Celebrating a Milestone in Alzheimer's Treatment

Profound Research extends our heartfelt congratulations to our sponsor partner, Eli Lilly, on the recent approval of Kinsunla™ by the Food and Drug Administration (FDA). This groundbreaking development marks a significant step forward in the battle against Alzheimer's disease, providing new hope to individuals and their families affected by this debilitating condition. 

To learn more about Kinsunla™, read the full release at Eli Lilly. 

Kinsunla™, now the second drug on the U.S. market aimed at slowing the progression of early-stage Alzheimer's, has demonstrated remarkable efficacy. According to Eli Lilly, the drug slowed cognitive and functional decline by up to 35% compared to placebo at 18 months in its pivotal Phase 3 study. Furthermore, it reduced participants' risk of progressing to the next clinical stage of the disease by up to 39%. These promising results underscore the potential of Kinsunla™ to transform the landscape of Alzheimer's treatment. 

Profound Research at Neurology Center of Southern California (NCSC), under the leadership of Principal Investigator, Benjamin Frishberg, MD, is proud to serve as a site for the TRAILBLAZER program. Dr. Gregory Sahagian, CEO of NCSC and Chief Scientific Officer for Profound Research, emphasized the significance of this achievement, stating, "This is why we do clinical research. This is an advancement over previously approved therapies and a step forward in our fight to overcome Alzheimer’s Disease. Our patients have been enrolled in the study and were provided the opportunity for early access to a disease modifying therapy." 

April Tenorio, CCRC, Clinical Research Site Manager for Profound Research at NCSC, sharing her appreciation, stating: "As Kisunla™ steps into the market, the lasting impact of our site stands strong, showcasing the importance of teamwork, determination, and advancements in science. It serves as a reminder that behind every clinical research setting, there exists the opportunity to make a difference in people’s lives and shape the course of medical advancements. It has been a remarkable journey that we are all proud to be a part of!" 

This most recent achievement aligns with Profound Research's mission of contributing to continued innovation in medicine while improving health outcomes. Our involvement in the development and approval of Kinsunla™ highlights our commitment to progress and our dedication to supporting advancements that enhance the quality of life for patients.  

Once again, we commend Eli Lilly on this momentous development. With this promising new treatment, clinical research is paving the way for a brighter future for patients with Alzheimer's, bringing hope and potential benefits to those affected by this challenging disease.

At Profound Research, we are dedicated to delivering clinical trials and advanced therapies to diverse communities across the nation. Today, we are thrilled to feature insights from Susana Wallace, a Patient Recruitment Specialist in Southern California. As a Native American and lifelong San Diegan, Susana’s passion, dedication, and alignment with our core values play a crucial role in connecting cutting-edge medical advancements with the communities that need them most, making her an invaluable asset to our team. 

What is your role at Profound research and how long have you been doing it? 

For the better part of the last year, I have served as a Patient Recruitment Specialist at Profound Research for the Neurology Center of Southern California (NCSC), Dermatology Medical Group of North County (DMG) and Arthritis Consultants of North County (ACNC).  

Before coming to Profound, I was a research coordinator for University of Southern California at San Diego (UCSD) School of Medicine. I have also worked for the County of San Diego Public Health Department, as well as the California Department of Public Health (CDPH), doing surveillance, epidemiology, and communicable disease investigations. 

Please tell us a little about you personally. 

Born and raised, I am a Native San Diegan- I grew up in Valley Center, spending time between La Jolla Indian Reservation and Rincon Indian Reservation. I am married (19 years) and have two kids. We spend a lot of time outdoors hiking and going to the beach. I personally love running, gardening, and spending time with my family. 

What is your favorite part of your role at Profound Research? 

My favorite part of my role is connecting with the patients; listening to their stories and finding out what brings them to Profound. Most of all, getting them scheduled for a visit for one of our clinical studies is extremely rewarding. 

What is one thing all people should know about clinical research with Profound Research?  

People should know that when they choose to come to Profound, they will be well taken care of. 

Of our values - Compassion, Efficiency, Progress, and Integrity, what is one that resonates with you in your current role and tell us a time it applied to an interaction with a patient or co-worker? 

While compassion comes to mind, I still would have to say it is integrity. Integrity strongly resonates with me. Coming from a culture that is deeply affected by our healthcare system, public health programs, and past research practices, my community is suspicious. Integrity is a personal responsibility and obligation I have to all our patients, and especially those who may not have access to appropriate care. Some examples would be patients under-represented in research, uninsured and unable to access care, and under- served populations that do not know how to navigate the healthcare system. Although integrity comes in all forms, for me, it comes in the way we offer and extend services to patients. I want to do all I can to remove any fears or suspicions they may have. 

From working in academia and government, I have learned one thing - when doing research, it is so important to have a diverse team. Patients want to see someone that looks like them, can relate to them and most importantly, understand them. Profound Research offers that to the communities we are currently trying to reach and that is a form of INTEGRITY. Having a research team that looks like the population they are serving is so special. 

