What is the purpose of the trial?
How does the study relate to me?
How long will the trial last?
Is there a chance I will be on placebo?
Will I be able to take my regular medications during the study?
How will I be monitored for side effects?
Are there any risks involved?
What are the possible benefits?
Who is sponsoring the trial?
Are there any costs to participation?
Frequently Asked Questions
Frequently Asked Questions
Q: What Is Alzheimer’s Disease?
Alzheimer’s disease is the most common form of dementia. Alzheimer’s disease causes irreversible and progressive degeneration of brain tissue. Individuals most commonly present with cognitive impairment in the form of mild memory loss. This early stage is known as Mild Cognitive Impairment or MCI. This can progress to worsening cognitive impairment affecting language, orientation, insight and reasoning. The dementia stage of Alzheimer’s disease occurs when the extent of cognitive impairment interferes with the individuals’ ability to be independent in their work or daily functions. Psychological symptoms such as depression, anxiety and agitation are often present. Onset is most common after the age of 65 but can occur in individual’s in their 40’s or 50’s. Currently approved treatments can help with symptoms but unfortunately we have no medications that slow down this fatal disease.
Q: What Are Amyloid Plaques And Tau Tangle?
Alzheimer’s disease is caused by the accumulation in the brain of amyloid protein plaques and tau tangles. These plaques and tangles are responsible for brain cell death. This process begins approximately 20 years before symptoms become evident. The memory center of the brain, the temporal lobe, is most commonly affected first. Symptoms worsen as the plaques and tangles spread to other parts of the brain. Medications being evaluated in current clinical trials are trying to slow down this process. However, there is still much that we do not know about Alzheimer’s disease and a significant amount of research is taking place to better understand its root causes.
Q: What Is The Toronto Memory Program Clinical Trial Site?
Toronto Memory Program is Canada’s largest and most experienced site for Clinical Trials in Alzheimer’s disease and related conditions such as vascular dementia. Founded in 1996, we have made significant contributions to over 100 Clinical Trials in Alzheimer’s disease. Our Medical Director, Dr. Sharon Cohen, a Canadian-trained behavioral neurologist, along with her team of highly trained research staff, have been committed to the development of better treatments for dementia for the past 20 years. Toronto Memory Program participates in international Clinical Trials providing individuals the opportunity to try medications under study for their potential to improve symptoms and/or slow down Alzheimer’s disease. All Clinical Trials at Toronto Memory Program are conducted according to national and international regulations and codes of conduct, and are approved by independent Research Ethic Boards. Toronto Memory Program’s work has been frequently audited for quality and safety due to its leading role in Clinical Trial recruitment. We achieved outstanding results during a successful Health Canada audit.
Q: What Are Clinical Trial Education Sessions?
The process begins with an educational session. You and your study partner will meet with research staff at our facility. Our staff will explain the nature of study participation in detail as well as the specifics of any study of interest. This includes a discussion of the purpose of the study, the possible risks and benefits, and the time requirements of participation. You and your family will have the opportunity to ask questions and receive answers from experienced research professionals.
Q: What Is The Clinical Trial Screening Phase?
If you wish to join a Clinical Trial, screening is essential to ensure that the study is a good fit for you. The first step is to review in detail with you, and your study partner, the approved Informed Consent Form (ICF). The ICF contains, in writing, detailed information that a Research Ethic Board has decided you need to know to make a decision about participation. The ICF will also describe the privacy of your medical records. If you agree to take part in the study you will be asked to sign the ICF. Once the ICF is signed, you are free to continue to ask questions and can decide to leave the study at any time. During the screening process, your general health and medications will be reviewed. You will also undergo memory tests to determine the extent of cognitive impairment, a physical examination, blood tests and an ECG. A scan of the brain may also be ordered. All of these tests will be performed in a short time frame and at no cost to you.
Q: What Is The Clinical Trial Treatment Phase?
Following successful screening, you will start taking study medication. Most Clinical Trials are designed to compare a new treatment for cognitive impairment with a placebo (inactive substance). These details will have been carefully explained to you and your study partner, as part of the ICF. A schedule of study visits will be provided. At each visit, your medical status will be reviewed and you will have assessments to track your progress. Your safety is an absolute priority, therefore it is important to follow your visit schedule and the instructions from the research team closely. At each visit, you will be asked about how you are feeling and whether there have been any changes to your health or prescribed medications. While enrolled in a Clinical Trial, you will continue taking your regular medications including medications specifically prescribed for Alzheimer’s disease. We will keep your family doctor informed of your progress through regular faxed reports. Any Clinical Trial information that we provide to a pharmaceutical company, Health Canada or other regulatory body will not include your name to ensure your privacy. Any information about you, collected as part of the study, remains confidential. Results of the study you are involved in will be shared with you as they become available.
Q: What Studies Are Currently Being Offered?
Q: Is There Treatment For Alzheimer’s disease or FTD?
Currently approved medicines have modest benefit for symptoms of Alzheimer's disease. They do not prevent, cure, or slow down the underlying disease. Nonetheless, promising treatments are under evaluation for their potential to slow down Alzheimer’s disease as well as to treat symptoms more substantially. For rarer diseases like Frontotemporal dementia (FTD) there are no approved medications specific for symptom control or disease progression.
Q: What Is A Drug Treatment Trial?
A drug treatment trial is a carefully designed study in which people like you volunteer to receive an investigational drug (a drug under development and not yet on the market) under close supervision by a study doctor. Drug treatment trials are conducted in order to develop new treatments. In the case of Alzheimer’s disease and related dementias, new treatments are urgently needed. Drug treatment trials provide the information needed on how effective and how safe a new treatment will be. Drugs which perform well may then be eligible for approval so that they can be prescribed outside of the research setting.
All drug treatment trials are conducted with the approval of Health Canada’s Therapeutic Products Directorate (the Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use) and the oversight of an Ethical Review Board.
Q: Is A Drug Treatment Trial Right For Me?
In order to decide whether a drug trial is right for you or a loved one, a study doctor and study coordinator from Toronto Memory Program will meet with you to discuss the trial opportunity. Joining a clinical trial is an exciting option. Patients and families generally find participation extremely valuable.
Q: Who Is Eligible?
Each drug treatment trial follows a protocol that outlines, among other things, who is eligible to participate. This ensures that those participating are the appropriate individuals to receive study medication. Your medical diagnosis, general health, and the medications you are taking are some of the factors which will help determine your eligibility for a particular study.
Q: What Are The Benefits and Risks of Participation?
By participating in a drug treatment trial you are playing a major role in bringing new treatments forward.
Possible Benefits:
Access to promising medication not otherwise available.
Expert medical care by individuals dedicated to the treatment of Alzheimer's disease, frontotemporal dementia, and related conditions
Opportunity to help others by contributing to medical research
Possible Risks:
New treatments may have side effects that are not yet known. Your health will be closely monitored for the emergencies of any side effects.
Notes:
Participants may withdraw from a drug treatment trial at any time and for any reason. Withdrawing will not affect the medical care provided by Toronto Memory Program physicians.
Q: What Questions Should I Ask?