Registry FAQ
What is the Research Registry?
Do I need to make an appointment to get in the Registry?
If I enroll in the Registry, will you talk to my doctor?
Who will have access to my information once I am enrolled in the Registry?
Will my family members have access to my information once I am enrolled in the Registry and/or participating in a clinical trial?
How do I get out of the Registry if I change my mind?
Research FAQ
What types of studies are currently available?
Can I take my medications for Alzheimer's disease while participating in a study?
Once I meet all the criteria, where will I go to participate in the study I select?
Why should I participate in research studies?
What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
Clinical Trial FAQ
What does the term clinical trial mean?
Who can participate in clinical trials?
Who monitors clinical trials?
What is a placebo?
What is a double-blind study?
What is the difference between a vaccine study and a medication study?
Once I am enrolled and I am participating actively in one of the trials, am I guaranteed to receive a drug?
Will I get to continue taking the study medication after my participation in the trial ends?
Can I participate in more than one clinical trial at a time?
Can I participate in another clinical trial after I complete a trial?
What happens if I become ill or experience risky side effects during my participation in a particular clinical trial?
How long will my participation in clinical trials last?
Will I get paid for my participation in clinical trials?
Is there a fee for me to participate in clinical trials?
Alzheimer's Consortium FAQ
Who is included in the Consortium, and what do they do?
Who sponsors the Consortium?
What if I only want to participate in research studies at certain Consortium sites?
Alzheimer's Disease FAQ
Are there any treatments for Alzheimer's disease? Do any of those treatments really work?
Should I have genetic testing?
Should I have an evaluation for dementia?
What is a PET scan?
Other FAQ
What if I am interested in donating my brain or body to science?
What if I want to make a donation to the project?
What if I want to volunteer my services instead of participate in studies?
Registry FAQ
What is the Research Registry?
The Arizona Alzheimer's Consortium Registry is a database created to match people willing to participate in clinical research with studies that match their interests. Because each study is unique, participants will be further evaluated on a case-by-case basis beyond their initial enrollment in the Registry to assist with determining participation eligibility.
Do I need to make an appointment to get in the Registry?
No, you do not need a formal appointment to get your name into the Registry. However, once formally enrolled in a clinical trial, you can expect to make multiple appointments throughout the duration of the study.
If I enroll in the Registry, will you talk to my doctor?
No. Enrolling in just the Registry alone will not create a need for us to contact your doctor or any of your healthcare providers. However, if you become formally enrolled in a clinical study, we will likely require medical records. If this is necessary, you will be advised in advance.
Who will have access to my information once I am enrolled in the Registry?
All information contained in the database is secure, and is utilized by only by the Registry team. Both the Arizona Alzheimer's Consortium and the research institutions follow strict federal HIPAA guidelines.
Will my family members have access to my information once I am enrolled in the Registry and/or participating in a clinical trial?
No. Only the person you specify as your primary contact at the time of your enrollment can ask questions about your enrollment and/or participation. You may change this designation at any time, and you should notify us if that occurs. All enrollees must have a study partner, who will accompany them to all visits to be eligible to participate in clinical studies.
How do I get out of the Registry if I change my mind?
Participants may decide to leave the Registry at any time. If you change your mind, you can call us at 602.239.6500 and we will remove you from the list. You can also write to us at: Alzheimer's Research Registry, 901 E. Willetta St., Phoenix, AZ 85006.
Research FAQ
What types of studies are currently available?
New studies will continue to be added over time, but the current studies available include three main categories:
- studies of new agents to try to help individuals think and remember better
- studies of agents to try to slow the progression of Alzheimer's disease
- studies of agents to try to relieve associated symptoms, such as sleep/wake disturbance
Can I take my medications for Alzheimer's disease while participating in a study?
Yes.
Most studies do permit the use of current treatments already in place.
Once I meet all the criteria, where will I go to participate in the study I select?
All of the studies conducted within the Consortium will be in and around the metro-Phoenix and Tucson areas. Transportation to and from these studies is not necessarily provided. You will be provided with the study site location and all the details prior to your first appointment.
