TrialSite News seeks to foster and facilitate a much needed transparency of our coverage as well as our accessibility to readers. With clinical study abstracts and other study updates becoming harder and harder to not only understand but also find, we have made it our goal to change that. At our site, you can obtain to-the-point news that fits your busy schedule and helps you learn about the exciting and important industry of clinical trials.
TrialSite News was formed to contribute to the cause of making clinical research more accessible and transparent. Clinical trials, for example, can represent life-saving opportunities but far too few people are aware of this potential. With a growing number of advanced therapies in the clinical trials pipeline, it becomes imperative to breakdown and simplify information in such a way that more people can form a better understanding—and appreciation—for the incredible progress the research community is making. Few in the public, or even in the medical research community, have a medium to read about the daily progress and challenges faced by clinical research sites, their principal investigators and professional staff.
As part of our commitment to bring relevant and needed information to our readers, we are providing in-depth reviews of clinical investigational sites, becoming a valuable source for the many patients, doctors, investors, and institutions that regulatory visit. In this summary, we’ll summarize the Boston Center for Memory, their involvement in advancing the treatment of Alzheimer’s disease and the reputation of their staff and treatments. You may also read our summaries of McLean Hospital and Josephson, Wallack, Munshower Neurology, which are both involved in the same study as Boston Center for Memory.
About Boston Center for Memory
In 2012, a group of Alzheimer’s disease experts recognized the need for a full-time, multi-specialty clinical center dedicated to central nervous system-based research and treatment. Hence, the Boston Center for Memory (BCM) was launched to offer patients with mild cognitive impairment, Alzheimer’s disease, and related dementias, a timely and comprehensive evaluation, an accurate diagnosis, and a treatment plan tailored to each patient. Boston Center for Memory’s core mission is to provide: 1) education for patients, families/caregivers, and professionals 2) multi-specialty treatment utilizing a treatment team approach 3) follow up care to meet the patients and family/caregiver’s needs, and 4) research to provide better diagnostics for detection and better treatments for patients with Mild Cognitive Impairment, Alzheimer’s disease, and related dementias.
The quest for an Alzheimer’s treatment has been a long and arduous journey. And patients are desperate for treatments and with the aging Baby Boomer generation Alzhiemer’s cases will continue to rise. There was great disappointment when Bioten called off its aducanumab research program. However exciting news surfaced on October of this year when the Boston-area biotech company announced it would not only be resuscitating its Alzheimer’s program but also that it had secured larger sets of data from Phase III studies to support a New Drug Application (NDA) regulatory filing with the U.S. Food and Drug Administration (FDA)—truly exciting news. If aducanumab (BIIB037) was to be approved it could potentially make a huge difference in the lives of Alzheiemr’s patients and their loved ones.
One Biogen study, officially titled “221AD302 Phase 3 Study of Aducanumab (BIIB037) in Early Alzheimer’s Disease (EMERGE),” helped generate the data utilized for the planned submission. And Boston Center for Memory was a participating clinical investigative site. For the study.
Study Details and Participation
The primary start date was in September 2015 and was marked as complete in August of 2019. It was previously terminated but physicians and clinical trial leaders recently decided to continue research efforts.
The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI].
It has, as listed on ClinicalTrials.gov, 1638 participants and nearly 200 sites are listed in the trial.
Key Principal Investigator
The staff at the Boston Center for Memory have many years of impressive experience in their field, including Dr. Paul Solomon whom we believe to be their key principal investigator.
Dr. Paul Solomon is a founder and the Director of the Boston Center for Memory in Newton, MA. He specializes in Clinical Neuropsychology and Clinical Neuroscience. Dr. Solomon is also an Investigator of the Boston University Alzheimer’s Disease Center, Boston University School of Medicine.
Dr. Solomon was appointed Professor Emeritus of Psychology and Neuroscience at Williams College the summer of 2018. He was the founding Chairman of the Neuroscience Program at Williams College in Williamstown, MA. Dr. Solomon taught in the areas of neuropsychology and behavioral neuroscience and conducted research on the neurobiology of memory disorders.
He had a fully funded laboratory at Williams College for 20 years. He was particularly interested in the memory deficits associated with Alzheimer’s disease. During this time, he became interested in investigating memory disorders in a clinical setting and providing diagnostic and clinical care services to patients with neurodegenerative conditions.
