The development of drugs for the treatment of Alzheimer’s is accelerating, with a record number of clinical studies in full swing. One problem that researchers face, however, is that a shortage of patients. According to a report from the University of Nevada, there are thousands of patients missing from the currently nearly 200 clinical studies underway.
Alzheimer’s disease is a neurodegenerative disease that affects millions of people globally. “We are facing an acute global crisis regarding Alzheimer’s. There is no cure for this disease and current treatment options are inadequate,” said Maria C. Carrillo, director of research at the Alzheimer’s Association.
Several new treatments on the market
Although there is an urgent need for effective treatments, it is only recently that they have begun to appear on the market. One 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 plaque is Leqembi, developed by Eisai and Biogen under license from Swedish BioArctic. Another treatment that is on its way to the market is developed by Eli Lilly. The company recently presented positive phase III results with its Alzheimer’s candidate donanemab. Learn more.
Record number of studies
According to a report published in the journal Alzheimer’s & Dementia: Translational Research and Clinical Interventions, there are currently 187 ongoing clinical studies with drugs targeting the disease. This is the highest number recorded so far. Some examples can be found here at home in Sweden in Alzecure with its candidate ACD856 and Alzinova with ALZ-101.
A driving factor behind the growing number of studies is the pharmaceutical industry’s increased investments in the field. Of all the studies that are ongoing, about 58 per cent are currently sponsored by the pharmaceutical industry.
Studies need over 50,000 patients
Although there are a large number of drugs under development, there is also a shortage of patients who can participate in the clinical studies. According to a report from University of Nevada, Las Vegas (UNLV), at least 50,000 patients are needed to be able to conduct the current clinical studies effectively.
Recruitment for phase II and phase III studies is challenging and the average recruitment time is currently more 100 weeks. In some studies, the recruitment time may even exceed 200 weeks. The time frame for phase I studies is only slightly shorter.
According to Maria C. Carrillo, many patients are not aware of the possibility of participating in clinical studies, which contributes to the problem. Carrillo emphasises, “It is critical that patients and their families access and understand clinical trial information. Their participation is crucial for progress.”
Strict rules an obstacle
According to her, there is also a problem with strict criteria for participation in the studies. Many patients are excluded because of these criteria, leading to a decrease in potential participants. “By broadening the criteria, we can include more patients and get a more robust set of data,” Carrillo comments.
She thinks it is clear that there is an urgent need to solve the problem of patient shortage in clinical trials for Alzheimer’s and concludes:
“To find effective treatments for this devastating disease, it is critical that we engage a broad population of patients in these studies.”