT GREAT LAKES CLINICAL TRIALS
Great Lakes Clinical Trials is an independent, phase I-IV clinical trials center that specializes in the study of new medications for the prevention, treatment and cure of memory disorders such as Alzheimer's Disease.  With two Chicago area locations in the Andersonville neighborhood of Chicago and in Arlington Heights, the Great Lakes team have managed more than 450 clinical trials over the past 25 years and are committed to providing quality services for both study volunteers, their caregivers & the research industry. All medical services at  Great Lakes Clinical Trials are provided free-of-charge (no insurance required).  Health information is kept confidential, unless collaboration with your personal physician is requested.  A stipend will provided for your participation - amounts vary based on each study.  Free transportation is also provided for some trials.  For more information, call (773) 275-3500.