Clinical Trials for Alzheimer’s and Dementia: A BrightFocus Interview with Mario Cornacchione, DO

Mario Cornacchione, DO, recently joined BrightFocus Foundation, the parent organization for Alzheimer’s Disease Research, in a Scranton PA community forum on Alzheimer’s and caregiving. Dr. Cornacchione is a practicing physician and is also working with several clinical trials. What follows is a brief question and answer session between BrightFocus and Dr. Cornacchione.

What do your clinical trials do?

The worldwide clinical trials we participate in are studies of the effectiveness and safety of new medications for the potential treatment of Alzheimer’s disease and mild cognitive impairment, a frequent precursor to Alzheimer’s disease. We currently are helping study 7 different medications some of which may truly alter the course of the disease by preventing, delaying the onset or slowing the progression of the disease. Not only do we study the effects of the medications on memory and other cognitive processes but also on the person’s quality of life. Additionally, we utilize a study partner, usually a family member, in assessing how the patient is doing as well. Most of our trials are the final step in the study of a medication that, if effective, will be submitted to the FDA for approval as a treatment.

Why are clinical trials important?

The currently approved medications for Alzheimer’s disease can help reduce the symptoms for some people however there are no medications available which prevent or meaningfully alter the course of this devastating disease. We need patients to participate in these trials since participation of significant numbers, 800- 1000 patients, are required in each study to tell if a medication is truly effective. We will not find an effective treatment without the willingness of patients and families to participate.

What advice would you give to someone considering volunteering for a clinical trial?

Thoroughly discuss your potential participation in a trial with the physician in charge of the trial and your family. That discussion should include the potential benefits and any risks of participation as well as the length of the study, frequency of visits for cognitive testing, visits with the physician, and imaging such as MRI, PET scans or spinal fluid analysis, all of which vary depending on the specific study. Make sure you are given a copy of the informed consent, a document which you would eventually sign prior to starting your screening for participation in the trial, to read at home at your leisure. Make sure all of your questions are answered.

Consider the big picture of your participation in a clinical trial. Patients frequently tell me they are not only considering or deciding to participate in a clinical trial for their own benefit but for those who follow them who will develop the disease in their own families as well as in the rest of the world.

Is there a misperception that the public has about clinical trials that you would like to correct?

1. That there is a cost to the patient or any billing to their insurance. Clinical trials are at no cost to the patient and there is no billing to their insurance since all trials are funded by the pharmaceutical company who has developed the medication being studied.


2. That there is no compensation for their time to participate. Nearly every trial compensates the patient and study partner for clinic visits and visits for imaging studies.


3. There is no value to being on placebo rather than the actual medication. Either way you are contributing to finding an effective treatment for Alzheimer’s disease. In some studies 50% of patients are randomly assigned to receive placebo (sugar pill or salt water IV infusion depending on the specific trial) and 50% the actual medication. In some studies only 25% or 30% of patients receive placebo and 70% or 75% receive the medication. Neither the patient, physician, site research staff or the pharmaceutical company know what you are receiving so as not to influence the results of the trial. It is only possible to tell if the medication is working by comparing the response of patients on the medication to those on placebo.

Are you hopeful for the future of Alzheimer’s research?

Although the research community, patients and families have been disappointed over recent years regarding the lack of effect of the medications studied, I believe we are closer than ever before to finding an effective treatment. Through the ongoing basic science research and the clinical trials that result, increasing public awareness of this public health crisis and the need for patients to participate in clinical trials, and moves toward an increase in funding research, I am confident we will find an effective treatment.

This series of articles promoting awareness of clinical trials is supported in part by an educational sponsorship from Biogen. BrightFocus is solely responsible for the content of this article.