I am so fortunate to have found a space at Profound Research where I am at peace with the work I am doing. 

To learn more about clinical trials at Profound Research by click here.

At Profound Research, we're committed to highlighting the individuals who are advancing medical science and patient care through their work in clinical research. Today, we're excited to share insights from Dr. Barry Feldman, an Internal Medicine provider, and Principal Investigator at Profound Research. Dr. Feldman practices at Michigan Healthcare Professionals (MHP) TriAtria, a multidisciplinary health practice and research site in Farmington Hills, MI. MHP TriAtria, which encompasses a broad spectrum of medical indications including neurology, endocrinology, cardiovascular, and internal medicine, attends to approximately 36,000 annual patient visits. Join us as we explore Dr. Feldman's journey in clinical research, gaining valuable insights into his experiences and contributions to the field.  

What led you to clinical research? 

Dr. Feldman: My first endeavor into clinical research was at Northwestern University. I was working nights as a young graduate student and going to school during the day. I was working in the automated chemistry lab, supervising the night shift. We were running samples from the ongoing Framingham Cholesterol Study. Although the study began in 1948, we were still following participants in the early 1970’s. We had developed better testing abilities and computer technology. This study went on to change the way we looked at lipids and heart disease.   

While there, I was recruited onto the Renal Transplant team, working in organ harvesting and preservation. This was an exciting and relatively new field with new and ongoing research. Tissue typing was in its early stages and far from perfect. HLA typing was standard practice.  Northwestern had begun working on Mixed Lymphocyte Culture research as a confirmatory methodology. I became involved in the bench and clinical research - following organs from donor to recipient and witnessed firsthand how this changed lives. This experience was both exciting and incredibly rewarding. 

2. What is your favorite part about working in clinical research? 

Dr. Feldman: It’s all about the process - following the research process from being presented with a problem, to the concept of a possible solution, the challenge of proving it, and the real-life implementation. This was never more evident than in the past 3 years. During the COVID pandemic we worked at warp speed, developing testing, immunization, and therapeutic processes, that did not exist previously. 

3. Do you have a particular success story that stuck with you? 

Dr. Feldman: My favorite research period has been the past three years. On March 22,2020, like all the medical community, we went to war against COVID. I felt that I had to do something. With the help of my wife Lesley, and a small, dedicated crew, I put up a tent and trailer in the parking lot behind my medical building. Over the next two years, we went on to test over 160,000 lives and deliver 18,000 vaccines. We also treated those patients who were sick, keeping 16,000 out of ER’s and hospitals. We worked with research partners on Monoclonal Antibody infusion, for which I was one of the PI’s.  This was an example of experiencing research in hyperdrive. 

4. What would you want people to know about clinical research? 

Dr. Feldman: Clinical research has and continues to make lives better and longer. When I was a medical student, the life expectancy of a man was 60 years. Today, it’s 78 years. In my lifetime, I have been blessed to see multiple infectious diseases controlled, devices and procedures that sustain, improve, and prolong life, as well as drugs that enable better quality and duration of life. All of this is the result of dedicated individuals doing research with the imagination to develop new paradigms. 

5. What are some hobbies/interests of yours outside of clinical research? 

Dr. Feldman: In addition to my dedication to clinical research, I’m an avid golfer and find solace and joy in time spent with my family. 

Beyond personal pursuits, my passion for teaching extends to shaping the minds of future physicians. As an educator, I am privileged to impart knowledge, instill values, and inspire the next generation of healthcare professionals. Witnessing their growth and seeing the spark of curiosity ignite within them is immensely rewarding, reaffirming my commitment to perpetuating excellence in medical practice and research. 

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In Closing 

As we conclude this spotlight on Dr. Feldman, we are reminded of the profound impact that passionate individuals can have on our collective well-being. We encourage you to stay engaged with Profound Research as we continue to spotlight those who shape the future of science and healthcare. We eagerly anticipate sharing more visionary leaders in our upcoming editions of the Profound Research Spotlight Series. 

Skin Biopsy as a Potential Diagnostic Tool for Synucleinopathies Exploring Promising Avenues in Neurological Research

The groundwork for a notable advancement in establishing new diagnostic procedures for Synucleinopathies through skin biopsy has been laid by a recent collaboration of 28 research organizations across the United States. Among the participants in this study was The Neurology Center of Southern California, a respected member of the Profound Research site network. 

Central to this study is a fundamental question: Can phosphorylated α-synuclein be detected in individuals with synucleinopathies such as Parkinson's disease (PD), multiple system atrophy (MSA), dementia with Lewy bodies (DLB), and pure autonomic failure (PAF) through skin biopsy? The findings, revealed through a thorough cross-sectional analysis of 428 participants, are indeed promising. 

According to the study, a significant proportion of individuals with PD, MSA, DLB, and PAF exhibited the presence of cutaneous phosphorylated α-synuclein, as detected by skin biopsy. The numbers were particularly notable: 92.7% for PD, 98.2% for MSA, 96.0% for DLB, and an impressive 100% for PAF. These findings shed light on a hopeful avenue for improving diagnostic accuracy in neurological disorders. 

