Internist and geriatric psychiatrist, and director, Banner Alzheimer’s Institute

Pierre Tariot, MD

“One thing we tend to overlook is the state of care because even if we have a marvelously effective disease ‘slower downer,’ or if we have a preventive therapy, there will still be millions of people affected. So, we and others need to keep raising the bar and the standard of care because…half or so of Americans with dementia don't have it recognized by a physician before they die—that's a tremendous opportunity to do better, and we have to.”

Discussing the recent controversial approval of aducanumab, Pierre N. Tariot, MD, director of Banner Alzheimer’s Institute, commented on the drug’s potential to “dominate the conversation” for the time being and the implications for research in the Alzheimer disease (AD) space. Specifically, the potential of biomarker outcomes and efficacy decisions being made earlier in drug development could shorten the length of trials in AD from spanning 6 years with 2000 patients, to 6 months with 100 patients, Tariot told 

Additional emerging therapies such as antisense oligonucleotides and mRNA silencing techniques were also discussed, which will require new and different drug administration, Tariot said. His commentary coincides with his recent presentation at the 

2021 Alzheimer’s Association International Conference

, held July 26-30, where he and colleagues presented safety data on the use of pimavanserin in dementia-related psychosis.

1. Tariot P, Cummings JL, Soto-Martin ME, et al. Trial of Pimavanserin in Dementia-Related Psychosis. 

. 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. 

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In addition to his work study pimavanserin in treating dementia-related psychosis, the director of the Banner Alzheimer’s Institute commented on the potential for aducanumab in Alzheimer disease.  

Aducanumab’s Implications for Future Clinical Trials: Pierre N. Tariot, MD

“I do believe in my heart, that our best chance of making real advances [in Alzheimer disease and related diseases] will be treating as early as possible. When you want to put the fire out? When it's a stove fire in the kitchen or when the house is in flames? I think the answer is obvious.”

Coinciding with his presentation on safety data for the use of pimavanserin in treating dementia-related psychosis at the 

2021 Alzheimer Association International Conference (AAIC)

, July 26-30, Pierre N. Tariot, MD, director of the Banner Alzheimer’s Institute (BAI), sat down with 

 to discuss prevention efforts within the Alzheimer disease (AD) space and hot topics discussed at the conference. 

Tariot commented specifically on the significance of blood biomarkers and spinal fluid, as well as the potential for early detection and treatment of AD. Tariot noted how “edgy” the research in blood biomarkers has become, as BAI recently announced a partnership with Eli Lilly in the TRAILBLAZER-ALZ 3 trial of the investigational monoclonal antibody therapy for AD, donanemab, which is recruiting patients based on age, a telephone screening interview, and a blood test.1,2 

Although treating patients already living with symptoms remains a top priority, presentations at AAIC 2021 further outlined additional advancements in imaging via digital technologies, making strides in the way experts evaluate patients’ changing brain health. These also may offer a way to leverage novel and current biomarkers to improve treatment approaches and timing.

1. Tariot P, Cummings JL, Soto-Martin ME, et al. Trial of Pimavanserin in Dementia-Related Psychosis. 

. 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. 

The director of Banner Alzheimer’s Institute spoke on the importance of biomarkers in Alzheimer disease, as well as the ongoing improvements in digital technologies.  

Biomarkers, Tech Advances to Improve Alzheimer Disease Prevention: Pierre N. Tariot, MD

“In partnership with us at the Banner Alzheimer's Institute, [Eli Lilly is] proposing a very large prevention trial [for donanemab], conducted as remotely as possible. So, we're hoping that will promote enrollment, we are hoping it will promote retention, [and] we are hoping it will promote engagement of typically more underrepresented groups, who won't have as much challenge having to travel and having to take time away from work or family.”

In an effort to make clinical trials in Alzheimer disease (AD) more patient-friendly, experts in the space are gravitating towards remote assessments and interactions, moving away from historically in-person methods following the onset of the COVID-19 pandemic. Pierre N. Tariot, MD, internist and geriatric psychiatrist, and director, Banner Alzheimer’s Institute (BAI), discussed the potential benefits of shifting towards a remote approach, namely anticipated increases in enrollment, retention, and population diversity within studies. 

Tariot commented on his involvement, as director of BAI, with the new prevention trial of Eli Lilly’s investigational monoclonal antibody therapy for AD, donanemab. In the recently announced partnership with BAI, investigators from Eli Lilly plan to conduct the phase 3 TRAILBLAZER-ALZ 3 trial “as remotely as possible,” Tariot said, evaluating the efficacy of donanemab in preventing clinical progression of AD. 

Commentary from Tariot coincides with his recent presentation at the 2021 Alzheimer’s Association International Conference (AAIC), which was held July 26-30. Alongside colleagues, Tariot presented safety data on the use of 

pimavanserin in treating dementia-related psychosis

. 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. 

Following the COVID-19 pandemic, investigators are seeing a shift towards remote trials in an effort to avoid participants having to be in-person at a brick-and-mortar site.  

Conducting Alzheimer Disease Trials Remotely: Pierre N. Tariot, MD 

“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 

, have necessitated further investigation into how to improve trial design and methodology. Sitting down with 

, 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 

1. Tariot P, Cummings JL, Soto-Martin ME, et al. Trial of Pimavanserin in Dementia-Related Psychosis. 

. 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. 

The director of the Banner Alzheimer’s Institute discussed areas of success and those facing challenges for Alzheimer disease clinical trials.

Pierre Tariot, MD

Articles

Aducanumab’s Implications for Future Clinical Trials: Pierre N. Tariot, MD

Biomarkers, Tech Advances to Improve Alzheimer Disease Prevention: Pierre N. Tariot, MD

Conducting Alzheimer Disease Trials Remotely: Pierre N. Tariot, MD

The State of Alzheimer Disease Trials: Pierre N. Tariot, MD

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