Jeffrey Cummings, MD, ScD

“There’s always a lot to be learned even if that drug itself is never approved as a treatment for Alzheimer’s.”

A systematic review of Alzheimer disease (AD) agents within the clinical pipeline during 2020 revealed an alarming 57 trials, containing 52 repurposed agents across all phases. Among them 9 (16%) trials were by biopharma industry, 42 (74%) trials were hosted by academic medical centers, and 6 (11%) trials were by other entities.

The study, led by Jeffrey Cummings, MD, ScD, director emeritus of the Lou Ruvo Center for Brain Health at Cleveland Clinic and vice chair of the Department of Brain Health at the University of Nevada-Las Vegas, also 

showed a substantially greater amount of repurposed agents

 by academic medical centers in phase 2, compared to phase 3, which was heavily dominated by biopharma. Repurposed agents have promise to accelerate drug development because the results of non-clinical studies, dosing, safety, tolerability, formulation, manufacturing, and distribution are already known.

, Cummings shares his thoughts on the role repurposed agents have within the pipeline, and whether research has trended towards observing more of these agents compared to other therapies.

Cummings J, Lee G, Ritter A, Sabbagh M, Zhong K. Alzheimer’s disease drug development pipeline: 2020. 

. Published online July 16, 2020. doi: 10.1002/trc2.12050

Videos

The director emeritus of the Lou Ruvo Center for Brain Health at Cleveland Clinic and vice chair of the Department of Brain Health at the University of Nevada-Las Vegas discussed the role repurposed agents play in Alzheimer disease development.

Jeffrey Cummings, MD, ScD: Repurposed Agents Within Alzheimer Disease Pipeline

“One of the things that alarmed me was the relatively small number of agents coming into the phase 1 pipeline.”

systematic review of the Alzheimer disease

 drug development pipeline led by Jeffrey Cummings, MD, ScD, revealed that research has trended towards an emphasis on nonamyloid targets, including candidate treatments addressing inflammation, synapse and neuronal protection, vascular factors, neurogenesis, and epigenetic interventions. The results also showed that while there are fewer total agents within the pipeline, there has been an increase in repurposed agents and in those in phase 3 trials.

The recent biologics license application for aducanumab has brought a level of hope to the Alzheimer community, as it is positioned to potentially become the first FDA-approved drug for the reduction of clinical decline in AD, as well as the first to demonstrate clinical benefit through amyloid-beta removal. As researchers continue to search for disease-modifying treatments, Cumming’s data shows a general mix of trials that evaluate agents, biomarkers, and lifestyle factors that can lower the risk of developing AD.  

Cummings, who is director emeritus of the Lou Ruvo Center for Brain Health at Cleveland Clinic and vice chair of the Department of Brain Health at the University of Nevada—Las Vegas, sat down with 

 in this interview to share his thoughts on what is currently the greatest need in AD, as well as his reactions and surprises to the data.

The director emeritus of the Lou Ruvo Center for Brain Health at Cleveland Clinic and vice chair of the Department of Brain Health at the University of Nevada–Las Vegas discussed the leading challenges for those with Alzheimer disease.

Jeffrey Cummings, MD, ScD: Greatest Unmet Needs in Alzheimer Disease

“Whatever happens we’re going to learn a ton about drug development and how the FDA views these things by what happens to aducanumab.”

In early July, Biogen announced that it had 

completed and submitted a biologics license application (BLA) for its investigational agent aducanumab

 for the treatment of Alzheimer disease (AD). If approved, aducanumab would become the first treatment for the reduction of clinical decline in Alzheimer, as well as the first to demonstrate clinical benefit through amyloid-beta removal.

Aducanumab was also listed among the more notable agents within Jeffrey Cummings, MD, ScD, and colleagues’ 2020 AD systematic pipeline review. Cummings, who is the director emeritus of the Lou Ruvo Center for Brain Health at Cleveland Clinic and vice chair of the Department of Brain Health at the University of Nevada-Las Vegas, understands the landscape-altering magnitude the possible approval of aducanumab could have with its upcoming FDA decision.

, Cummings details his knowledge of the Biogen agent, its history thus far in its clinical development, and what is on the horizon for the drug going forward.

Biogen Completes Submission of Biologics License Application to FDA for Aducanumab as a Treatment for Alzheimer’s Disease [press release]. Cambridge, MA. Biogen. Published July 8, 2020. Accessed July 8, 2020. globenewswire.com/news-release/2020/07/08/2059186/0/en/Biogen-Completes-Submission-of-Biologics-License-Application-to-FDA-for-Aducanumab-as-a-Treatment-for-Alzheimer-s-Disease.html

The director emeritus of the Lou Ruvo Center for Brain Health at Cleveland Clinic and vice chair of the Department of Brain Health at the University of Nevada&shy;–Las Vegas gives his thoughts on the latest aducanumab update and its potential as a treatment for Alzheimer disease.

Jeffrey Cummings, MD, ScD: Where Aducanumab Stands in Alzheimer Clinical Pipeline

“I think it’s clear that the use of biomarkers has been so informative in terms of helping us to know whether the drugs are working, and whether they’re working on the biology that we’re targeting.”

Jeffrey Cummings, MD, ScD, and colleagues recently published a systematic review of Alzheimer disease (AD) treatments that are currently in development, which included a multitude of various data  on the different investigational therapies and their targets. The annual review allows for better understanding of current research priorities, trends in the pipeline, and where improvements need to be made.

Among the many observations, Cummings noted that there has been a progressive emphasis on nonamyloid targets, including candidate treatments addressing inflammation, synapse and neuronal protection, vascular factors, neurogenesis, and epigenetic interventions. The year-over-year numbers showed that there are fewer agents in the AD pipeline in 2020 than 2019 (121 versus 134), with 29 agents being assessed in 36 phase 3 trials. 

 to discuss the results of his study, including notable improvements and trends seen observed over the past 5 years. 

The director emeritus of the Lou Ruvo Center for Brain Health at Cleveland Clinic and vice chair of the Department of Brain Health at the University of Nevada-Las Vegas, details trends in Alzheimer disease research over the past few years.

Author | Jeffrey Cummings, MD, ScD

Articles

Jeffrey Cummings, MD, ScD: Repurposed Agents Within Alzheimer Disease Pipeline

Jeffrey Cummings, MD, ScD: Greatest Unmet Needs in Alzheimer Disease

Jeffrey Cummings, MD, ScD: Where Aducanumab Stands in Alzheimer Clinical Pipeline

Jeffrey Cummings, MD, ScD: Trends in the Alzheimer Disease Clinical Pipeline