Why should I participate in research studies?
Participants volunteer for different reasons. Some volunteer because they want to better their own medical knowledge, while others volunteer because other traditional therapies have failed for them. Many participate hoping that their participation will lead to the approval of future treatments or preventive therapies.
What kind of preparation should a potential participant make for the meeting with the research coordinator or doctor?
- Plan ahead and write down possible questions to ask.
- Ask a friend or relative to come along for support and to hear the responses to the questions.
- Bring a tape recorder to record the discussion to replay later.
Clinical Trial FAQ
What does the term clinical trial mean?
Clinical trials are scientifically controlled studies of the safety and effectiveness of therapeutic treatments (such as drugs, medical devices, or biologics such as a vaccine or gene therapy). These studies are used to determine if these treatments/devices.procedures should be approved for wider use in the general population. Clinical trials are an important step in the development and discovery of a new treatment and must be approved by the Food and Drug Administration (FDA). The FDA is committed to ensuring that the safety of participants is protected.
Who can participate in clinical trials?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on factors such as age, gender, type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject anyone personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible. An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.
What is a placebo?
A placebo is a harmless substance (such as an inactive pill, liquid, or powder) used in controlled experiments and tests the efficacy of another substance (such as a drug or a vaccine.) In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.
What is a double-blind study?
A double-blind clinical trial is an experimental procedure in which neither the subjects nor the experimenters know which subjects are in the test and control groups during the actual course of the experiments.
What is the difference between a vaccine study and a medication study?
A
vaccine study's goal is to train the body's immune system to fight back against Alzheimer's disease (or other condition/disease the vaccine is designed to test.) The hope is that individuals participating in the vaccine study will strengthen their immune system, which will then mount a response against beta amyloid. Amyloid plaque is a key pathological feature of Alzheimer's disease. The main component of a plaque is the beta-amyloid protein fragment, which may be the main toxic factor damaging cell-to-cell communication and causing the loss of cells. A large effort in Alzheimer research is to develop treatments that clear beta-amyloid and amyloid plaques from the brain. A
medication study assesses the effects of a particular medication, with the aim of either improving cognitive function or slowing its decline over time. Some medications are designed to help improve memory and thinking, others are designed to alter the progression of the illness.
Once I am enrolled and I am participating actively in one of the trials, am I guaranteed to receive a drug?
There are a few studies, which will compare whether or not one drug or other therapeutic intervention is better than another. However, most studies are placebo-controlled.
Will I get to continue taking the study medication after my participation in the trial ends?
Some studies have an open-label extension, which is an extension to the main study, but offers the participants the un-blinded active study medication. Other studies do not have an open-label extension, so the participant will no longer receive study medication at the end of their participation.
Can I participate in more than one clinical trial at a time?
No. You can participate in only one intervention study at a time so that the efficacy of the substance being tested will not be confused with the effects of another intervention. It may be possible to volunteer for an observational study and an interventional study simultaneously. For additional information on clinical trials, please visit:
http://www.clinicaltrials.gov
Can I participate in another clinical trial after I complete a trial?
Yes. Typically, most clinical trials will allow a participant into another clinical trial after a period of 30 days upon completion of the previous clinical trial.
What happens if I become ill or experience risky side effects during my participation in a particular clinical trial?
All research studies are designed to benefit the patient and minimize risk. However, there are certain risks involved with each study. Emergency procedures are taken very seriously. Participants in clinical trials receive careful monitoring by a physician and clinical trials staff. If a participant experiences any sort of health-related emergency during the course of clinical trials, they will be removed from the study immediately. Because many of the studies with the Arizona Alzheimer's Consortium institutions are placebo-controlled or double-blind, we assume that each participant is receiving an active treatment so that the attending physician and study staff can react quickly and appropriately should an emergency arise.
How long will my participation in clinical trials last?
