Caring Currents

How to Decide on Enrolling a Family Member With Alzheimer's in a Clinical Trial

Last updated: Jan 31, 2009

Pipettes & test Tubes
Image by Goldmund100 used under the creative commons attribution share alike license.

Call it the great dementia-drug dilemma: In order to get new medications approved to treat Alzheimer's, scientists need clinical trials (tests) on volunteers who have the disease -- but to run the clinical trials, researchers need the very thing people with Alzheimer's are often incapable of giving, their informed consent.

Surprisingly, given the urgent need for such research, federal policy is fuzzy on how to proceed. Institutions interpret what's legally and ethically okay in different ways. (Though a federal panel is looking into the issue.) Often families are left to guess at what Mom or Granddad would really want if she or he could grasp all the particulars.

Now first-of-its-kind new research may help you make that decision. The overwhelming answer: Enroll me in the study.

University of Michigan researchers found that 68 to 83 percent of Americans age 51 or older would allow a surrogate (relative) to enroll them in a clinical trial in the event they lacked the cognition to make an informed decision themselves. (The range had to do with different ways they were asked.)

More help-you-decide tips:

  • Consider the big picture. Skipping a trial usually means continuing on approved meds that may slow the disease progress but won't stop it. Joining a trial means a shot at a promising treatment that otherwise won't be available for years -- but you won't know if you're getting the actual drug or a "dummy" pill (used to compare two groups of subjects, the standard procedure for so-called double-blind controlled studies). For some trials, you may not take already-approved meds. And you can't be sure of side effects, either.
  • Weigh all the pros and cons. These can range from free medical care (pro) to the hassle factor of getting to the test facility for frequent checkups (con).
  • Be sure you understand all the facts. What's the trial for? What's the hoped-for outcome? What all's involved?
  • Involve the person with Alzheimer's. Impairment doesn't necessarily mean complete incomprehension. The UM research reminded me of  a scene in the new novel Still Alice, where a woman with early-onset Alzheimer's, her husband, and her doctor are discussing whether she should enroll in a stage 3 clinical trial of a possible new drug. The doctor is open to all options, though leans to the trial. The husband, worried she'll just get a placebo, wants to try several alternative therapies. The woman herself chooses what she calls "the single bullet" (the trial) rather than a scattershot "shotgun" approach:

    "Ali, I think you should trust me here," said John.

    "I can still draw my own conclusions, John. I want to do the trial."

Every case is different, but every bit of information can help all of us make more informed decisions.