Study: Alzheimer's Pipeline, Trials Need Attention
By Cyndi Root
Considering the magnitude of the problem, Alzheimer’s disease (AD) clinical trials have been limited, according to a new study in the journal Alzheimer’s Research & Therapy. Investigative agents do not pass from phase to phase readily and few make it to regulatory review, coming in at a lower rate compared to other therapeutic areas.
Authors examined Clinicaltrials.gov for AD trials from 2002 to 2012 to autopsy the drug development process for AD drugs in an effort to improve the current environment and approve effective agents. They found that pharmaceutical companies sponsored 78 percent of trials, with the U.S. having the largest number of trials. Trials evaluated agents that treated symptoms of declining cognition and agents that attempted to modify the disease state, such as immunotherapies. In the study period, sponsors completed 413 AD trials, with only 83 proceeding to Stage III. Authors state that the overall failure rate was 99.6 percent.
Study authors conclude that the AD drug-development ecosystem needs work and that there is an urgent need for new AD therapies. Currently, only 22 agents are in Phase I trials, which the authors emphasize is a small number, worthy of concern.
Alzheimer’s Drug Pipeline
Study authors state, “The current AD pipeline is relatively modest, given the enormous challenge posed by this disease.” Currently, 108 clinical trials for AD agents are ongoing, with approaches including immunotherapies, repurposed drugs, and devices. Entities such as pharmaceutical companies, academic laboratories, federally funded agencies, and community groups are involved in AD drug discovery. However, authors say that these separate groups must be seen as an ecosystem and supported to coordinate efforts to find new therapies.
AD Investigations
The New England Journal of Medicine published the results of two trials for AD agents in its February issue, reporting disappointing results. The two investigative agents had shown promise in improving cognition, however investigators found that bapineuzumab and solanezumab were ineffective in treating patients with mild to moderate dementia.
The Alzheimer’s Association reports on AD drug development. In June, it announced in a press release that a U.S. Senate Appropriations committee allocated an additional $100 million in its fiscal year 2015 for Alzheimer's research. In March, the Association announced that it is giving $8 million over four years for the Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) study starting in 2014.