COMMENTARY

Helping Your Patients Navigate Dementia Trials

Richard S. Isaacson, MD

Disclosures

September 29, 2017

My name is Richard Isaacson. I direct the Alzheimer's Prevention Clinic at Weill-Cornell Medicine at NewYork-Presbyterian. Today we're going to present a case and try to walk you through some of the salient points about how to provide the best optimal care for Alzheimer's management.

A 62-year-old man comes in for a second opinion for previously diagnosed mild cognitive impairment due to Alzheimer's disease. This is a physician who retired a couple of years ago. About a year or two ago, he started noticing that he had some trouble remembering some of the facts of cases that were being presented to him on rounds. He worked in an academic setting. While he still could give diagnoses and interact with patients and medical students, he felt that as the cases were being presented to him, he couldn't remember some of the most important facts. In addition, he felt that in terms of his attention to detail, it wasn't as sharp as it should be for a practicing clinician. It's one of the reasons why he decided to retire a little bit earlier than he was anticipating.

He comes to me with a diagnosis of mild cognitive impairment due to Alzheimer's disease. Why? Because he previously had an amyloid-labeled PET scan that showed amyloid and because his short-term memory was impaired and his attention and speed of processing were impaired. He had a diagnosis of amnestic, mild cognitive impairment multidomain due to Alzheimer's disease because he had a positive biomarker test. He presents to me for an evaluation and for a second opinion.

What do you do in a case where you have a patient with mild cognitive impairment who may not be a candidate for some of the FDA-approved drugs, like the acetylcholinesterase inhibitors? In clinical practice, based on my clinical experience and based on discussion with a variety of other practitioners, often clinicians do tend to prescribe these drugs off label. However, you have to weigh the risks and benefits.

The other part is, what about a clinical trial? There are now several exciting clinical trials that are focusing on people who have a diagnosis of prodromal, or the very first stages, of the Alzheimer's disease spectrum. Back in 2011, there were new diagnostic criteria for Alzheimer's disease, including for the preclinical stages, which may go on for decades and where a patient has no symptoms but still has the pathology or amyloid, as one example, in the brain. Then there is mild cognitive impairment due to Alzheimer's disease. This is where a person still can take care of themselves but does notice specific changes in memory or other thinking skills, and they also have amyloid in their brain. The third stage is what we used to call dementia due to Alzheimer's. This is the stage where the person has amyloid in their brain and they can no longer take care of themselves.

In these pre-stages to dementia, like mild cognitive impairment due to Alzheimer's disease and prodromal Alzheimer's disease, there are now a variety of different studies that a person can be evaluated for. In this case, we already know that the patient has amyloid positivity on amyloid-labeled PET scan. This person would be an ideal candidate. I think it underscores that for state-of-the-art care, recommending that a person think about and be educated about clinical trials is key.

Some of the tips about trying to get a patient to learn more about clinical trials and to think about them for themselves is to give the person a list of different options. One of the sites that I use personally is clinicaltrials.gov. It's easy to search. You can search the name of the drug. You can search the different locations. That way, you can either do it yourself or have one of the people in your office give the [researchers'] contact information for that specific clinical trial (all found on clinicaltrials.gov) directly to the patient. I think that helps to get the person over the initial hurdle. At least you have a number to call-even giving the patient a couple of different numbers at different sites that are close in geographic location.

Even giving the person a variety of different study options is a good idea. I have patients who may call a study [center] and the center says, "No, I'm sorry, we don't have availability now. We can see you in 3 months." I have other patients who call a study center and hear, "I'm sorry, we just had some staff turnover; we can't evaluate you at this time." That can be very disheartening and discouraging for a patient. Giving patients multiple clinical trial options is one helpful tip.

The other part is to walk the person through the clinical trial protocols. Some studies may require a study partner to come every 3, 4, or 6 months. Other studies may be simple and have a pill. Other studies, however, do require an infusion. Whether you entertain a BACE inhibitor study or whether you entertain an infusion study with an anti-amyloid immunotherapy, these are some of the practical questions that you may want to talk about with a patient so that they are more in tune and more prepared to successfully screen for the study and also enroll in the future.

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