Is it appropriate to include Alzheimer’s disease patients in non-AD clinical research? Dr. Yaari, associate director of the Memory Disorders Clinic at Banner Alzheimer’s Institute, Phoenix, Ariz. Investigation studies for novel compounds treating Alzheimer’s disease (AD) require participation of people with the condition. Although some patients with early AD have capacity to provide their own informed consent, the majority of patients with AD have impaired decisional capacity requiring a surrogate to provide consent. It is common practice in AD studies to obtain consent from a legally authorized representative, usually a close relative, and an asset from the patient. Although imperfect, guidelines and processes have been developed to allow persons with diminished decision-making capacity due to AD to participate in clinical trials focused on treatments for AD. Participation in clinical trials provides numerous benefits to AD patients and their families, and in addition to current practice guidelines for AD, should be routinely offered as standard care. A clinical trial can provide a novel therapy for AD that may improve a patient’s condition, but these patients will suffer from co morbid medical conditions that often have a negative impact on cognitive functioning, quality of life of their caregiver. Clinical trials for conditions such as hypertension, hypercholesterolemia, and diabetes, just to name a few, can certainly benefit from including AD patients by aiding enrollment and improving the generalizablity and safety of the treatment. However, some compounds or procedures in clinical trials should exclude persons with AD if there is a significant risk of worsening the patient’s condition. During the course of a study, patients receive close (and free) medical monitoring in addition to social, educational, and behavioral support and problem solving that is typically not otherwise available. Most importantly, clinical trial participation provides not only hope, but an authentic sense of purpose that their efforts are a part of a larger picture in finding therapies that will help people in the future. Given that therapeutic trials in AD have proven the feasibility of conducting a trial in this population in terms of medication adherence, reporting of adverse events, and obtaining metrics of the treatment’s effectiveness, then in general, there should be no reason to exclude persons with AD from non-AD treatment trials so long as the patient has a reliable care partner and study partner.
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