From the WUSTL Newsroom…
Leading scientists have selected the first drugs to be evaluated in a worldwide clinical study to determine whether they can prevent Alzheimer’s disease.
The pioneering trial, expected to start by early 2013, initially will test three promising drugs, each designed to target Alzheimer’s in different ways.
In people with inherited mutations that cause early-onset Alzheimer’s, the study will seek to identify whether the drugs can improve Alzheimer’s disease biomarkers and effectively prevent the loss of cognitive function.
“This trial is the result of a groundbreaking collaboration between academic institutions, pharmaceutical companies and patient advocacy groups, with key support from regulatory groups,” says principal investigator Randall Bateman, MD, the Charles F. and Joanne Knight Distinguished Professor in Neurology at Washington University School of Medicine in St. Louis. “We are excited that this diverse portfolio of drugs and approaches will accelerate the discovery of an effective treatment for Alzheimer’s.”
The trial will be conducted by the Dominantly Inherited Alzheimer’s Network Trials Unit (DIAN TU) at Washington University School of Medicine in St. Louis. The trials unit is supported by the DIAN, an NIH-funded collaboration of world-leading Alzheimer’s research centers; the Alzheimer’s Association; and the DIAN Pharma Consortium, composed of 10 pharmaceutical companies that have been advising DIAN researchers on the planning of the trial.
Alzheimer’s researchers have selected the investigational drugs from more than a dozen nominations submitted by the DIAN Pharma Consortium. Each drug has a unique approach to counter the toxic effects of amyloid beta, the main ingredient of brain plaques found in Alzheimer’s patients. Each also has passed earlier clinical trials that evaluated safety and effectiveness of the drugs and whether they engaged their targets in patients.
The investigational drugs are Gantenerumab, Solanezumab, and a beta-secretase (BACE) inhibitor, a small molecule in Phase II clinical trials that was also discovered and developed by Lilly.
“Trying to prevent Alzheimer’s symptoms from ever occurring is a new strategy,” says John C. Morris, MD, principal investigator of DIAN and the Harvey A. and Doris Friedman Distinguished Professor of Neurology at the School of Medicine. “We are most appreciative of the support this approach has received.”
The trial will involve 160 people who have inherited mutations that mean they are almost certain to develop Alzheimer’s at a young age, typically in their 30s, 40s or 50s. The trial also will monitor the health of 80 DIAN participants who did not inherit the Alzheimer’s mutations.
For more from Michael C. Purdy of the WUSTL Newsroom, click here.
For a related story from MSNBC, click here.