Alzheimer's disease is a neurodegenerative disease that affects millions of people globally. "We are facing an acute global crisis in Alzheimer's. There is no cure for this disease and current treatment options are inadequate," says Maria C Carrillo, Head of Research at Alzheimer's Association.
Several new treatments on the market
Despite the urgent need for effective treatments, they have only recently begun to appear on the market. An example is aduhelm, which was approved by the US FDA in June 2021. Aduhelm is an antibody drug that targets amyloid-beta plaques in the brain, one of the main pathological markers of Alzheimer's disease.
Another drug that targets the same plaques is leqembi, Eisai and Biogen developed under license from Swedish BioArcticAnother example that is on its way to market is being developed by Eli LillyThe company recently presented positive Phase III results with its Alzheimer's candidate donanemab. Read the sea.
Record number of studies
According to a report published in the journal Alzheimer's & Dementia: Translational Research and Clinical Interventions There are currently 187 clinical trials underway with drugs targeting the disease. This is the highest number recorded so far. Some examples can be found here in Sweden in Alzecure with his candidate ACD856 and Alzinova w/ ALZ-101.
A driving factor behind the growing number of studies is the pharmaceutical industry's increased investment in the field. Of all studies in progress, approximately 58 percent are currently sponsored by the pharmaceutical industry.
Studies need over 50 patients
Although there are a large number of drugs under development, there is a shortage of patients who can participate in clinical trials. According to a report from University of Nevada, Las Vegas (UNLV) needs at least 50 patients to be able to conduct current clinical studies effectively.
Recruitment to Phase II and Phase III studies is challenging and the average recruitment time is currently over 100 weeks. In some studies, the recruitment time can even exceed 200 weeks. The timeframe for Phase I studies is only slightly shorter.
According to Maria C. Carrillo, many patients are unaware of the opportunity to participate in clinical trials, which contributes to the problem. Carrillo emphasizes, “It is crucial that patients and their families have access to and understand the information about clinical trials. Their participation is essential for progress.”
Strict rules an obstacle
She also says there is a problem with strict criteria for participation in studies. Many patients are excluded due to these criteria, which leads to a reduction in potential participants. “By broadening the criteria, we can include more patients and get a more robust set of data,” comments Carrillo.
She believes it is clear that there is an urgent need to solve the problem of patient shortages in clinical trials for Alzheimer's and concludes:
“To find effective treatments for this devastating disease, it is crucial that we engage a broad population of patients in these studies.”