The publication Being Patient tracks the latest news about Alzheimer’s disease. This month it published an article about a new Alzheimer’s clinical trial that is being conducted with the goal of defeating beta-amyloid symptoms before they develop. The trial focus will be on people who are asymptomatic.
The year 2019 was very disappointing for patients and scientists when Biogen withdrew its drug aducanumab that looked promising but instead was tossed aside for supposed lack of efficacy.
Now University of Southern California (USC) researchers are trying a new approach. A new trial testing the drug should be underway in several months.
The medication is designed to adhere to the brain’s beta-amyloid plaques. In doing so, the drug would give an assist to the immune system by targeting toxic proteins and then eliminating them.
Previous Clinical Trials
Aducanumab had been tested in phase 2 clinical trial where the drug proved it could remove the amyloid from the brain.
The researchers are moving forward to investigate whether this will result in a reduction of cognitive decline.
The Focus is on Beta-amyloid
The protein beta-amyloid has been proven to be one of the drivers of neurodegenerative diseases. Drug developers and researchers have been focusing on beta-amyloid in their quest to find an effective treatment for Alzheimer’s disease.
Beta-amyloid is the main element of brain lesions or plaques that are characteristic of Alzheimer’s. It is estimated that they are present in the brain of approximately four million Americans diagnosed with the disease.
Two Steps Forward and One Step Back
Although Biogen canceled aducanumab last year, it did reverse that decision and hopes to bring the drug to market approval.
Researchers were able to provide evidence that aducanumab did, in fact, slow Alzheimer’s progression and reduced amyloid. The new clinical trial will be recruiting patients in March 2020.
Two more recent setbacks came from the failure of two drugs designed to fight amyloid. The drugs were developed by Eli Lilly and Roche.
Voicing Confidence in Aducanumab
Being Patient interviewed one of the investigators of the trial, Paul Aisen, M.D., the director of the Therapeutic Research Institute at USC. Dr. Aisen explained that the new trial is a substantial improvement from other studies of beta-amyloid because it will focus on amyloid in the pre-clinical stage.
According to Dr. Aisen, the premise is that it is better to attack the Alzheimer’s disease cascade while the brain is functioning normally. The drug will be administered to people at the early stage of the disease who have not yet exhibited symptoms. This state can last for years before people experience the onset of symptoms.
Further, in a recent press release, Dr. Aisen said that the accumulation of amyloid starts the disease process and predicts the ever-increasing cognitive decline towards dementia.
He emphasized that most of the genetic causes of Alzheimer’s known to scientists are closely associated with amyloid accumulation.
About the Trial
The trial will be an ambitious undertaking by recruiting about nine thousand subjects across one hundred sites. Sixty to seventy sites will be in North America. Additional sites will be located in Australia, Japan, and Singapore.
The subjects will be selected based on the results of PET scans.
The recruiters will be looking for signs indicating that they are:
- Cognitively normal
- In the early stage of the disease
- Have elevated levels of amyloid in the brain
- Are asymptomatic.
The Next Step
After the initial screening, about 1,400 subjects will start receiving aducanumab, possibly beginning the summer of 2020. The treatment will be administered for four years.
Dr. Aisen again expressed confidence that the drug will slow or even halt cognitive decline. He offered information here to enable the enrollment in the Alzheimer’s Prevention Trial Web study.
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