You may ask yourself, “Why should I try something that researchers are not sure will work?” That is a good question. Being part of a clinical trial may have risks, but it may also have benefits.
Benefits of a Clinical Trial:
• You may get a new treatment for a disease before it is available to everyone.
• You play a more active role in your own health care.
• Researchers may provide you with medical care and more frequent health check-ups as part of your treatment.
• You may have the chance to help others get a better treatment for their health problems in the future.
• You may be able to get information about support groups and resources.
Risks of a Clinical Trial
• The new treatment may cause serious side effects.
• The new treatment may not work or it may not be better than the standard treatment.
• You may NOT be part of the treatment group (or experimental group) that gets the new treatment—for example, a new drug or device. Instead, you may be part of the control group, which means you get the standard treatment or a no-treatment placebo.
• The clinical trial could inconvenience you. For example, medical appointments could take a lot of time or you might be required to stay overnight or a few days in the hospital.
How Will My Safety Be Protected?
This is a very important question. The history of clinical research is not perfect. Based on many years of experience and learning, Congress has passed laws to protect study participants. Today, every clinical investigator is required to monitor and make sure that every participant is safe. These safeguards are an essential part of the research.
Researchers are required to follow strict rules to make sure that participants are safe. These rules are enforced by the Federal Government. Each clinical trial also follows a careful study plan or protocol that describes what the researchers will do. The principal investigator, or head researcher, is responsible for making sure that the protocol is followed.
An Institutional Review Board, or IRB, at each study site must approve every clinical trial in the United States. The IRB is made up of doctors, scientists, and lay people, like yourself, who are dedicated to making sure that the study participants are not exposed to unnecessary risks. The people on the IRB regularly review the study and its results. They make sure that risks (or potential harm) to participants are as low as possible.
Along with the IRB, many clinical trials are closely supervised by a Data and Safety Monitoring Committee. The Committee is made up of experts in your condition who periodically look at the results of the study as it is in progress. If they find that the experimental treatment is not working or is harming participants, they will stop the trial right away.
The informed consent process also helps protect participants. Before joining a clinical trial, you will be told what to expect as a participant and all the things that might happen. For example, someone from the research team will explain possible side effects or other risks of the treatment. As part of the informed consent process, you will have a chance to ask questions about the trial. The clinical trial coordinator will be happy to answer your questions.
After getting all this information, you can think about whether or not you want to participate. If you decide to join the trial, you will be given an informed consent form to sign. By signing the form, you show that you have been told all the details and want to be part of the study. The informed consent form is NOT a contract. You can leave the trial at any time and for any reason without being judged or put in a difficult position regarding your medical care. Researchers must keep health and personal information private.
North Bay Neuroscience Institute is engaged in a number of clinical trials or studies. All of them are researching new medicines designed to offset the impact of Alzheimer’s Disease.
We engage in clinical trials at either Phase II and III stages. Presently all of our trials are those in Phase III.
Our current studies are:
CREAD: Crenezumab for Prodromal to Mild Alzheimer’s Disease
Status: Closed and ending
Description: This clinical trial will test the experimental drug crenezumab in people with early to mild Alzheimer’s disease. Investigators will assess the drug’s safety and efficacy and evaluate any changes in participants’ dementia rating and performance on neuropsychological tests
EMERGE: Aducanumab (BIIB037) for Early Alzheimer’s Disease
Status: Closed and ending
Description: This study will evaluate the efficacy of the experimental drug aducanumab (BIIB037), compared with a placebo, in slowing cognitive and functional impairment in people with early-stage Alzheimer’s disease. Participants will receive monthly infusions.
GENERATION 1 & 2: CNP520 to Slow or Prevent Alzheimer’s
Status: Actively recruiting
Description: The Generation studies will test the safety and effects of the investigational drug CNP520 in cognitively normal older adults who are at risk of developing dementia based on their age, genetic Status:, and brain amyloid levels.
GRADUATE 1: Gantenerumab for Prodromal to Mild Alzheimer’s Disease
Status: Closed and ending
Description: This randomized, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of gantenerumab versus placebo in participants with early (prodromal to mild) AD.
We are dedicated to finding a solution to the Alzheimer’s Disease.
