Great Lakes Clinical Trials' Generation Study Highlighted in Wall Street Journal

The following article on the Generations study and Genematch program was published in The Wall Street Journal on April 22, 2017.


NOVARTIS TESTS NEW ALZHEIMER’S DRUG ON PEOPLE WHO DON’T HAVE THE DISEASE

The hope is that early treatment to prevent Alzheimer’s from taking hold will prove more successful than efforts to halt the disease’s progress.

By Denise Roland

April 22, 2017

 

Novartis AG  thinks its best bet for testing two new Alzheimer’s drugs is on people who don’t actually have Alzheimer’s.

The Swiss drug giant is looking for people whose genes put them at high risk of developing Alzheimer’s, but who haven’t yet fallen victim to the mind-robbing disease. It hopes such early treatment proves more successful than past efforts to tackle the disease once it has taken hold.

The history of Alzheimer’s research is marked by disappointment. In November, a high-profile Eli Lilly LLY 1.87% & Co. drug called solanezumab was the latest to fail a late-stage clinical trial. That drug aimed to clear clumps of a protein called beta amyloid in the brain, which are closely linked with Alzheimer’s. So far, no company has produced a drug that can delay the progression of Alzheimer’s.

One of the new Novartis drugs, known as CAD106, is designed to boost the immune system’s ability to clear beta amyloid from the blood. The other, which Novartis is developing with Amgen Inc. and is called CNP520, aims to stop its formation in the first place.

“If an anti-amyloid strategy is going to work, the best way to do so is with prevention,” said Steven Arnold, a neurologist at Massachusetts General Hospital in Boston.

Recruiting patients to receive treatment for a disease they don’t have—and may never develop—is riven with logistical and ethical challenges.

The company is looking for people with two copies of a gene called APOE4 to participate in its study. Having two copies of the gene doesn’t inevitably lead to Alzheimer’s, but the roughly 2% of people who fit this profile are around three times as likely to develop dementia as the general population, according to a recent analysis in the scientific journal PLOS Medicine.

The Banner Alzheimer’s Institute, a Phoenix nonprofit, is helping Novartis find eligible participants with a campaign launched at the end of 2015 to test people for the APOE4 gene. The institute places television and newspaper ads, does mass mailings and runs events in clinics to publicize the program, called Genematch.

So far, around 35,000 people have signed up, agreeing to send swabs of their cheek cells for testing. “We seem to have tapped into a very motivated group of people,” said Pierre Tariot, director of Banner. “Not surprisingly, a lot of them have a family history of Alzheimer’s.”

Amyloid plaque deposition in a person with Alzheimer's dementia, left; a person who is cognitively unimpaired but at high risk for developing Alzheimer's symptoms, center, and an unimpaired person at low risk, right.

Margaret, a 71-year-old from Virginia, discovered two weeks ago that she has two copies of the APOE4 gene. She signed up for the Genematch program earlier this year after hearing about it through the hospital that is caring for her older sister, who has Alzheimer’s.

“It is shocking,” said Margaret, who declined to give her last name because she hasn’t yet told her family. But “if this works and can prevent or slow it down, then obviously I’d like to participate. That part of it is a no-brainer.”

Only a fraction those who sign up will be eligible for the trial. As well as having two copies of the APOE4 gene, participants in the Novartis study must be healthy, between the ages of 60 and 75, and have no outward signs of Alzheimer’s, such as cognitive decline. Fewer than 10% of the roughly 1,300 participants needed for the trial have been recruited so far, Dr. Tariot said.

The Genematch staff doesn’t know any individual participant’s genetic results. Instead, a computer program provides a list of names—only some of whom are genetic matches—for them to call. On that call, Genematch will tell the person they might be eligible for a trial and tell them about nearby participating hospitals.

Participants are informed of their genetic profile—usually by a genetic counselor—only after a lengthy assessment by staff at the clinical-trial site to determine that they are eligible for, and willing to enroll in, the study.

“The critical thing is that this is done in a highly ethical way,” said Vas Narasimhan, global head of drug development at Novartis. “If a patient is not selected for the study, we are not intervening to help them so there is no reason to provide them with this information.”

The Novartis study is among a small group of trials that might still vindicate the beta amyloid-targeting approach to Alzheimer’s drugs. Shown, a building on the Swiss pharmaceutical giant’s campus in Basel in 2015.

Later this year, Novartis plans to start a further trial that will be open to people who have just one copy of the APOE4 gene, Dr. Narasimhan said. Around a quarter of the population is thought to fit this profile, and they are about 1½ times as likely to develop mild cognitive impairment or dementia as the general population.

After the string of high-profile failures in amyloid-busting drugs, experts are divided over whether they are the right approach to tackling Alzheimer’s. “The field is very pessimistic right now,” said Murali Doraiswamy, director of the neurocognitive disorders program at Duke University Health System in Durham, N.C.

