The director of the Banner Alzheimer’s Institute discussed areas of success and those facing challenges for Alzheimer disease clinical trials.
“As I reflect on the last 5 years or so, I'm struck by the rapid increase in prevention trials, number 1—that used to be a pipe dream, and now it's a possibility. We can actually study people who are at high imminent risk of getting symptoms, but don't have symptoms yet, either based on their genetics and age or biomarker characteristics, and then treat with plausible experimental therapies to see if we can delay the onset of or, maybe, theoretically, prevent symptoms all together.”
Trials within the Alzheimer disease (AD) space present unique challenges, and ongoing conversations following the controversial approval of aducanumab, have necessitated further investigation into how to improve trial design and methodology. Sitting down with NeurologyLive, Pierre N. Tariot, MD, internist and geriatric psychiatrist, and director, Banner Alzheimer’s Institute, discussed advancements in trials in recent years, as well as areas in need of improvement.
For Tariot, the biggest innovation has been the increase in prevention trials to study those who may be at high risk of developing AD symptoms, but may not be presenting them yet, via genetics or biomarker testing. Additional areas of interest included the length of trials, which he described as “daunting,” in that they can span 5 to 8 years, as well as the management of neuropsychiatric features that are often present for patients with AD. Tariot’s commentary follows the 2021 Alzheimer’s Association International Conference (AAIC), held July 26-30, where he and colleagues presented safety data on the use of pimavanserin in treating dementia-related psychosis.1,2
For more coverage of AAIC 2021, click here.
1. Tariot P, Cummings JL, Soto-Martin ME, et al. Trial of Pimavanserin in Dementia-Related Psychosis. N Engl J Med. 2021; 385:309-319. doi: 10.1056/NEJMoa2034634.
2. Demos G, Foff EP, McEvoy B, Skoog B. Pimavanserin and concomitant antidementia medication use in patients with neurodegenerative and/or neurovascular disorders: safety outcomes from pooled clinical data and the HARMONY study. Presented at: AAIC 2021; Denver, Colorado; July 26-30. Poster 57661.