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A Leap of Faith and Science: How to Choose a Clinical Trial
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Many individuals diagnosed with Alzheimer’s disease and their care partners and families seek out treatments that go beyond the modest symptomatic relief of current drugs to altering the progression of the disease.
Clinical trials are the final proving ground for new treatments under investigation. Each trial represents the result of years of creative scientific thinking, careful observation, laboratory study and data analysis. The large number of trials now under way demonstrates the vigor of the field and the strength of the dementia research network.
It is critical that diagnosed individuals and families seriously weigh the risks and benefits of any study before offering consent to a clinical trial. If you are seeking a drug or intervention to prevent, treat or alter the progression of Alzheimer’s, there are many questions to consider, including the following:
  • Are you eligible to take part in this study? Ask about the inclusion criteria – this includes parameters such as diagnosis, severity of disease and other exclusions (age, medical conditions, gender etc.). Although it can be discouraging to hear that you are not eligible to take part in a study because of your health history, age or stage of dementia, it’s possible there is another study out there for you.
  • Who is running the study and paying the bills? Some trials are paid for by drug companies and run at clinical trial centers. Others are run in University settings. Both can do excellent research – only you can decide which environment makes you feel most comfortable.
  • What phase is the trial in? Phase 1 trials are investigating safety of the drug and typically are given to paid volunteers. In these trials the researchers are not looking at the impact of the drug, just safety. Phase 2 trials look at both safety and impact of drugs in a small group of persons with Alzheimer’s disease. If found to be safe and effective, the drug or intervention goes on to Phase 3 clinical trials in which larger groups of people are studied with a careful review of the treatment’s impact and safety.  
  • What are the odds of receiving a placebo (an inactive, look-alike treatment)? In most cases, you will not know whether you received the actual drug or a placebo. After the conclusion of the study however, you may be eligible to have the experimental drug during the “open” phase. 
  • What are the numbers? Practical considerations to take into account include the number of subjects they are seeking, the dates and timeline of the study and the location. Some studies require frequent visits to the clinical center and you will want to determine if you are able and willing to make this commitment.

You can read more about choosing a clinical trial at www.alz.org/alzheimers_disease_clinical_studies.asp. The Alzheimer’s Association lists local studies seeking subjects here in our newsletter and on our website at www.alz.org/norcal. You can also visit www.clinicaltrials.gov for studies locally and nationwide.