But the Novartis study was among a small group of trials that could still vindicate this approach, Dr. Doraiswamy said. “We’ve learned a lot from previous [failed] trials,” he said, adding that the “elegant” design of the Novartis study—in focusing on a narrow band of people known to have heightened risk of Alzheimer’s—makes it a “near-perfect model to test the amyloid thesis.”

Swedish Covenant Hospital Hosts A Free Family-Oriented Community Event

Please join Great Lakes Clinical Trials in supporting Swedish Covenant Hospital's upcoming Summer Social.  It's fun for everyone! Admission is FREE so bring the whole family to enjoy this rain or shine event:

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  • Free bike helmets (for the first 1,000 attendees) provided by Swedish Covenant Hospital
  • Live entertainment and DJ
  • Bouncy houses
  • Face painter and balloon artist
  • Helmet decorating and other kids activities
  • Summer safety giveaways and bike safety tips
  • Food trucks
  • Raffle prizes and more!

The event will be held in the parking lot of Galter LifeCenter at 5115 N. Francisco. FREE parking in Swedish Covenant Hospital’s garage (entrance at California & Winona). We will have a big bike rack and also a DIVVY station onsite.

More info:
SwedishCovenant.org/SummerSocial
 

Andersonville Businesses Donate $1,500 in Health Fair Raffle Prizes

Great Lakes Clinical Trials and the organizers of the 2017 Andersonville Health Fair would like to offer our sincere appreciation for the donations received from our community business for our raffle drawing.  All health fair visitors who stop by each of our vendor booths will be entered into drawings to win the following:

  • Platinum Package......Estimated Value $430
  • Gold Package......Estimated Value $275
  • Silver Package......Estimated Value $255
  • Bronze Package......Estimated Value $230
  • Taste of Andersonville......Estimated Value $135
  • A “Pizza” Andersonville......Estimated Value $90
  • Foot Care Gift Basket......Estimated Value $50

In total, we will be raffling off nearly $1,500 in prizes.

"I cannot be more proud to be resident and business owner in Andersonville," commented, Steve Satek, President of Great Lakes Clinical Trials and Chairman of the 2017 Andersonville Health Fair. "The amazing group of vendors we have exhibiting at the Health Fair and the quality & volume of raffle prizes from our local establishments is overwhelming!  Vendors are all donating their time and the raffle prize were also all donated, so that we could offer this Health Fair at no cost to the residents of our community." 

The event will take place at Great Lakes Clinical Trials, located at 5149 North Ashland in Chicago from 10:00-2:00pm on Saturday, April 22.  RSVP to (773) 275-3500.  No cost to participate. 

Great Lakes Clinical Trials Contributes to FDA Approval of First and Only Approved Treatment for Adults with Tardive Dyskinesia

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Great Lakes Clinical Trials is pleased to share the announcement from Neurocrine Biosciences related to the FDA Approval of INGREZZA TM (valbenazine) Capsules as the first and only FDA-approved treatment for adults with Tardive Dyskinesia (TD).

Tardive Dyskinesia is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face and is estimated to affect at least 500,000 people in the U.S. Up until this point, there was no available treatment for this debilitating disease.  

"Our team at Great Lakes Clinical Trials is committed to improving the quality of life for patients in our community and around the world,"  commented Steve Satek, President of Great Lakes Clinical Trials. "We are proud to have participated in the development program of valbenazine and give our most sincere thanks and appreciation to the volunteers who participated in this research program at our clinic.  Without clinical trial volunteers, important medications like this would never receive FDA approval and become available by prescription."

To view the full press release from Neurocrine Biosciences, please click here.

Steve Satek Presents A Lecture Entitled "Embracing the Future of Alzheimer's Disease"

Steve Satek, Co-Founder of Great Lakes Clinical Trials

Steve Satek, Co-Founder of Great Lakes Clinical Trials

As part of the free Alzheimer’s Research: Get Informed, Get Involved lecture series sponsored by the Alzheimer's Association Greater Illinois Chapter, Steve Satek, President and Co-Founder of Great Lakes Clinical Trials will be presenting a lecture entitled "Embracing the Future of Alzheimer's Disease". The event will take place on Thursday May 4, 2017 from 2:00-3:00 p.m

"I'm proud to be involved in this lecture series," commented Mr. Satek, who also serves on the Alzheimer's Association Greater Illinois Chapter Medical & Scientific Advisory Board. "These programs provide the opportunity to discuss current trends, efforts and directions in dementia research. We are making great strides in Alzheimer's research and these presentation are a means to get the word out to those who want to make a difference in finding a prevention or cure." 