Our work, lead by Dr. Allan Bernstein (center) involves researching different potential medicines that may impact the onset of Alzheimer’s Disease. We work with pharmaceutical companies which are in various trial stages of developing these new drugs. Our job is to work with patients (subjects) who have early Alzheimer indications and want to try these trial drugs. Their participation in these studies helps us all understand ways to beat Alzheimer’s Disease.
Our team consists of Terry Hess, Director of Clinical Studies (pictured far left), Rich Speere, Clinical Trials Coordinator (pictured above Terry), Didi LaBue, RN (infusions) center/left, Dr. Bernstein, Lauren Weber, Clinical Trials Assistant (second from right) and Maben Rainwater, Institute Director (far right).
What we do:
• Assist study applicants in understanding their current status with Alzheimer’s Disease
• Review their options regarding any current clinical trials
• Screen applicants to insure their applicability for studies
• Following a successful screening, enroll them in a particular study as a subject
• Work with them during the study to monitor their progress and understand the study impact
• Close out the study for a subject with an understanding of its impact and any observations
• Report out any findings and results to the study sponsors and regulatory agencies
North Bay Neurosciences Institute is a Nonprofit Public Benefit Corporation incorporated in the State of California (C4150950). Our primary purpose is to conduct clinical research for a cure or treatment procedure for Alzheimer’s Disease and other dementia diseases.
About Alzheimer’s Disease
Alzheimer’s is a type of dementia that causes problems with memory, thinking and behavior. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks.
The information below has been provided by The Alzheimer’s Association. It is the leading voluntary health organization in Alzheimer’s care, support and research.
Alzheimer’s and Dementia Basics:
• Alzheimer’s is the most common cause of dementia, a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer’s disease accounts for 60 to 80 percent of dementia cases.
• Alzheimer’s is not a normal part of aging. The greatest known risk factor is increasing age, and the majority of people with Alzheimer’s are 65 and older. But Alzheimer’s is not just a disease of old age. Approximately 200,000 Americans under the age of 65 have younger-onset Alzheimer’s disease (also known as early-onset Alzheimer’s).
• Alzheimer’s worsens over time. Alzheimer’s is a progressive disease, where dementia symptoms gradually worsen over a number of years. In its early stages, memory loss is mild, but with late-stage Alzheimer’s, individuals lose the ability to carry on a conversation and respond to their environment. Alzheimer’s is the sixth leading cause of death in the United States. Those with Alzheimer’s live an average of eight years after their symptoms become noticeable to others, but survival can range from four to 20 years, depending on age and other health conditions.
• Alzheimer’s has no current cure, but treatments for symptoms are available and research continues. Although current Alzheimer’s treatments cannot stop Alzheimer’s from progressing, they can temporarily slow the worsening of dementia symptoms and improve quality of life for those with Alzheimer’s and their caregivers. Today, there is a worldwide effort under way to find better ways to treat the disease, delay its onset, and prevent it from developing.
GeneMatch is a national program led by the Banner Alzheimer’s Institute that provides information, gene testing and matches subjects to any number of clinical studies. It is free to use.
• Recruits participants for Alzheimer’s prevention studies.
• Uses genetic testing (through free cheek swab kits) to match volunteers with research opportunities.
• 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.
Brain Health Registry is a web-based, observational research study designed to effectively capture extensive amounts of data that may enable researchers to more efficiently identify, assess, and longitudinally monitor the cognitive changes associated with the progression of neurodegenerative diseases and brain aging.
• Participants in the Brain Health Registry complete online questionnaires and tests that, over time, provides researchers with valuable information and allows them to better track changes in an individual’s health, lifestyle, and cognitive function. These changes could potentially be important indicators of a person’s brain health and could help to best identify and recruit ideal candidates for medical research and future clinical trials. This is the first large-scale neuroscience project that leverages online possibilities in this way.
• By creating a large pool of pre-qualified potential participants, the Brain Health Registry can make clinical trials for neurological diagnostics and treatments faster, better, and more innovative – all of which may accelerate the discovery of effective treatments for brain disease and disorders, such as Alzheimer’s, Parkinson’s, depression, PTSD, and many more.