Every clinical trial is designed to address specific research questions. Duration of participation in clinical trials varies greatly depending on the type of study being conducted. Specific procedures are performed at specified time-points during the course of a clinical trial. Once you are formally enrolled and committed to a particular study, you should expect to participate anywhere from several weeks to several years.
Will I get paid for my participation in clinical trials?
Each study conducted by the Arizona Alzheimer's Consortium institutions will vary greatly and compensation and/or reimbursement will be dependent upon the study's sponsor(s). Generally, however, participant compensation for participation in clinical trials is minimal and typically only covers costs such as mileage.
Is there a fee for me to participate in clinical trials?
No. Participants receive study-related monitoring by a physician, study medications, and laboratory services for free for the duration of the study.
Alzheimer's Consortium FAQ
Who is included in the Consortium, and what do they do?
The Arizona Alzheimer's Consortium (AAC) is a statewide laboratory without walls dedicated to the scientific study, early detection, and prevention of Alzheimer's disease. It includes more than 100 researchers from eight Arizona institutions, including Banner Health, the Sun Health Research Institute, the Barrow Neurological Institute, the Mayo Clinic, the Translational Genomics Research Institute, the Southern Arizona Veterans Administration Medical Center, Arizona State University, and the University of Arizona. The Consortium includes the state-supported Arizona Alzheimer's Research Center and the National-Institute on Aging-sponsored Arizona Alzheimer's Disease Core Center.
Who sponsors the Consortium?
The Consortium is sponsored by state and federal funds and by those participating institutions named above. Specific studies conducted throughout the Consortium are funded by state and federal funds, by pharmaceutical corporations and by public and private dollars.
What if I only want to participate in research studies at certain Consortium sites?
There is a section on the questionnaire that we will be sending you that asks about what locations you would be interested in traveling to for research visits. We will only match you to studies at the locations you indicate you are interested in.
Alzheimer's Disease FAQ
Are there any treatments for Alzheimer's disease? Do any of those treatments really work?
There are currently five medications approved for treating Alzheimer's disease. Those drugs include Cognex, Aricept, Razadyne, Exelon, and Namenda. Cognex is rarely used due to liver complications. Donepezil (Aricept), Galantamine (Razadyne), and (Rivastigmine) Exelon are known as cholinesterase inhibitors which work to increase levels of acetylcholine, a chemical messenger involved in memory, judgment and other thought processes. Memantine is different from the other medications in that it appears to work by regulating the activity of glutamate, one of the brain's specialized messenger chemicals involved in information processing, storage and retrieval.
Should I have genetic testing?
Genetic testing is something that you should discuss in-depth with your medical provider.
Should I have an evaluation for dementia?
A dementia evaluation is something you should discuss in-depth with your medical provider. Should you be selected for a particular clinical trial, a dementia evaluation may be included during the study.
What is a PET scan?
A PET (Positron Emission Tomography) scan is a procedure in which a small amount of radioactive glucose (sugar) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the glucose is used. PET scans show the difference between healthy and abnormally functioning tissues and can illuminate the changes in a brain that has memory impairment.
Other FAQ
What if I am interested in donating my brain or body to science?
Brain and body donations are important aspects of biomedical research. There are a variety of options in brain and whole body donations, and it is wise to explore your options. As a Consortium partner, Sun Health Research Institute has an internationally acclaimed brain and body donation program. For more information, please contact us at 602.239.6500 if you would like additional information on this topic.
What if I want to make a donation to the project?
Donations are always welcomed and encouraged, and funds will stay within the Consortium Registry to promote education and awareness. For more information on monetary donations and planned giving, please contact Hazel Richards at the Banner Alzheimer's Foundation located at 901 E. Willetta St., Phoenix, AZ 85006. Or please contact us at 602.239.6500.
What if I want to volunteer my services instead of participate in studies?
Volunteers are very important to our work. If you would like to volunteer your time, please contact us at 602.239.6500 for more information on volunteer opportunities.
Some content adapted from
www.clinicaltrials.gov You can visit their Web site for more information.