This dynamic presentation will provide the latest updates on Alzheimer's research and discuss the impact of clinical trials on the future of treatments. Join us to learn about the latest updates on Alzheimer's research, including:

• Current efforts to fight Alzheimer's disease in your community
• The role research plays in developing the next generation of treatments
• Explore the benefits of being a study participant; Engage in TrialMatch®
 

The Alzheimer's Association will also be on site to provide an overview of services and each participant will receive access to the Alzheimer's Association's TrialMatch® registry.

The event will be hosted by Loyola Gottlieb Memorial Hospital, Professional Office Building Room E, F & G, located at 701 W. North Ave in Melrose Park, IL.   Registration is required for this FREE series - to RSVP, call 847.324.0393 or email hjohnson@alz.org

To download a copy of the event flyer click HERE

 

Medical Food Research Study for Memory Lapses

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Have you or a loved one been experiencing noticeable memory lapses?  If so, this could be a condition known as Mild Cognitive Impairment.  About 50% of the population aged 65 years or older suffers from early memory impairment. Early memory impairment disrupts the day-to-day lives of many adults and may include symptoms such as: forgetting the “right word” and names/faces of individuals or difficulties in problem solving and handling complex situations.

Great Lakes Clinical Trials is conducting a study to evaluate a prescription medical food for patients with Mild Cognitive Impairment. To qualify, you must:

·      be between the ages of 65 and 85

·      be experiencing noticeable memory lapses, known as mild cognitive impairment

·      not be taking medication or over-the-counter supplements for memory loss

·      be otherwise, generally healthy 

The study lasts approximately 2 years and you will be asked to visit the clinic on 7 occasions.  The visits last between 1-3 hours in length.  If you qualify, you will receive study medications, exams and study related care at no cost.  In addition, qualified participants may receive reimbursement of up to $1,175.00 for time and travel.

To learn more about our current program, please call our patient care representatives at (773) 275-3500.  In addition, you can complete the form HERE and one of our team members will be in touch within the next business day.

Great Lakes Clinical Trials Supports AARP Foundation's Experience Corps Program

Great Lakes Clinical Trials is proud to collaborate closely with The AARP Foundation's Experience Corps. This important groups identifies and provides volunteers, ages 50 and older, to help children in kindergarten through 3rd grade learn to read.  The AARP Foundation provides peer support, mentoring, coaching and ongoing training to help older adults be successful. 

The AARP Foundation will be interviewing volunteers weekly at our Great Lakes Clinical Trials clinic, with hopes to connect older adults to volunteering opportunities within our neighborhood schools.

"This is an amazing program that we support 100%,"  commented Steve Satek, President of Great Lakes Clinical Trials.  We are passionate about keeping older adults active and helping them contribute to a thriving neighborhood community."

For more information on how to join the AARP Foundation's Experience Corps, you can call (312) 660-8655 or visit their website at www.aarpfoundation.org/ecchicago.

Great Lakes Clinical Trials Participates in Alderman Osterman's 48th Ward Senior Fair

Representatives of Alderman Osterman pass out Great Lakes Clinical Trials canvas grocery bags

Representatives of Alderman Osterman pass out Great Lakes Clinical Trials canvas grocery bags

Great Lakes Clinical Trials was honored to meet with hundreds of local residents at Alderman Osterman's 48th Ward Senior Fair. This year, Great Lakes Clinical Trials was a key sponsor of the event and provided free canvas grocery bags for all who attended.

"This is one our favorite events each year, when we get to personally meet with the local residents of our community and discuss how local seniors can participate in cutting-edge research studies, particularly in the area of memory loss," commented Dean Hervochon, Co-Founder of Great Lakes Clinical Trials. "When older adults learn about the important work we are doing, they are eager to join a research study and be part of the solution to ending Alzheimer's disease altogether.  Our biggest hurdle is simply getting the word out about our research. Once the folks learn about our work, then come knocking at our doors in mass!"

Great Lakes Clinical Trials is looking for participants for a variety of memory-related studies at our clinic on the corner of Foster and Ashland in Chicago.  Many seniors would be eligible to participate in these programs, regardless if they are experiencing memory loss or not. 

Clayton Terrill, Patient Care Coordinator at Great Lakes Clinical Trials

Clayton Terrill, Patient Care Coordinator at Great Lakes Clinical Trials

  • Our Alzheimer's Prevention studies are looking for older adults who are not currently experiencing memory problems, but may be at greater risk for developing the disease.  
  • Our Mild Cognitive Impairment studies are looking for participants who are just starting to experience a decline in memory that is affecting their daily activities
  • Our Alzheimer's Disease trials are recruiting subjects who have been diagnosed with the disease and are currently taking a memory medication such as Aricept (donepezil) or Namenda.

"All our studies and the related medical care are provided 100% free-of-charge," added Hervochon. "We provide transportation to and from our clinic for participants, and also provide a stipend at each visit. We try to eliminate as many obstacles as possible to encourage our neighbors to participate in this important work." 