Dr. Solomon and Dr. William Pendelbury (a neurologist at the University of Vermont Medical Center) founded the Memory Clinic (Clinical Neurosciences Research Associates) in Bennington, VT in 1987. Dr. Solomon served as the President and Clinical Director of the Memory Clinic from 1987-2017. He also served as the first Director of Training for the Memory Clinic as part of the Southwestern Vermont Psychology Consortium. He transitioned his time from the Memory Clinic in 2012 when he founded the Boston Center for Memory in Newton, MA.
As a lead investigator on the clinical trials for Cognex, Dr. Solomon contributed to the first drug approval for the treatment of Alzheimer’s disease in 1994. He was an author on the paper published in the Journal of the American Medical Association (JAMA) that served as the basis for the FDA approval of the drug. Since that time, he has served as a principal investigator on more than 150+ clinical trials in Alzheimer’s disease and served as an investigator on the trials that led to the FDA approval of the four approved medications available to treat Alzheimer’s disease (Aricept/donepezil, Galantamine/razadyne, Exelon/rivastigmine, Namenda/memantine). Additionally, he was an investigator of the trials that led to the approval of the first PET amyloid scan ligand (Amyvid/florbetapir).
The recipient of numerous awards, Dr. Solomon received a Distinguished Teaching Award from the University of Massachusetts, a National Research Service Award from the National Institutes of Health, and a National Needs Postdoctoral Fellowship from the National Science Foundation, and two clinical research awards from the American Association of Family Physicians. He has been elected as a Fellow of the American Association for the Advancement of Science, the American Psychological Association and the American Psychological Society. He is listed in Who’s Who in America, American Men and Women of Science, Who’s Who in Education, and Who’s Who in Frontier Science and Technology.
Dr. Solomon has served on the Editorial Board of several journals and serves as an external reviewer for numerous journals and granting agencies. He has served on the advisory boards of the Northeastern New York Alzheimer’s Association and the MA/NH Chapter Alzheimer’s Association. He has delivered more than 500 lectures nationally and internationally widely at colleges and universities on age-related memory disorders and at medical centers and hospitals on the diagnosis and treatment of Alzheimer’s disease.
Frequently appearing to discuss pharmacotherapy for Alzheimer’s disease on national television, Dr. Solomon has been seen on The Today Show, Good Morning America, The CBS Morning Show, and CBS, ABC, and NBC Evening News. His work on screening for Alzheimer ’s disease has been featured on Dateline NBC, NPR, Newsweek, New York Times, Forbes, and the Larry King Radio Show. Dr. Solomon developed two screening instruments for Alzheimer’s disease, the 7 Minute Screen, and the Alzheimer’s Disease Caregiver Questionnaire.
Dr. Solomon received his Ph.D. in Psychology from the University of Massachusetts Amherst. He was a postdoctoral fellow in the Laboratory of Richard F. Thompson in Department of Psychobiology at the University of California at Irvine. He is the author of 10 books, including most recently, Memory Loss, Alzheimer’s Disease, and Dementia, 2nd Edition, A Practical Guide for Clinicians. He has also contributed chapters to 20 edited volumes and has co-authored and presented more than 200 research papers. His work has been published in Science, Scientific American, Journal of the American Medical Association, and Lancet. He has delivered more than 500 invited colloquia, symposia, grand rounds, lectures, and presentations. He has been the recipient of research grants from the National Science Foundation, The National Institute on Aging, The National Institute of Mental Health, The United States Environmental Protection Agency, as well as private foundations and pharmaceutical research divisions. He is also a licensed clinical neuropsychologist in Massachusetts and Vermont.
TrialSite News researchers did not find any significant FDA Warning Letters or Inspections, suggesting strongly that they adhere to current regulations and standards. We have found their online presence to be full of positive reviews, and we invite you to explore their Facebook, LinkedIn and Google Listing. We did not find a Yelp page for their practice.
Call to Action: TrialSite News believes that accessible, relevant, and transparent clinical trial information should be provided without question. To learn more about future site reviews, we encourage you to sign up for our Daily Digest. You may also contact us if you have a clinical investigational site you would like us to cover.