Gregory Sahagian, CEO of the Neurology Center of Southern California and Chief Scientific Officer for Profound Research, shares his perspective on this groundbreaking endeavor, remarking, "The implications of these findings are profound. They offer hope for earlier and more accurate diagnoses and open doors to potential breakthroughs in treatment strategies." 

However, amidst the excitement stirred by these findings, it's crucial to proceed with caution. As with any scientific inquiry, further validation and exploration are necessary. While this study presents compelling evidence of the effectiveness of skin biopsy in detecting phosphorylated α-synuclein, there remains a pressing need for broader research in unselected clinical populations to confirm these findings and fully understand their clinical implications. 

In summary, the emergence of skin biopsy as a potential diagnostic tool for synucleinopathies represents a promising development in neurological research. As we navigate this evolving landscape, we remain steadfast in our pursuit of bringing about meaningful advancements in healthcare for the communities that stand to benefit the most. 

For a full review of the study and it’s participants, visit https://jamanetwork.com/journals/jama/article-abstract/2816441  

JAMA is a peer-reviewed medical journal published by the American Medical Association. 

At Profound Research, we're committed to highlighting the individuals who are advancing medical science and patient care through their work in clinical research. Today, we're excited to share insights from Paul Lizotte, an Internal Medicine provider and Principal Investigator at Profound Research. Dr. Lizotte practices at Seaside Medical Group (SMG) in Oceanside, CA. The clinic, which encompasses a broad spectrum of medical indications, including vaccine and internal medicine, consistently attends to approximately 75 patients every month with expanding access due to the recent addition of a new PA-C. Join us as we explore Dr. Lizotte's journey in clinical research, gaining valuable insights into his experiences and contributions to the field.  

What led you to clinical research? 

Dr. Lizotte: My journey into clinical research stemmed from my background in academic institutions. Throughout my career, I've found fulfillment in conducting trials and contributing to medical literature through published papers. The opportunity to actively engage in the advancement of medical knowledge has always been a driving force for me. 

In addition to my academic pursuits, I am deeply committed to bringing cutting-edge therapies to my patients. Clinical research allows me to bridge the gap between medical innovation and patient care, which is incredibly rewarding. 

2. What is your favorite part about working in clinical research? 

Dr. Lizotte: My favorite aspect of clinical research is undoubtedly the opportunity to bring new therapies to patients who may not otherwise have access to them. Witnessing the tangible impact of these treatments on individuals' lives is profoundly gratifying. Knowing that I have played a part in improving patient outcomes and quality of life is what fuels my passion for this work. 

Moreover, collaborating with fellow researchers and healthcare professionals in the pursuit of medical advancement is both intellectually stimulating and fulfilling on a personal level. 

3. Do you have a particular success story that stuck with you? 

Dr. Lizotte: One success story that remains etched in my memory involves my involvement in a trial for an oncology medication called Bexar. This medication proved to be a game-changer for many patients battling cancer, offering them newfound hope and improved prognoses. 

Witnessing the transformative impact of Bexar on patients' lives was truly remarkable. Seeing individuals regain their vitality reaffirmed my dedication to clinical research and its potential to make a meaningful difference in healthcare. 

4. What would you want people to know about clinical research? 

Dr. Lizotte: One misconception that I often encounter is the belief that clinical research is fraught with deceit or serves as a platform for promoting dubious treatments. However, as a healthcare provider and researcher, I can attest to the rigor and integrity that underpins reputable clinical trials. 

It's crucial for people to understand that clinical research is conducted with the utmost ethical standards and patient safety as top priorities. As a physician, I am committed to transparency and honesty in my practice, and I would never endorse a treatment that I believe to be harmful or ineffective. 

Ultimately, clinical research serves as a vital conduit for bringing forth medical advancements that have the potential to positively impact countless lives. By participating in clinical trials, patients not only contribute to the advancement of science but also gain access to innovative treatments that may offer hope where conventional therapies fall short. 

5. What are some hobbies/interests of yours outside of clinical research? 

Dr. Lizotte: Outside of my professional endeavors, I am an avid enthusiast of archaeology, particularly ancient civilizations. I've had the privilege of participating in archaeological digs in Italy and Switzerland, where I've immersed myself in the exploration of Etruscan tombs. 

Unearthing precious artifacts and unraveling the mysteries of ancient cultures has been a deeply enriching experience for me. It serves as a welcome respite from the rigors of clinical research and allows me to indulge in my passion for history and discovery. 

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In Closing 

As we conclude this spotlight on Dr. Lizotte, we are reminded of the profound impact that passionate individuals can have on our collective well-being. We encourage you to stay engaged with Profound Research as we continue to spotlight those who shape the future of science and healthcare. We eagerly anticipate sharing more visionary leaders in our upcoming editions of the Profound Research Spotlight Series.