The role of clinical trials and the importance of counseling patients on trial enrollment and lifestyle interventions in the management of Alzheimer disease.
Ronald C. Petersen, MD, PhD: I think how the field has advanced in the last few years with regards to the design of clinical trials is that we’ve made the entity much more personalized now. We used to just enter people into an Alzheimer disease clinical trial if they met the clinical criteria: Forgetfulness— “I’m not thinking so well.” “It’s been slowly progressive over time.” “It affects my daily function.” We look around for other things: Brain tumors, strokes. If we don’t find those, we say, “Ah-ha, it must be Alzheimer disease.”
Well now, with our biomarkers we can in fact determine whether somebody with that clinical picture does in fact have the amyloid protein in the brain, and does have the tau protein in the brain. So now clinical trials are being designed, for example… If they have amyloid as the target, people have to show the presence of amyloid in the brain, either by imaging or by cerebrospinal fluid, before they get entered into the trial. So that’s a big, sophisticated step that has helped the design of these therapies, such that we can now measure whether in fact the therapies are working. We have a pretreatment index of the protein of interest—let’s say amyloid. We treat them for 12 to 18 months. We can measure the amount of protein in the brain after the treatment and determine whether, in fact, it was biologically active.
When we make the diagnosis of cognitive impairment, be it mild cognitive impairment, be it dementia, we talk to people about what might be the prognosis down the road. They always ask a relevant question: “But what can I do about it?” Certainly here, we start with the discussion around clinical trials. So we might make you eligible for a clinical trial for a pharmacologic intervention. But we also talk about lifestyle interventions. We talk about the person’s exercise pattern. “Are you getting out there and spending some time with aerobic exercise, be it walking, or jogging, if you want to, or swimming, or something of that nature—ballpark figure, 150 minutes a week, or 50 minutes at 3 times, or 30 minutes at 5 times?” But get out there and actually be active. So physical exercise can, in fact, delay the onset of cognitive impairment to a certain extent. I’m not saying it’s going to prevent Alzheimer disease, but it can delay the onset and slow the progression.
Similarly, we talk about remaining intellectually active. So here we’re talking about going to plays, discussing things, reading the newspaper, watching the news on TV, going to lectures, things of that nature, or maybe using some of these games that are out there, or going to training exercises for cognitive function. I’m not going to say that brain game A is better than brain game B, but, nevertheless, those kinds of activities are probably beneficial. So, intellectual activity.
We encourage people to eat a heart-healthy diet. We encourage a Mediterranean-type diet. Something that’s good for the heart is probably good for the brain. And then, finally, we encourage patients to stay involved in their social networks. So don’t pull back. Don’t withdraw. Don’t stay at home all the time. Get out there with your friends and families, go to lunch, go to dinner, and interact socially. Those kinds of activities can be important in improving quality of life for people with cognitive impairment, and may slow down the progression of these underlying processes.