DAYTON — More than 75 percent of Alzheimer’s drugs currently in the clinical trial pipeline are new therapies that are disease modification drugs, which could provide new insight into what causes Alzheimer’s disease.
At the Alzheimer’s Association’s International Conference, new data and analyses of the furthest advanced investigational anti-amyloid drugs – Donanemab (Eli Lilly) and Lecanemab (Eisai/Biogen) – plus a wide variety of other approaches, including anti-tau strategies, anti-inflammatory targets and neuroprotection and regenerative medicine were presented.
With FDA-accelerated approval of Aducanumab (Aduhelm) for mild cognitive impairment and mild Alzheimer’s, there is new energy and interest in other treatments in the Alzheimer’s/dementia therapeutic pipeline.
Aducanumab (Aduhelm) is the first drug that demonstrates that removing amyloid from the brain may delay clinical decline in people living with Alzheimer’s. Amyloid is the protein that clumps into sticky brain plaques that are a hallmark of Alzheimer’s disease.
“As the leading voluntary health organization in Alzheimer’s research, care and support, the Alzheimer’s Association believes we’re living in a new era of advancement,” Maria C. Carrillo, Alzheimer’s Association chief science officer, said. “We’re seeing at AAIC this year dozens of novel treatment approaches that are gaining momentum in clinical trials. Alzheimer’s is a complex brain disease and very likely will need multiple treatment strategies that address the disease in several different ways along the length of its course. These treatments, once discovered and approved, may then be combined into powerful combination therapies.”
According to statistics compiled from clinicaltrials.gov, this year there are 126 unique therapies in 152 clinical trials for Alzheimer’s disease. Just over 82 percent are for disease modification, 10.3 percent are for cognitive enhancement, and 7.1 percent target behavioral and neuropsychiatric symptoms. While Aducanumab is an IV infusion drug, 70.2 percent of the small molecule therapies in the pipeline are mainly taken orally.
Eric VanVlymen, executive director of the Alzheimer’s Association Miami Valley Chapter, said the association has always believed that Aducanumab is the first of a number of treatments to come. To advance the science, VanVlymen said there is an urgent need for a diverse group of clinical trial participants to ensure that new drugs are viable for all. In fact, more than 38,000 people are needed for currently recruiting trials, according to the Alzheimer’s Association.
The Alzheimer’s Association TrialMatch is a service that provides customized lists of clinical studies based on user-provided information. The free platform allows individuals to see which studies are a good fit for them or a family member. Individuals can search for studies, sign up for study updates or connect with researcher teams. To register for TrialMatch, search Alzheimer’s Association TrialMatch online to get started.
Alzheimer’s is a progressive, fatal brain disease that kills nerve cells and tissues in the brain, affecting an individual’s ability to remember, think, plan, speak and walk. In Ohio, 220,000 individuals, ages 65 and older, are living with the disease.
Eisai/Biogen has announced its intent to seek expedited regulatory approval for Lecanemab, and Eli Lilly has announced its intent to submit an application under accelerated approval pathway later in 2021 for Donanemab, based on data from the company’s Phase 2 trial, TRAILBLAZER-ALZ. That trial enrolled patients selected based on cognitive assessments in conjunction with amyloid plaque imaging and tau staging by PET imaging.
In Ohio, three clinics – Neurology Diagnostics, Inc. in Dayton; Ohio State University Medical Center in Columbus; and Insight Clinical Trials in Beachwood – participated in TRAILBLAZER-ALZ. Seven Ohio sites in Columbus, Cleveland, Cincinnati, Centerville, Canton and Dayton are recruiting patients for TRAILBLAZER-ALZ 2.