What is a clinical trial for Alzheimer's disease?
Intensive activity is taking place at labs worldwide to find new treatments, or a cure, for Alzheimer's disease. In order to prove a new drug or therapy works, it must be rigorously tested on real people with the disease. Clinical trials are research studies on the safety and effectiveness of promising new therapies, especially drugs.
Participating in a clinical trial depends on several factors:
- Logistics: You'll need to be able to find a clinical trial near your friend or relative's home (most likely in urban areas or university towns).
- Eligibility: Subjects will need to be a particular age or in a particular stage of disease, have a certain medical background (for example, medication history may be a factor), or meet other requirements.
- Personal preference: Is the person you're caring for willing to join a clinical trial? Are you willing and able to go through the work involved in helping him participate? Are you both comfortable with his participating in an experiment?
How do clinical trials work?
Every clinical trial is different. A trial may test an experimental therapy or a new use for an existing therapy. A new drug might be tested against a placebo (a sugar pill containing no medication) or against a current therapy. Some studies compare people at various disease stages, or people with a family history of the disease or those with a certain variety of the disease (such as early Alzheimer's).
Subjects are all volunteers. First, the volunteer is screened to see if he's a good match for the study's needs. In a typical Alzheimer's trial, once accepted he'll have a baseline visit to establish where his health, memory, and cognition stand. Then he'll take, say, a pill as requested, without knowing whether it's the actual drug or a placebo. Next he'll be monitored periodically through a variety of tests, including blood work, MRIs, and other general-health assessments. Trials can last a few weeks or years.
Clinical trials are usually sponsored by the federal government or pharmaceutical companies. They're executed by clinicians at federal research centers, universities, or teaching hospitals, or at private medical research and care facilities.
Should the person in your care participate in a clinical trial for Alzheimer's?
- Treatment. The person in your care may have the first shot at a useful new drug or therapy.
- Healthcare. He'll get access to free, high-quality medical monitoring, both for Alzheimer's and for his general health.
- Activity. It gives him something to do and look forward to, and he may be reimbursed for time or travel expenses.
- Support. Caregivers and partners may find a support network and outlet.
- Providing help. Whatever the outcome, as a volunteer he'll be helping to advance the cause of finding effective treatments and a possible cure.
- Placebos. He may receive the placebo, and thus gain no cognitive or health benefit. (Many trials don't want people who have begun the existing Alzheimer's medications, so he risks receiving no drug therapy at all.)
- Side effects. All medications have side effects (dizziness, diarrhea, and so on, including serious ones like cardiac arrest, allergy, or -- rarely -- even death).
- Inconvenience. There can be a large hassle factor: returning to the trial site frequently for tests (blood work, brain scans, and the like) and monitoring.
- Privacy issues. He should be prepared to provide considerable personal information (medical history, cognitive history; sometimes family members are asked to be involved as well).
- Disappointment. "Miracle" responses are rare, which can disappoint those whose expectations are not realistic.
What to know before he signs on
Legally: Informed consent is required. If your friend or relative is past the point of being able to provide it, it may be possible for a legal representative to give consent, although laws vary by state.
Logistically: Find out exactly what is required of participants: Where is the trial? How often will he need to appear in person, and for how long? What does the subject need to do specifically, and is that practical for everyone involved?
Practically: Find out as much as you can about what is being tested and how, what are the expected or possible outcomes, what phase of testing it is (the higher the number, such as Phase 3 or Phase 4, the more research on humans has taken place), who will be overseeing care, who you should call with questions as they arise.
How to find a clinical trial
The National Institute on Aging and the U.S. Food and Drug Administration together run the Alzheimer's Disease Clinical Trials Database, where you can search for trials by location.Your friend or relative's doctor or the local Alzheimer's Association may know of current recruiting for trials at nearby universities or other research centers.