If you are interested in learning more about our research, you can all our Patient Care Representatives at (773) 275-3500 or click HERE to fill out a contact form and one of our staff will reach out to you.

 

Familial Hypercholesterolemia: What Exactly Is This?

Familial Hypercholesterolemia

Familial Hypercholesterolemia (or FH) is an inherited disorder that leads to aggressive and premature cardiovascular disease. This includes problems like heart attacks, strokes, and even narrowing of our heart valves. For individuals with FH, although diet and lifestyle are important, they are not the cause of high LDL. In FH patients, genetic mutations make the liver incapable of metabolizing (or removing) excess LDL. The result is very high LDL levels which can lead to premature cardiovascular disease.

For more information, visit the FH Foundation Website by clicking on the image above

For more information, visit the FH Foundation Website by clicking on the image above

FH facts

About 1 in 250 people worldwide have FH.

In the United States alone, an estimated 1.3 million people live with FH. Yet only 10% of them are diagnosed. Can you imagine? Nearly 2 million people in the US might have FH and not even know it. Perhaps they won’t know it until they have a heart attack! This is what we want to change!

  • Over 90% of people with FH have not been properly diagnosed.
  • FH runs in families. If one parent has FH, each child has a 50% chance of having FH.
  • 1 in 250 people in the world have FH. 
  • An estimated 1.3 million people in the U.S. have FH.
  • If left untreated, men have a 50% rise of having a heart attack by age 50. Untreated women have a 30% risk by age 60.
  • 1 in 160,000 to 1 in 1 million people have HoFH.  
  • FH is even more common in certain populations such as French Canadians, Ashkenazi Jews, Lebanese, and South African Afrikaners. In these populations FH may be found as frequently as 1 in every 67 people.

What can I do?

FH is treatable!  If FH is found early, serious problems of the heart and blood vessels may be prevented or dramatically delayed by taking steps to protect yourself. These include:

  • Not smoking.
  • Exercising regularly.
  • Eating a healthy diet low in saturated and trans fats.
  • Taking medications.
  • Going on LDL-apheresis.

Nearly 100% of people with FH will require cholesterol-lowering medications. For some people with FH, more aggressive measures are needed. 

It is important to find FH and take action at any age, because when treated, the risk of heart disease can be reduced to levels similar to those of the general population.

Why participate in FH clinical research?

Clinical trials test new treatments or new combinations of treatments. Clinical trials help researchers evaluate the safety and effectiveness of therapies to improve the quality of care for affected individuals. 

By participating in clinical research, you will play an active role in your own healthcare and contribute to the greater good. Because FH is a family disorder, clinical research offers hope and the opportunity to have a powerful impact on the lives of your family members and your future generations.


If you are interested in being considered in FH research trials at Great Lakes Clinical Trials, please click HERE to fill out an interest form or call our patient care representatives at (773) 275-3500.

 

Great Lakes Clinical Trials to Host The Andersonville Health Fair!

Great Lakes Clinical Trials is honored to be hosting an Andersonville Health Fair on Saturday, April 22nd from 10:00am-2:00pm.  This free event is open to the public and will include a variety of complimentary services from local health care providers.  

In addition to free food, prizes and giveaways, the following Free Services will be provided at this health fair:

• Spinal Assessments
• Stroke Awareness
• Memory Assessments
• Blood Pressure Checks
• Physical Fitness Advice
• Chair Massages
• Skin Analysis
• Body Fat Measurements
• Body Composition Experts
• Foot Screenings
• Stretching and Posture Assessments

The event will also include the opportunity to participate in a bone marrow registration drive.  For those with blood cancers like leukemia, a bone marrow transplant is the only hope for life. A local resident and Swedish American Museum member has been diagnosed with mylodisplastic syndrome (or MDS). His blood count has been stable for the past 2 years, but at his last check up, they have begun to change. At this point his doctors are recommending starting the marrow transplant process as soon as possible. Unfortunately, his sister is not close enough “match” to be his donor.  This neighbor has now been placed on the national marrow list and is looking for an unrelated donor. Make this your time to step up and join the registry! 

Steve Satek, President of Great Lakes Clinical Trials is excited to be hosting the GeneMatch registry drive.  "This is a national program led by the Banner Alzheimer's Institute is used to recruit volunteers for Alzheimer’s prevention studies," commented Satek.  "We use genetic testing (through free cheek swab kits) to match volunteers with research opportunities. This program advances Alzheimer’s research by helping scientists find enough qualified participants to launch new studies. 80% of research studies don’t complete enrollment on time, because they can’t recruit enough volunteers. We hope to prevent those delays."

If you are interested in joining this Free Health Fair, please call (773) 275-3500 or reserve your space or click HERE to fill out our registration form.