This month’s expert is William J. Burke, MD, Director, Stead Family Memory Center at Banner Alzheimer’s Institute.
Dear Dr. Burke,
My Mom wants to volunteer for a double blind research study of a new medication for Alzheimer’s disease. I want to make sure she’s in the group that’s taking the medication being studied, not the placebo. Can we make this request?
As an Alzheimer’s disease researcher, potential study participants often ask me this question. And while I appreciate why people would want to receive the study medication, I have to tell them that researchers cannot fulfill this request.
The reason for this goes back to why researchers pursue these studies. Medical research studies – for Alzheimer’s disease and all conditions – begin with a question: Is this an effective medication, therapy, procedure or prevention strategy? If the researchers knew the therapy was effective, it would be unethical to pursue a study. The opposite also is true. It would be unethical for researchers to undertake a study they knew would fail.
A double blind study – which includes a placebo or comparison group – allows for objective and ethical research. The alternative is to use a simple observation method.
Observation occasionally gives researchers the right answer but very often it’s misleading.
It’s also important to know that the study’s researchers do not know which study participant is assigned to which group. Before they are assigned to the study medication group or the placebo group, study participants’ names are pooled and randomized. People are then assigned a group using a method that’s the electronic equivalent of drawing numbers from a hat.
While you didn’t ask, you may be wondering if your mother can remain on any current Alzheimer’s medication she’s taking during the research study. Researchers work to keep people taking medications that may be effective for them, but typically they want all study participants to take the same medication so they can compare similar groups of people.
Check with the research team about this.
Getting involved in Alzheimer’s disease research is very admirable and extremely important. My thanks to your mother, Linda.