Stephen Peroutka, vice president and therapeutic area head in neuroscience, shares his thoughts on the importance and outlook of conducting clinical trials for Alzheimer’s disease.
Alzheimer's disease is a global epidemic with 47 million people living with dementia worldwide and 9.9 million diagnosed each year. World Alzheimer's Day is 21 September and serves to help raise awareness of this common form of dementia.
The aging process affects every organ in our bodies, from graying hair to the loss of general muscle strength. Through most of the signs and symptoms of aging, we can adapt well and still enjoy significant pleasure in the later stages of our lives.
However, cognitive decline is different. It is often difficult to adapt to decreasing cognitive function, though it is sometimes possible in instances when a caring partner, spouse or other family member can provide support that limits the problems associated with cognitive decline such as lost keys or missed appointments.
With severe memory loss, however, we lose many of the routine pleasures in life. Our friends and even our family members may become unrecognizable. We truly lose ourselves and our loved ones. Although Alzheimer’s is not a physically painful condition, the heartbreak of watching a loved one descend into the disorder is very painful.
Aging baby boomers and the successful development of medicines leading to longer life expectancies are expected to significantly increase the number of Alzheimer’s patients over the next few decades, which means conducting clinical research for Alzheimer’s disease is critical.
Alzheimer’s trial volunteers
But despite the increasing population of patients with Alzheimer’s disease, finding volunteers for trials remains, without doubt, a major challenge in today’s neuroscience research landscape. Although many patients have symptoms of the disease, and pharmaceutical companies and government agencies are investing heavily in clinical research, studies are difficult to enroll expeditiously.
The reasons for low enrollment and recruitment in these trials are numerous. Patients often fear the diagnosis of Alzheimer’s disease and many individuals with an early or mild form of the disorder may not realize they have the disease. Additionally, studies tend to be long, usually more than a year, and a patient’s caregiver is often needed to help the patient attend several visits and evaluations.
Clinical trial recruitment
Multiple attempts have been made to increase recruitment rates in Alzheimer’s trials, but none have proven very successful. A study from Johns Hopkins, for example, used online screening of 5,125 potential patients, but was only able to identify 13 with mild cognitive impairment.
In the future, I think we will continue to make small advances in Alzheimer’s research, as recent dietary and exercise recommendations appear to have a positive effect on patients with the disease. In the long term, a breakthrough is needed to modulate the aging process. The key may not be directly related to Alzheimer’s disease, but it could result in slowing the aging process. As many have concluded, the key is to die young at an advanced age!
Stephen Peroutka is a vice president and therapeutic area head in neuroscience.